[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-and-neck-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-and-neck-squamous-cell-carcinoma":761},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,173,0,25,[9,61,100,113,139,169,230,255,296,337,372,397,422,447,468,498,516,530,560,583,612,636,666,717,741],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":40,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100054087",false,"NCT07667400","Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","Phase I\u002FII Trial of Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","* INCLUSION CRITERIA:\n\nAll Participants\n\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C= 2\n* Participants must have adequate organ and marrow function as defined below:\n\n  * ANC \\>= 1,500\u002FmcL\n  * Hemoglobin (Hgb) \\>= 9 g\u002FdL\n  * Platelets (PLTs) \\>= 100,000\u002FmcL\n  * Creatinine clearance \\>= 50 mL\u002Fmin (by Cockroft-Gault formula)\n  * Total bilirubin \\\u003C= 1.5 x iULN (\\\u003C= 3 x ULN in participants with known\u002Fsuspected Gilbert s disease)\n  * ALT\u002FAST \\\u003C= 2.5 x iULN\n  * Activated partial thromboplastin time (aPTT) \\\u003C= 1.5 x iULN\n* Contraception as follows:\n* Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) prior to study entry, for the duration of study treatment, and for up to 2 months after discontinuation of the study drugs. A participant may request a male partner to use an effective form of contraception to fulfill this requirement.\n* Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 4 months after discontinuation of the study drugs. A participant may request a female partner to use an effective form of contraception to fulfill this requirement. Men able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through one week after the last dose of study drugs.\n* Participants must be able to swallow oral medications.\n* Human immunodeficiency virus (HIV)-infected participants must have undetectable viral load (VL) and be on effective anti-retroviral therapy within 4 weeks prior to the study treatment initiation and have no history of opportunistic infections or Castleman s disease within 12 months prior to the study treatment initiation.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV VL.\n* Participants with evidence of chronic hepatitis C virus (HCV) infection must have undetectable HCV VL.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nParticipants with HNC\n\n* Histologically confirmed HNSCC (including oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses, nasopharynx) or SGC (including ACC and non-ACC) and recurrent\u002Fmetastatic (R\u002FM) or advanced incurable disease.\n* Prior treatment as follows:\n\n  * Participants with R\u002FM HNSCC must have prior systemic treatment (platinum-based chemotherapy and\u002For anti-PD(L)1 treatment).\n  * Participants with R\u002FM SGC may have any number of prior systemic treatment lines; prior systemic treatment not required for participation.\n  * Participants must not have received systemic anticancer treatment within 3 weeks prior to first treatment administration. Note: Treatment-related toxicities must have resolved to Grade \\\u003C2 or be minimal and not constitute a safety risk. Participants with SGC previously treated with hormonal therapies (e.g., drugs targeting the androgen receptor) may continue these drugs concomitantly with study therapy. Participants with bone metastases or hypercalcemia on intravenous bisphosphonate medications, denosumab, or similar agents, are eligible to participate and may continue this treatment.\n* Presence of \\>= 1 measurable lesion by RECIST v 1.1 criteria.\n\nParticipants with mCRPC\n\n* Documented histopathological confirmation of prostate cancer. If no pathologic report or specimen is available, participants may enroll with a history of clinical course consistent with the disease.\n* Participants must have mCRPC, defined as at least one lesion on TC-99 bone scan or at least one lesion that is measurable per RECIST 1.1.\n* Participants must need ADT as part of their cancer therapy (unless previous orchiectomy)\n* Castrate testosterone level (\\\u003C50 ng\u002Fdl or 1.7 nmol\u002FL)\n* Prior treatment as follows:\n\n  * DTX for mCRPC is allowed but participants must not have had progression while on docetaxel or within 3 months after completing DTX for mCRPC\n  * Participants must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.\n* Progression defined as two consecutive rising PSA values at least 1 week apart or radiographic evidence of progression seen on computed tomography (CT) scan or TC- 99 bone scan.\n* Toxicities related to prior therapy, including surgery and\u002For radiation, must have resolved to \\\u003C Grade 1 per CTCAE v.6.0.\n\nEXCLUSION CRITERIA:\n\nAll participants\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to DTX, SX-682, or other agents used in study (e.g., polysorbate 80).\n* Known active brain metastases. Note: Participants with previously treated brain metastases are eligible if imaging at least four weeks prior to first trial treatment shows no evidence of progression and neurologic symptoms have resolved, have no new or enlarging brain metastases, and are not using glucocorticoids for at least a week prior to first trial treatment\n* Participants must not have received other investigational agents within 3 weeks prior to the first dose of the study drug(s).\n* Participants must not have received major surgery within 14 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted). If participant underwent major surgery, they must have recovered adequately (according to the Principal Investigator) from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n* Treatment (systemic) with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A4) listed at https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-druginteractions- table-substrates-inhibitors-and-inducers#table2-2,table3-3,table5-2 within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment.\n* Prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or efficacy assessment of the study treatment.\n* Participants with serious uncontrolled intercurrent illness evaluated by medical history, electrocardiogram (EKG), and physical exam that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.\n\nParticipants with HNC\n\n* Participants must not have received large-field radiotherapy within 2 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved to Grade \\\u003C2 (except for radiation-induced xerostomia\u002Fdysgeusia) or be minimal and not constitute a safety risk.\n* Positive pregnancy serum or urine beta-human chorionic gonadotropin (beta-hCG) test\n\nParticipants with mCRPC\n\n* Use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 1 week prior to the study treatment initiation.\n* Cancer related neuropathy at screening\n* Baseline QTcF \\>= 470 ms","ALL","18 Years","120 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nHead and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands. Prostate cancer is the most common cancer in men in the United States. Survival rates for these cancers are lower than 50% if they spread to other parts of the body or return after treatment. Better treatments are needed.\n\nObjective:\n\nTo test a new drug (SX-682), combined with an approved drug (docetaxel, or DTX), in people with HNCs or prostate cancer.\n\nEligibility\n\nPeople aged 18 years and older with an HNC or prostate cancer that has returned after treatment or has spread.\n\nDesign:\n\nParticipants will be screened. They will have blood tests, imaging scans, and a test of their heart function. A tissue sample (biopsy) of the tumor may be taken.\n\nParticipants will take the study drugs in 3-week cycles. SX-682 is a tablet taken by mouth twice a day from Days 1 to 11 of each cycle. Participants will get a supply of the drug to take home. DTX is given on Day 8 of each cycle through a tube attached to a needle inserted into a vein in the arm. Participants will come to the clinic on Days 1 and 8 of every cycle. They will take both drugs for up to 6 cycles.\n\nParticipants will have follow-up visits 1 week and 1 month after they finish taking the drugs. Follow-ups will continue every 3 months for 2 years. Then they will have phone or email check-ins twice a year until 5 years have passed.",[28,29,30,31,32,33,34,35,36,37,38,39],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Paranasal Sinus Neoplasms","Nasopharyngeal Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Hypopharyngeal Cancer","Carcinoma of Larynx","Oral Squamous Cell Carcinoma","Salivary Gland Cancer","Adenoid Cystic Carcinoma","Prostate Cancer","Metastatic Castration Resistant Prostate Cancer",[41,42,43,44,45,46,47],"Solid Tumors","Infusion","Chemotherapy","Carcinoma","Head and Neck","Prostate","molecule inhibitor","NOT_YET_RECRUITING","2026-07-10",{"date":51,"type":52},"2026-07-13","ACTUAL",{"date":54,"type":21},"2026-07-16",{"date":56,"type":21},"2037-10-01",{"name":58,"class":59},"National Cancer Institute (NCI)","NIH",1,{"id":62,"slug":4,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":70,"conditions":71,"keywords":79,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100054097","NCT05877599","A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation","An Open-label, Phase 1, Multicentre Platform Study to Evaluate the Safety and Preliminary Anti-tumour Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Participants With Advanced Malignancies That Are Positive for the TP53 R175H Mutation","Key Inclusion Criteria (Module 1)\n\n* Subjects must be at least 18 years of age\n* Subject must be diagnosed with one of the histologies below:\n\n  * NSCLC\n  * Colorectal adenocarcinoma\n  * HNSCC\n  * Pancreatic adenocarcinoma\n  * Breast cancer\n  * Ovarian cancer\n  * Any other solid tumor\n* Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Subject has at least 1 measurable lesion\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n* Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n\nKey Exclusion Criteria (Module 1)\n\n* Any another primary malignancy within the 3 years prior to enrollment\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.\n\nKey Inclusion Criteria (Module 2 - hematological malignancies)\n\n* At least 18 years of age\n* Diagnosis of AML or MDS that allows for efficacy assessments\n* Confirmation of TP53 R175H variant mutation in cancer cells\n* Subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* ECOG performance status of 0 to 1\n\nKey Exclusion Criteria (Module 2 - hematological malignancy)\n\n* Acute promyelocytic leukaemia or isolated extramedullary disease\n* Another primary malignancy within 2 years (with exceptions)\n* HSCT within 100 days or immunosuppression for GvHD within 4 weeks\n* History of CNS or other extramedullary leukaemic involvement unless a lumbar puncture is negative for leukemic cells\n* Prior stroke, ischemic attack, significant cardiac disease, heart failure\n* Prior adoptive modified cell therapy\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.",{"count":68,"type":21},45,[24],"Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies",[72,29,73,74,75,76,77,78],"Non-small Cell Lung Cancer","Colorectal Carcinoma","Pancreatic Adenocarcinoma","Breast Cancer","Other Solid Tumors","Ovarian Cancer","Myeloid Neoplasms (AML\u002FMDS)",[80,81,82,83,84,85,86,75,77,87,88,89],"Cell therapy","TP53","Solid tumors","Non-small cell lung cancer","Head and neck squamous cell carcinoma","Colorectal carcinoma","Pancreatic adenocarcinoma","AML","MDS","TCR","RECRUITING",{"date":51,"type":52},{"date":93,"type":52},"2023-07-12",{"date":95,"type":21},"2029-07-31",{"name":97,"class":98},"AstraZeneca","INDUSTRY",18,{"id":101,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":26,"conditions":104,"keywords":105,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":112,"locationsCount":60},"100643883",{"count":20,"type":21},[24,25],[28,29,30,31,32,33,34,35,36,37,38,39],[41,42,43,44,45,46,47],"2026-07-01",{"date":108,"type":52},"2026-07-02",{"date":110,"type":21},"2026-07-07",{"date":56,"type":21},{"name":58,"class":59},{"id":114,"slug":4,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":134,"leadSponsor":136,"locationsCount":60},"100644941","NCT07677475","MRG003 Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma","MRG003 (Becotatug Vedotin) Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma: A Multicenter, Prospective, Randomized, Controlled Phase II Trial","1. Histologically or cytologically confirmed head and neck squamous cell carcinoma (HNSCC), PD-L1 positive (CPS ≥ 1)\n2. Treatment-naïve, pathologically confirmed stage III-IVA resectable non-oropharyngeal HNSCC (oral cavity, larynx, hypopharynx) OR HPV-negative oropharyngeal SCC, OR HPV-positive stage III T4N0-2 resectable oropharyngeal cancer (AJCC 8th edition)\n3. No prior antitumor treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy)\n4. Age 18 to 70 years\n5. ECOG performance status 0 or 1\n6. Adequate organ function within 14 days before first dose (no blood products or growth factors within 14 days):\n\n   * ANC ≥ 1.0 × 10⁹\u002FL, Hb ≥ 90 g\u002FL, PLT ≥ 75 × 10⁹\u002FL\n   * ALT\u002FAST ≤ 1.5 × ULN, total bilirubin ≤ 1.5 × ULN, ALP \\\u003C 2.5 × ULN\n   * CrCl ≥ 50 mL\u002Fmin (Cockcroft-Gault)\n   * APTT and INR ≤ 1.5 × ULN\n7. At least one measurable lesion per RECIST 1.1\n8. Life expectancy ≥ 12 weeks\n9. Female subjects of childbearing potential and male subjects with reproductive potential must use medically accepted contraception during treatment and for 3 months after last dose\n10. Voluntary signed informed consent, good compliance, willing to undergo follow-up","70 Years",{"count":121,"type":21},65,[25],"This is a multicenter, randomized, open-label, controlled Phase 2 trial evaluating neoadjuvant MRG003 (anti-EGFR ADC) plus toripalimab versus toripalimab alone in PD-L1-positive (CPS ≥ 1), resectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Patients are randomized 2:1 to receive 2 cycles of MRG003 2.0 mg\u002Fkg IV plus toripalimab 240 mg IV Q3W (n=43) or toripalimab 240 mg IV Q3W alone (n=22), followed by surgery and risk-adapted adjuvant therapy including radiotherapy and toripalimab maintenance. The primary endpoint is Major Pathological Response (MPR) rate. Secondary endpoints include pCR, ORR, EFS, R0 resection rate, surgical down-staging, and safety. Enrolling 65 participants across 11 centers in China.",[29],[126,127,128,129],"MRG003","Vebecototagene Autoleucovorin","Toripalimab","Neoadjuvant Therapy","2026-06-28",{"date":132,"type":52},"2026-06-30",{"date":132,"type":21},{"date":135,"type":21},"2029-06-30",{"name":137,"class":138},"Dongguan People's Hospital","OTHER_GOV",{"id":140,"slug":4,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":153,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":168},"100573538","NCT06747585","A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors","A Phase I\u002FII, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous Solid Tumors","Inclusion Criteria:\n\n* Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, HNSCC (nasopharyngeal cancer included), ESCC or CSCC.\n* Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment.\n* Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment.\n* Have provided tissue for CLDN1 analysis in a central laboratory.\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.\n* Demonstrate adequate bone marrow and organ function.\n* Patients must have recovered from all toxicities led by prior treatment.\n* Have measurable disease based on RECIST 1.1 as determined by the site.\n\nExclusion Criteria:\n\n* Diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma.\n* Has received antineoplastic therapies prior to study intervention within specified time frame.\n* Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain).\n* Patients with uncontrolled diabetes.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has clinically significant gastrointestinal bleeding and has an active infection requiring systemic treatment and has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate.\n* Concomitant use of drugs that are known to prolong or shorten QT and\u002For have known risk of Torsades de Pointes.",{"count":146,"type":21},170,[24,25],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P02 monotherapy in adult patients with selected squamous solid tumors.",[150,29,151,152],"Squamous Non-small-cell Lung Cancer","Cervical Squamous Cell Carcinoma","Esophageal Squamous Cell Carcinoma",[154,155,156,157,158],"Claudin-1 Targeted Antibody-Drug Conjugate","Monotherapy","First-in-Human","Recommended Phase 2 dose","Recommended dose for expansion","2026-06-26",{"date":161,"type":52},"2026-06-29",{"date":163,"type":52},"2024-12-16",{"date":165,"type":21},"2028-08-15",{"name":167,"class":98},"Alentis Therapeutics AG",41,{"id":170,"slug":4,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":229},"100556989","NCT06532279","Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer","A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation","Inclusion Criteria:\n\n* Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy. Patients planned to receive concurrent cisplatin and radiation therapy in the adjuvant setting are not eligible.\n* At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least 1cc or 1% of the subsite volume receiving \\>= 50 Gy. In cases of uncertainty, the enrolling clinician can ensure coverage by inspecting the 50 Gy isodose line and using the table describing the anatomic boundaries of the individual subsites contained within the extended cavity contour. The two or more subsites receiving \\>= 50 Gy must be documented by the enrolling physician.\n* Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.\n* P16 and\u002For human papillomavirus (HPV) status (via polymerase chain reaction \\[PCR\\] or in situ hybridization \\[ISH\\]) must be documented for patients with oropharynx cancer.\n* No patients with T0\u002FTx\u002Funknown primary disease.\n* No definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.\n* Able to receive intensity-modulated radiation therapy (IMRT) delivered as daily fractions of 2.0 Gy once per weekday with a cumulative radiation dose of 70 Gy.\n* Age \\>= 18.\n* Zubrod performance status of 0-2.\n* Potassium ≥ institutional lower limit of normal (LLN) and magnesium ≥ institutional LLN. Oral or intravenous (IV) replacement therapy of potassium or magnesium is permitted if parameters can be met after repletion.\n* Absolute neutrophil count (ANC) \\>= 1,500 cells\u002Fmm\\^3.\n* Platelets \\>= 100,000 cells\u002Fmm\\^3.\n* Hemoglobin \\>= 9.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 10.0 g\u002Fdl is acceptable).\n* Adequate renal function defined as creatinine clearance (CrCL) \\> 50 mL\u002Fmin by the Cockcroft-Gault formula.\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN) (not applicable to patients with known Gilbert's syndrome).\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN.\n* No prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer, e.g., breast cancer with irradiation of the supraclavicular fossa\u002Flevel 4 neck.\n* No concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.\n* No prior history of gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.\n* No current treatment of adjuvant post-operative (op) chemoradiation.\n* No systemic treatment with inducers or strong inhibitors of cytochrome P450 =\\\u003C 4 days before registration. Note: Patients undergoing steroid treatment as a component of the anti-emetic regimen for cisplatin are eligible for the study. Treatment with the antifungal medications, nystatin, fluconazole , miconazole and clotrimazole are allowed.\n* No prior induction chemotherapy treatment.\n* No prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell skin carcinoma, resected T1-2N0M0 differentiated thyroid cancers, Ta bladder cancers, or low risk prostate cancer.\n* No clinically significant hearing impairment that precludes cisplatin, as per physician assessment.\n* No serious cardiovascular disease or cerebrovascular disease in the last 6 months prior to study enrollment; defined as a cerebrovascular accident, myocardial infarction, unstable angina, serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment, or current New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or admission within last 6 months for CHF exacerbation; (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification).\n* No valvular heart disease.\n* No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment.\n* No history or evidence upon physical\u002Fneurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication.\n* No acute bacterial, viral, or fungal infection requiring intravenous antimicrobials within 7 days of enrollment.\n* No history of chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration.\n* No known personal or family history of long QT Syndrome; no marked baseline prolongation of QT\u002Fcorrected QT (QTc) interval (i.e., ≥ 2 electrocardiograms \\[EKGs\\] in prior 3 months of a QTc interval \\> 450 milliseconds (ms) for males and \\> 470 ms for females using the specific\u002Fusual choice by clinical center for correction factor.\n* Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities must be reversible to ≤ grade 1 with supplementation.\n* No poorly controlled hypertension (systolic blood pressure \\[SBP\\] \\> 160 and\u002For diastolic blood pressure \\[DBP\\] \\> 95) over 2 repeated measures within 30 days prior to registration.\n* No grade \\>= 2 oral mucositis per CTCAE version 5.0.\n* No grade \\>= 2 hypotension per CTCAE v. 5.0.\n* No medical necessity for anti-arrhythmics with significant risk of QTc prolongation such as class I and class III anti-arrhythmics. These include but are not limited to amiodarone, quinidine, dofetilide, sotalol, flecainide, and lidocaine.\n* No medical necessity for medications listed as prohibited.\n\n  * For standard management of oral mucositis, clinicians may consult the Multinational Association of Supportive Care in Cancer\u002FInternational Society of Oral Oncology (MASCC\u002FISOO) Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. The only intervention against mucositis that is supported by level I evidence is low-level laser therapy (LLLT). Honey is rated at level II and benzydamine, which isn't available in the United States (US), is rated at level III. There are no other positively rated interventions.\n  * LLLT is prohibited in this study as its availability remains limited, it is not Food and Drug Administration (FDA) approved in the US, and it is considered investigational in many circumstances requiring enrollment in a dedicated protocol who requirements could conflict with this one. Therefore, institutions that use LLLT should only enroll patients who would not be eligible for (or do not want) that intervention. Honey is not on the list of prohibited medications for this study. Given the MASCC recommendation, benzydamine is allowed, although there is lack of availability in the United States of America (USA). The other listed prohibited medications are not recommended by MASCC and some are potentially harmful, such as glutamine, which is associated with mortality in patients receiving stem cell transplant.\n* No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).\n* Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.",{"count":176,"type":21},98,[25],"This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Oral mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing. Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. BMX-001 neutralizes harmful substances in the body, preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues. Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer.",[180,181,182,29,183,184,185,186,32,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218],"Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma","Nasopharyngeal Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","Stage 0 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage 0 Hypopharyngeal Carcinoma AJCC v8","Stage 0 Nasopharyngeal Carcinoma AJCC v8","Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage I Hypopharyngeal Carcinoma AJCC v8","Stage I Laryngeal Cancer AJCC v8","Stage I Lip and Oral Cavity Cancer AJCC v8","Stage I Nasopharyngeal Carcinoma AJCC v8","Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage II Hypopharyngeal Carcinoma AJCC v8","Stage II Laryngeal Cancer AJCC v8","Stage II Lip and Oral Cavity Cancer AJCC v8","Stage II Nasopharyngeal Carcinoma AJCC v8","Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage III Hypopharyngeal Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Lip and Oral Cavity Cancer AJCC v8","Stage III Nasopharyngeal Carcinoma AJCC v8","Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVA Hypopharyngeal Carcinoma AJCC v8","Stage IVA Laryngeal Cancer AJCC v8","Stage IVA Lip and Oral Cavity Cancer AJCC v8","Stage IVA Nasopharyngeal Carcinoma AJCC v8","Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVB Hypopharyngeal Carcinoma AJCC v8","Stage IVB Laryngeal Cancer AJCC v8","Stage IVB Lip and Oral Cavity Cancer AJCC v8","Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stomatitis","2026-06-22",{"date":221,"type":52},"2026-06-25",{"date":223,"type":52},"2025-06-23",{"date":225,"type":21},"2027-01-01",{"name":227,"class":228},"NRG Oncology","OTHER",153,{"id":231,"slug":4,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":238,"briefSummary":239,"conditions":240,"keywords":244,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100495068","NCT05726370","Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC","A Phase 2 Study of Preoperative Pembrolizumab and Chemotherapy Followed by Adjuvant Pembrolizumab in Resectable Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed locoregionally recurrent squamous cell carcinoma of the head and neck, or second primary HNSCC in a previously irradiated field, defined as \\>50% of the presurgical tumor volume having prior radiation dose of \\>45 Gy as determined by the treating radiation oncologist (including primary sites, such as oral cavity, oropharynx, larynx or hypopharynx carcinoma).\n* Participants must be a candidate for curative intent surgery.\n* Participants must have documented time of ≥ 6 months from completion of prior curative intent treatment for HNSCC (surgery and\u002For radiation therapy with\u002Fwithout platinum chemotherapy or cetuximab targeted therapy) to diagnosis of local or locoregional recurrence or a second primary in a previously irradiated field.\n* Participants must be willing to undergo a mandatory pre-treatment biopsy and willing to provide blood and tissue from the pre-treatment biopsy and at the time of surgery. Exceptions may be made after discussion with sponsor if it is not medically feasible to obtain a pre-treatment biopsy or is in the best interest of the patient. Archival tissue may be collected in this situation. Participants will be offered the opportunity to volunteer for optional biopsies at the time of recurrence of disease.\n* Participants may have any smoking history (no restrictions)\n* Participants may have any Human Papilloma Virus (HPV) status of the tumor. Patients with oropharyngeal cancer are required to undergo HPV testing with p16 immunohistochemistry and\u002For confirmatory HPV PCR or ISH testing\n* Age ≥18 years\n* ECOG performance status 0 or 1 (Karnofsky ≥70%, see Appendix A)\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * total bilirubin ≤ institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n  * creatinine ≤ institutional ULN OR\n  * glomerular filtration rate (GFR) ≥50 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* Because pembrolizumab and chemotherapy can be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.\n* Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix B), not breastfeeding, and at least one of the following conditions applies:\n\n  * a. Not a woman of childbearing potential (WOCBP) as defined in Appendix B OR\n  * b. A WOCBP who agrees to follow the contraceptive guidance in Appendix B during the treatment period and for at least 180 days after the last dose of study treatment.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Sinonasal, nasopharyngeal or cutaneous primary site of squamous cell carcinoma of the head and neck\n* Has known distant metastatic disease. Those with known brain metastases should be excluded from this clinical trial, because of the poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, baseline brain imaging is not required prior to enrollment in the study if patients are asymptomatic\n* Has had chemotherapy or radiotherapy for HNSCC in curative intent setting within 6 months prior to entering the study.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* Has a history of allergic reactions to agents used in study\n* Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has an active infection requiring systemic therapy\n* Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Has not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 2) with the exception of alopecia\n* Has had an allogeneic tissue\u002Fsolid organ transplant\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to study registration (see Appendix B). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Pregnant women are excluded from this study because pembrolizumab and chemotherapy agents have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pembrolizumab and chemotherapy, breastfeeding should be discontinued if the mother is treated on this protocol.",{"count":237,"type":21},28,[25],"This research study is evaluating effectiveness and safety of a combination of immunotherapy drug, pembrolizumab, with chemotherapy, as a possible treatment before and after surgery for squamous cell carcinoma of the head and neck (HNSCC). The combination of pembrolizumab and chemotherapy will be given prior to your surgery, while immunotherapy pembrolizumab will be continued for approximately 1 year after surgery.\n\nThe names of the study drugs involved in this research study are:\n\n* pembrolizumab (a type of immunotherapy)\n* docetaxel (a type of chemotherapy)\n* cisplatin (a type of chemotherapy)\n* carboplatin (a type of chemotherapy)",[29,28,241,242,243],"Resectable Head and Neck Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Second Primary Squamous Cell Carcinoma of the Head and Neck",[29,28,241,242,243],"2026-06-21",{"date":247,"type":52},"2026-06-23",{"date":249,"type":52},"2023-05-20",{"date":251,"type":21},"2030-05-20",{"name":253,"class":228},"Dana-Farber Cancer Institute",2,{"id":256,"slug":4,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":264,"conditions":265,"keywords":272,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":295},"100439677","NCT05005403","Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan","A Global First-in-Human Study in NSCLC, HNSCC, and Solid Tumors With Azirkitug as a Single Agent and in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan","Inclusion Criteria:\n\n* Pre Treatment biopsy or archive tissue within 6 months without intervening treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status of \\\u003C= 0 or 1 and a life expectancy of \\>= 3 months.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)\n* Laboratory values meeting criteria outlined in the protocol\n* NSCLC - Advanced or metastatic progressed on standard of care (SOC) including chemotherapy and prior anti-PD-(L)1 antibody (separately or in combination). Actionable gene alterations are eligible if failed targeted therapeutic options.\n* HSNCC - Advanced\u002Fmetastatic progressed on platinum and PD-1\u002FPD-LI in recurrent or metastatic setting.\n* Micro Satellite Stable Colorectal Cancer (MSS-CRC) - Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, BRAFV600E or HER2, other targetable mutations targeted with locally approved therapy, TAS-102, Regorafenib and not MSI-h or MMR-deficient\n* Gastric and Gastroesophageal Junction adenocarcinoma (GEA) - Advanced\u002Fmetastatic progressed on at least 1 prior cytotoxic chemotherapeutic regimen and if applicable immune checkpoint inhibitor and\u002For HER2 therapy\n* High-Grade Serous Ovarian Cancer (HGSOC) - Progressed serous epithelial ovarian, fallopian tube or primary peritoneal cancer post SOC and not eligible for surgical resection. Platinum resistant cannot have \\>5 lines of prior therapy.\n* Pancreatic Adenocarcinoma (PDAC) - Advanced\u002Fmetastatic progressed after SOC. Includes adenosquamous carcinoma and post-Whipple.\n* Triple Negative Breast Cancer (TNBC) - Progressed after 1 or 2 systemic therapy that must have included taxane and treatment naïve to immunotherapy targeting T-cell co-stimulation\n\nExclusion Criteria:\n\n* Pancreatic Ductal Adenocarcinoma (PDAC) - Excludes neuroendocrine or acinar pancreatic carcinoma and participants with coagulopathy or at risk of or history of Deep vein thrombosis (DVT)\u002FPE\n* No major surgery within 28 days prior to dosing\n* No active autoimmune\u002Fimmunodeficiency disease with limited exceptions\n* Combination treatment excludes participants treated with anti-programmed cell death protein 1(PD-1)\u002FProgrammed cell death ligand 1 (PD-L1) who had immune mediated toxicity G3 or greater, interstitial lung disease, or hypersensitivity Combination treatment may also require no significant cardiac deficiencies and\u002For events\n* Pregnancy\n* Excluded medications include anticancer therapy within 5 half-live or 28 days (whichever is shorter), agent targeting Chemokine Receptor (CCR)8, live vaccines, immunosuppressive medication with limited exceptions",{"count":262,"type":21},694,[24],"Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. Head and Neck Squamous Cell Carcinoma (HNSCC) is a solid tumor, a disease in which cancer cells form in the tissues of the head and neck. The purpose of this study is to assess adverse events and pharmacokinetics of azirkitug as a monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan.\n\nBevacizumab is an approved product, while budigalimab, azirkitug, and telisotuzumab adizutecan are investigational drugs being developed for the treatment of NSCLC, HNSCC, and other solid tumors. Study doctors put the participants in groups called treatment arms. The maximum-tolerated dose (MTD)\u002Fmaximum administered dose (MAD) of azirkitug will be explored. Each treatment arm receives a different dose of azirkitug in monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. Approximately 694 adult participants will be enrolled in the study across approximately 80 sites worldwide.\n\nParticipants will receive azirkitug as a monotherapy or in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan as an Intravenous (IV) Infusion for an estimated treatment period of up to 2 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[266,29,267,268,269,270,271],"Non-Small Cell Lung Cancer","Micro Satellite Stable Colorectal Cancer","Gastric\u002FEsophageal Cancer","High-Grade Serous Ovarian Cancer","Pancreatic Cancer","Triple Negative Breast Cancer",[266,273,29,274,41,275,276,277,267,278,279,280,281,269,282,283,271,284,285,286],"NSCLC","HNSCC","Budigalimab","ABBV-181","ABBV-514","MSS-CRC, Gastric Cancer","Esophageal Cancer","GEA","GEJ","HGSOC","Pancreatic Cancer, PDAC","TNBC","Telisotuzumab Adizutecan","ABBV-400","2026-06-19",{"date":247,"type":52},{"date":290,"type":52},"2021-11-01",{"date":292,"type":21},"2027-07",{"name":294,"class":98},"AbbVie",48,{"id":297,"slug":4,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":306,"conditions":307,"keywords":315,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":336},"100551821","NCT06465069","A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","A Phase 1a\u002F1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors","NEXUS-01","Inclusion Criteria:\n\n* Have one of the following solid tumor cancers:\n\n  * Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer\n  * Cohort A2\u002FB1\u002FB2: urothelial carcinoma\n  * Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer\n* Prior Systemic Therapy Criteria:\n\n  * Cohort A1\u002FC: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies\n  * Cohort A2\u002FB1\u002FB2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.\n* Prior enfortumab vedotin specific requirements:\n\n  * Cohorts A1\u002FA2\u002FC: prior treatment with enfortumab vedotin is allowed, but not required\n  * Cohort B1: individual must be enfortumab vedotin naive in the advanced\u002Fmetastatic setting\n  * Cohort B2: individual must have received enfortumab vedotin in the metastatic\u002Fadvanced setting.\n* Measurability of disease\n\n  * Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)\n  * Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations\n\nExclusion Criteria:\n\n* Individual with known or suspected uncontrolled CNS metastases\n* Individual with uncontrolled hypercalcemia\n* Individual with uncontrolled diabetes\n* Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Recent thromboembolic event and\u002For clinically significant bleeding disorder\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms\n* History of pneumonitis\u002Finterstitial lung disease\n* History of Grade ≥3 skin toxicity when receiving enfortumab vedotin\n* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention",{"count":304,"type":21},420,[24],"The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.",[308,309,310,311,271,72,279,270,77,312,29,38,313,314],"Metastatic Solid Tumor","Recurrent Solid Tumor","Advanced Solid Tumor","Urinary Bladder Neoplasm","Cervical Cancer","Renal Pelvis Cancer","Bladder Cancer",[314,316,317,318,319,320,313,321,322,323,324,325,326],"Bladder Neoplasm","Bladder Urothelial Carcinoma","Urinary Bladder Cancer","Urinary Tract Cancer","Urothelial Neoplasms","Ureter Cancer","Nectin-4","Antibody Drug Conjugate (ADC)","Triple Negative Breast Cancer (TNBC)","Non-small Cell Lung Cancer (NSCLC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","2026-06-17",{"date":329,"type":52},"2026-06-18",{"date":331,"type":52},"2024-07-01",{"date":333,"type":21},"2027-05",{"name":335,"class":98},"Eli Lilly and Company",34,{"id":338,"slug":4,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":22,"phases":345,"briefSummary":346,"conditions":347,"keywords":353,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":371},"100631678","NCT07503808","A Study of IDE034 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors Types","An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Participant must be at least 18 years of age or the age of maturity per local regulations\n2. Participants with advanced recurrent or metastatic solid tumors expressing B7-H3 and PTK7 in the following indications: NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 \\[HER2\\] negative), CRC, and CRPC who have radiologically progressed or recurred on at least one line of therapy or is intolerant to additional effective standard therapies.\n3. Archival tissue sample for testing\n4. Measurable disease\n5. Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n6. Have adequate bone marrow and organ function.\n7. Able to comply with contraceptive\u002Fbarrier requirements\n\nExclusion Criteria:\n\n1. Known symptomatic brain metastases or leptomeningeal metastasis\n2. Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose.\n3. Have uncontrolled tumor-associated pain\n4. Have clinically significant cardiac abnormalities and\u002For cerebrovascular disease (stroke) within 6 months before the first dose\n5. Active uncontrolled infection\n6. Have history of interstitial pneumonitis, current noninfectious pneumonitis requiring steroid therapy; known or suspected interstitial pneumonitis as seen on screening imaging; other moderate to severe lung diseases seriously affecting respiratory function within 3 months before the first dose.\n7. Have history of severe infections within 4 weeks prior to the start of study treatment, including but not limited to bacteremia, severe pneumonia, or other serious infectious complications requiring hospitalization.\n8. Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening.\n9. Participants with known or suspected viral hepatitis\n10. Have history of active tuberculosis within 1 year before enrollment\n11. If participants had adverse reactions to previous antitumor treatment that have not recovered to guidelines of CTCAE Grade ≤ 1 and Grade 2 peripheral neurological symptoms\n12. Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 3 weeks before the first dose of IMP or other investigational products within 4 weeks of first dose of IMP\n13. Administration of any of the following\n\n    1. Current use or anticipated need for food or drugs that are known strong CYP3A4\u002F5 inhibitors or inducers\n    2. Have prior treatment with B7-H3 or PTK7 antibody-drug conjugate (ADC).\n    3. Have prior treatment with a topoisomerase I inhibitor (TOP1i), including an ADC with a TOP1i payload, within 6 months of first dose of IMP\n    4. Have received radiotherapy within 2 weeks prior to study entry\n    5. Have undergone major surgery or trauma within 4 weeks prior to study entry.\n    6. Have received live attenuated vaccine within 28 days prior to the first dose or are expected to receive live attenuated vaccine during the study treatment.\n    7. Female participants who are pregnant, lactating, or planning to become pregnant during the study period to 7 months after the last dose of IMP.\n    8. Are known to be allergic to any component or excipient of the IMP product or have a history of severe allergic reactions to other monoclonal antibody\u002Ffusion protein drugs.\n    9. Participants with complications in the eye including ulcers in the eye, and severe dry eye",{"count":344,"type":21},150,[24],"This is a Phase 1a\u002F1b, open-label, multicenter dose escalation and dose expansion clinical study to evaluate the safety, PK, immunogenicity and preliminary efficacy of IDE034 in participants with locally advanced\u002Fmetastatic solid tumor types that express B7-H3 and PTK7.",[152,348,29,349,350,351,352,271],"High Grade Serous Ovarian Cancer","Colorectal Cancer","Castration-resistant Prostate Cancer","Non Small Cell Lung Cancer","Endometrium Cancer",[152,354,355,29,274,356,284,349,357,350,358,72,273,359,282,360,361,362],"ESCC","Endometrial Cancer","Triple-negative Breast Cancer","CRC","CRPC","High-grade Serous Ovarian Cancer","Advanced, Metastic Solid Tumors","B7-H3 (CD276) and Protein Tyrosine Kinase 7 (PTK7)","IDE034","2026-06-16",{"date":329,"type":52},{"date":366,"type":52},"2026-02-24",{"date":368,"type":21},"2027-07-30",{"name":370,"class":98},"IDEAYA Biosciences",15,{"id":373,"slug":4,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":22,"phases":380,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":396},"100265421","NCT02734537","Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery","Phase II Randomized Trial of Radiotherapy With or Without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) With TP53 Sequencing","Inclusion Criteria:\n\n* PRE-REGISTRATION (STEP 0)\n* Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified \\[NOS\\]) of the head\u002Fneck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA (American Joint Committee on Cancer \\[AJCC\\] 8): T3-T4a, N0-3, M0 or T1-T2, N1-3, M0\n* Patient has undergone total resection of the primary tumor with curative intent\n\n  * NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the 8 week deadline to register the patient to Step 1 after surgery; full assay minimum turn-around time is 17-24 days\n* For oropharynx primary tumors, the patient must have negative human papillomavirus (HPV) status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC)\n* Patients with, per the operative and\u002For pathology report, positive margin(s) (tumor present at the cut or inked edge of the tumor) which is not superceded by an additional margin of tumor-negative tissue, nodal extracapsular extension, and\u002For gross residual disease after surgery are not eligible\n* A paraffin-embedded surgical tumor tissue specimen has been located is available for shipment to Foundation Medicine, Inc. following pre-registration\n\n  * NOTE: Complete the EA3132-specific FoundationOne requisition form\n* Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and\u002For non-melanomatous skin cancer; patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumor\n* Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease\n* Patients with recurrent disease or multiple primaries are ineligible\n* RANDOMIZATION (STEP 1)\n* NOTE: Patient must meet all eligibility criteria outlined in pre-registration; patient may not be randomized until site has been notified that the central determination of p53 mutation status of the surgical tumor tissue has been completed and site has been notified of assay completion\n* Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 8 weeks prior to randomization\n* The patient must have the following assessments done =\\\u003C 8 weeks prior to randomization:\n\n  * Examination by a head and neck surgeon\n  * Chest x-ray (or chest computed tomography \\[CT\\] scan or CT\u002Fpositron emission tomography \\[PET\\] of the chest or magnetic resonance imaging \\[MRI\\]) to rule out distant metastatic disease\n* Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1 within 2 weeks prior to randomization\n* Women must not be pregnant or breast-feeding; females of childbearing potential must have a blood or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and until 60 days from the last study treatment\n* Absolute neutrophil count \\>= 1,500\u002Fmm\\^3 within 4 weeks prior to randomization\n* Platelets \\>= 100,000\u002Fmm\\^3 within 4 weeks prior to randomization\n* Total bilirubin =\\\u003C the upper limit of normal (ULN) within 4 weeks prior to randomization\n* Calculated creatinine clearance must be \\> 60 ml\u002Fmin using the Cockcroft-Gault formula within 4 weeks prior to randomization\n* Patient must not have an intercurrent illness likely to interfere with protocol therapy",{"count":379,"type":21},189,[25],"This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.",[29,183,184,383,384,385,204,205,206,386,208,209,210,211,387,213],"Laryngeal Squamous Cell Carcinoma, Spindle Cell Variant","Lip and Oral Cavity Squamous Cell Carcinoma","p16INK4a Negative Oropharyngeal Squamous Cell Carcinoma","Stage III Oral Cavity Verrucous Carcinoma","Stage IVA Oral Cavity Verrucous Carcinoma",{"date":327,"type":52},{"date":390,"type":52},"2016-11-23",{"date":392,"type":21},"2027-12-31",{"name":394,"class":395},"ECOG-ACRIN Cancer Research Group","NETWORK",676,{"id":398,"slug":4,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":404,"briefSummary":405,"conditions":406,"keywords":409,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":60},"100641329","NCT07659678","CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Adult patient 18 years of age or older\n* Cohort 1: Newly diagnosed locally advanced T3-T4a, N0-3 and M0 squamous cell head and neck cancer scheduled to undergo standard of care surgery with or without neoadjuvant therapy OR Cohort 2: Suspected or biopsy proven recurrent\u002Fmetastatic squamous cell head and neck cancer scheduled to undergo first-line anti-PD1 therapy. HPV status does not need to be known and both HPV+ and HPV- subjects are eligible to enroll\n* Lesion size of at least 1.0 cm in longest dimension by conventional imaging.\n* Able to give informed consent\n* Not currently pregnant or nursing: Female subjects must be surgically sterile (has had a documented bilateral oophorectomy and\u002For documented hysterectomy), post- menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of Cu-DOTA-ECL1i is negative\n\nExclusion Criteria:\n\n* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 2 years\n* Unable to tolerate approximately 60 min (total time) of PET\u002FCT imaging",{"count":403,"type":21},90,[25],"This is a prospective study to evaluate the sensitivity and specificity of Cu-64 DOTA-ECL1i PET\u002FCT imaging to serve as a novel precision imaging tool for patients with head and neck squamous cell carcinoma (HNSCC).",[29,407,408],"Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent\u002FMetastatic (R\u002FM)","Head and Neck Squamous Cell Carcinoma HNSCC",[410,411,412,413],"Head and neck cancer","P16+ and P16-","PET","CCR2","2026-06-15",{"date":219,"type":52},{"date":417,"type":21},"2026-08-31",{"date":419,"type":21},"2032-03-31",{"name":421,"class":228},"Washington University School of Medicine",{"id":423,"slug":4,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":22,"phases":430,"briefSummary":425,"conditions":431,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":446},"100601788","NCT07115043","A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors","A Phase I\u002FII Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors","Inclusion criteria:\n\n* Participant ≥ 18 year\n* ECOG PS of 0 to 1\n* Provision of 'archival' tumor specimen\n* At least one measurable lesion according to RECIST v1.1,\n* Minimum life expectancy of 12 weeks\n* Adequate and stable cardiac function\n* Adequate bone marrow, liver and kidney function\n* Body weight ≥ 35 kg\n* Capable of giving signed informed consent\n\nModule 1 specific inclusion criteria:\n\n• Participants with locally advanced or metastatic select solid tumors (MM, Squamous cell carcinoma of skin, MCC, NSCLC, Head and neck squamous cell carcinoma, Gastric cancer\u002Fgastroesophaegeal junction cancer, RCC, HGSOC, Triple negative breast cancer) who have received adequate SoC\n\nModule 2 specific inclusion criteria:\n\n* Participants with Stage IV NSCLC Dose Escalation\u002FBackfills\n\n  1. Have received at least one prior regimen in metastatic setting (2L+ NSCLC). Participants with actionable tumor alterations should have received targeted therapy if locally available OR\n  2. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Dose Expansion\n\n  \u003C!-- -->\n\n  1. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Exclusion criteria:\n* Any evidence of:\n\nSevere or uncontrolled systemic diseases including respiratory, cardiac or tumor-related conditions\n\n* History or planned organ or allogeneic stem cell transplantation.\n* Active or prior documented autoimmune or inflammatory disorders, within the past 3 years\n* Any prior toxicities that led to permanent discontinuation of prior immunotherapy\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy\n* Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids\n* Acute untreated or symptomatic malignant spinal cord compression, or a history of leptomeningeal carcinomatosis.\n* Active uncontrolled or chronic infection of hepatitis B, hepatitis C\n* Prior history of Grade ≥ 3 non-infectious pneumonitis.\n* Participant requires chronic immunosuppressive therapy (including steroids \\> 10 mg prednisone\u002Fday or equivalent).\n* Receipt of live attenuated vaccine within 30 days.\n\nModule 2 specific exclusion criteria:\n\n* Previous treatment with anti-TIGIT therapy\n* 1L NSCLC participants with genetic alteration such as EGFR that has a targeted therapy in 1L as per local SoC",{"count":429,"type":21},60,[24,25],[432,72,433,434,435,271,29,436,437],"Melanoma","Squamous Cell Carcinoma (Skin)","Renal Cell Carcinoma","Merkel Cell Carcinoma","Gastric Cancer\u002FGastroesophageal Junction Cancer","High Grade Serous Ovarian Carcinoma","2026-06-10",{"date":440,"type":52},"2026-06-11",{"date":442,"type":52},"2025-07-29",{"date":444,"type":21},"2029-10-02",{"name":97,"class":98},13,{"id":448,"slug":4,"hasResults":11,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":454,"briefSummary":455,"conditions":456,"keywords":460,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":254},"100534468","NCT06239220","PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC","A Phase 2 Trial of PD-L1 t-haNK, NAI IL-15 Superagonist (Anktiva), and Cetuximab for Immunotherapy-treated Patients With Recurrent, Metastatic HNSCC (QUILT-505)","Inclusion Criteria:\n\n* Participants must have an existing histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) with evidence of recurrent, metastatic (R\u002FM) or locoregionally advanced, incurable or unresectable disease from any mucosal subsite including oral cavity, oropharynx, larynx, hypopharynx, nasal cavity, and the paranasal sinuses.\n* Participants must have at least one RECIST v1.1 measurable lesion, as defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) ≥ 1 cm with CT scans or MR imaging.\n* Must have had at least 1, but no more than 2, prior lines of prior systemic therapy for R\u002FM HNSCC; one of these lines should have included anti-PD-1\u002FL1 therapy.\n\n  * a.Platinum-based therapy as part of definitive\u002Fadjuvant or curative-intent treatment can count as 1 prior line of therapy if the subject progressed within 6 months of receiving therapy.\n  * b. At least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (2 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to NCI CTCAE v5 grade ≤1 (or tolerable grade 2) or back to baseline (except for alopecia or peripheral neuropathy).\n* Be ≥18 years of age on the day of signing informed consent.\n* Must provide prior documentation on tumor PD-L1 expression status and HPV status (for oropharyngeal cancer cases), if available from the medical record.\n* Have a performance status of 0 or 1 on the ECOG Performance Scale (see Appendix A).\n* Participants must have adequate organ and marrow function as defined below (within 14 days prior to study registration):\n\n  * a. ANC ≥1,000\u002FmcL\n  * b. Hemoglobin ≥9 g\u002FdL\n  * c. Platelets ≥100,000\u002FmcL\n  * d. Total bilirubin ≤ upper limit of normal (ULN)\n  * e. AST(SGOT)\u002FALT(SGPT) ≤2.5x institutional ULN (or ≤1.5x institutional ULN if concomitant with alkaline phosphatase \\>2.5x institutional ULN) or ≤5x ULN for those with liver metastases\n  * g. Serum creatinine ≤1.5x ULN or creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above 1.5x ULN\n* Baseline tumor measurements must be documented from imaging within 28 days prior to study registration.\n* Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 7 days of study registration. Female subjects should not become pregnant or nurse a baby during the study and through 120 days after the last dose of study drugs. Male subjects should use a condom as a contraceptive during the study and through 120 days after the last dose of study drugs.\n\nSperm donation is discouraged for up to 6 months after the last dose of study drug.\n\n-Be willing and able to provide written informed consent for the trial.\n\nExclusion Criteria\n\n* Have been previously treated with 3 or more lines of systemic therapy for R\u002FM HNSCC.\n* Have received radiation therapy (RT) within 10 days of starting protocol therapy.\n* Solid organ transplant (allograft) recipients.\n* Participant has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging and off systemic steroids for at least 3 weeks prior to study registration) and have no evidence of new or enlarging brain metastases.\n* A history of significant autoimmune disease as judged by the treating investigator and on active therapy including prednisone ≥10 mg daily dose equivalent of corticosteroids.\n* Uncontrolled intercurrent illness including but not limited to ongoing or active infection; evidence of symptomatic congestive heart failure, unstable angina pectoris, stroke, or ventricular arrhythmia within 6 months of enrollment.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions might include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Any known positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., hepatitis B surface antigen (HBsAg, Australia antigen) positive, or hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative). Patients with HIV are eligible if their plasma HIV viral load is undetectable at baseline on antiretroviral therapy.\n* Subjects who are pregnant, or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. Breastfeeding should be discontinued if the mother is treated on this protocol. Women who could potentially become pregnant while undergoing treatment on this protocol must be willing to use 2 methods of contraception.",{"count":7,"type":21},[25],"The purpose of this research study is to test the safety and efficacy of the combination of PD-L1 t-haNK (modified immune cells), NAI (a manufactured protein that stimulates the immune system), and cetuximab (a targeted antibody) in treating advanced head and neck cancer.\n\nThe names of the therapies involved in this study are:\n\n* PD-L1 t-haNK cell therapy (a NK cell therapy infusion)\n* NAI (a type of recombinant human superagonist)\n* Cetuximab (a type of antibody)",[28,29,457,458,459,242],"Metastatic Head and Neck Cancer","Recurrent Head and Neck Cancer","Metastatic Head-and-neck Squamous-cell Carcinoma",[28,29,457,458,459,242],{"date":440,"type":52},{"date":463,"type":52},"2024-02-16",{"date":465,"type":21},"2027-01-31",{"name":467,"class":228},"Glenn J. Hanna",{"id":469,"slug":4,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":474,"targetDuration":476,"studyType":477,"phases":4,"briefSummary":478,"conditions":479,"keywords":480,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":497},"100528650","NCT06163534","A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)","TEMPUS PHOENIX HNSCC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* ≥18 years of age\n* Willing and able to provide informed consent\n* Histologically- or cytologically-confirmed metastatic or unresectable, recurrent HNSCC unsuitable for local therapies\n* Intended for first line anti-PD1 or PDL1 monotherapy or combination therapy\n* Must submit tumor tissue sample representative of current disease per laboratory manual\n\nExclusion Criteria:\n\n* Non-squamous histologies (eg, nasopharynx or salivary gland)\n* Relapse or recurrence within 6 months of first line chemotherapy and \u002F or chemoradiotherapy\n* Tumors that are PD-L1 negative (CPS \\\u003C1)\n* Clinical evidence of an active second invasive malignancy within \\\u003C2 years of enrollment with the exception of stable prostate cancer on watchful waiting, in situ cervical cancer, in situ breast carcinoma or localized non-melanoma skin cancers\n* Unable to comply with study procedures (i.e., not willing or able to have additional blood samples collected)",{"count":475,"type":21},500,"1 Year","OBSERVATIONAL","The study is a prospective, longitudinal, non-interventional, multicenter study of participants with HNSCC who will have tissue and blood based molecular biomarker profiling during their standard of care treatment.",[29],[481,482,483,274,484,485,486,487,488],"Oncology","Biomarkers","Genomic Profiling","Cancer","Observational","Registry","Precision Medicine","NGS",{"date":490,"type":52},"2026-06-12",{"date":492,"type":52},"2024-08-01",{"date":494,"type":21},"2028-03-01",{"name":496,"class":98},"Tempus AI",30,{"id":499,"slug":4,"hasResults":11,"nctId":500,"briefTitle":501,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":506,"conditions":507,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":60},"100528561","NCT06162377","Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A \"Window of Opportunity\" Pilot Study.","Inclusion Criteria:\n\n* 18 years of age or older. Because no dosing or adverse event data are currently available on the use of methylnaltrexone in participants \\\u003C18 years of age, children are excluded from this study.\n* Histologically-confirmed oral cavity squamous cell carcinoma \\[(T1-T4, N (any)\\] that is amenable to curative-intent surgery\n* Able to receive the study drug for at least two weeks preoperatively\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n* The effects of methylnaltrexone on the developing human fetus are unknown. For this reason and because methylnaltrexone agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participants presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n  * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while her partner participates in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who are receiving any other investigational agents.\n* Non-English\u002FNon-Spanish speaking participants.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to methylnaltrexone or other agents used in the study.\n* Participants with uncontrolled intercurrent illness, including chronic kidney disease defined as a eGRF \\\u003C60 ml\u002Fmim, and liver disease defined as transaminitis \\> 2 folds from normal levels, cirrhosis and hyperbilirubinemia \\> 2 folds from normal levels\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Urgent or emergency surgery\n* Participants with known distant metastatic disease\n* Participants with primary brain tumors or brain metastases. Methylnaltrexone has poor penetration of the blood brain barrier and there is limited available data regarding the safety of the drug in participants with central nervous system tumors.\n* Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with methylnaltrexone, breastfeeding should be discontinued if the mother is treated with methylnaltrexone. These potential risks may also apply to other agents used in this study.\n* Peptic ulcer or intestinal perforation or colitis or other intestinal disorders such as Crohn's disease, diverticulitis, or Ogilvie's syndrome, intestinal obstruction or severe diarrhea because of risk of intestinal perforation.\n* Use of other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.",{"count":7,"type":21},[505],"PHASE4","To learn if OCSCC patients can be safely given methylnaltrexone for 2 weeks before surgery.",[29],"2026-06-09",{"date":438,"type":52},{"date":511,"type":52},"2024-01-10",{"date":513,"type":21},"2026-12-31",{"name":515,"class":228},"M.D. Anderson Cancer Center",{"id":517,"slug":4,"hasResults":11,"nctId":63,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":22,"phases":522,"briefSummary":523,"conditions":524,"keywords":525,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":528,"leadSponsor":529,"locationsCount":99},"100506685","A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and\u002For Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation","An Open-label, Phase 1, Multicenter Study to Evaluate the Safety and Preliminary Anti-tumor Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Subjects With Unresectable, Advanced and\u002For Metastatic Solid Tumors That Are Positive for the TP53 R175H Mutation","Key Inclusion Criteria\n\n* Subjects must be at least 18 years of age, at the time of signing the informed consent.\n* Subjects must be capable of giving signed informed consent.\n* Subject must be diagnosed with one of the histologies below:\n\n  * NSCLC\n  * Colorectal adenocarcinoma\n  * HNSCC\n  * Pancreatic adenocarcinoma\n  * Breast cancer\n  * Ovarian cancer\n  * Any other solid tumor\n* Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A\\*02:01 positive (at least 1 allele) as confirmed by an CLIA-accredited laboratory-based test.\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Subject has at least 1 measurable lesion per computed tomography (CT) scan or magnetic resonance imaging (MRI) per RECIST version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment\n* Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n* Per Investigator judgement, subject is likely to complete study visits and\u002For procedures per the protocol and comply with study requirements for study participation\n\nKey Exclusion Criteria\n\n* Any another primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of stroke or transient ischemic attack within the 12 months prior to enrollment.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or rIL-2; or known sensitivity or allergy to methotrexate, gentamicin, or other aminoglycosides.\n* Any form of primary immunodeficiency.\n* Live vaccine ≤ 4 weeks prior to enrollment or plans to have a live vaccine prior to planned lymphodepleting chemotherapy and\u002For NT-175 treatment.\n* Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)\n* Female of childbearing potential who is lactating or breast feeding at the time of enrollment.\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.",{"count":68,"type":21},[24],"Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant solid tumors.",[72,29,73,74,75,76,77],[80,81,82,83,84,85,86,75,77,89],{"date":438,"type":52},{"date":93,"type":52},{"date":95,"type":21},{"name":97,"class":98},{"id":531,"slug":4,"hasResults":11,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":22,"phases":538,"briefSummary":539,"conditions":540,"keywords":550,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":559},"100628495","NCT07462377","A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC","A First-in-Human, Open-label, Multicenter, Phase 1 Study of EPI-326 in Patients With Epidermal Growth Factor Receptor-Mutant Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Participant has a life expectancy \\> 12 weeks at Day 1.\n2. Participant has an ECOG performance status of 0-2.\n3. Participant has pathologically confirmed NSCLC or HNSCC.\n\n   o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion.\n4. Participant has locally advanced or metastatic NSCLC or HNSCC.\n5. Participant has adequate organ function\n\nExclusion Criteria:\n\n1. Participant has history of uncontrolled illness.\n2. Participant has symptomatic brain metastases.\n3. Participant has a diagnosis of any secondary malignancy within 3 years prior to enrollment, except for those patients treated with curative intent and no evidence of active disease.",{"count":537,"type":21},110,[24],"A phase 1 study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 administered to patients with locally advanced or metastatic HNSCC and to patients with any documented EGFR-mutant locally advanced or metastatic NSCLC.",[541,542,543,544,545,351,45,28,546,547,29,408,548,274,549],"Epidermal Growth Factor","Epidermal Growth Factor Receptor","Epidermal Growth Factor Receptor Gene Mutation","Non Small Cell","Non Small Cell Lung","Head and Neck Cancers","Head and Neck Squamous Cell Cancer","NSCLC (Non-small Cell Lung Cancer)","EGFR",[29,274,543,549,351,273],"2026-06-08",{"date":438,"type":52},{"date":554,"type":52},"2026-03-31",{"date":556,"type":21},"2029-07",{"name":558,"class":98},"EpiBiologics",6,{"id":561,"slug":4,"hasResults":11,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":22,"phases":568,"briefSummary":570,"conditions":571,"keywords":572,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":582},"100554214","NCT06496178","A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2)","A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared With Investigator's Choice Monotherapy Treatment in Previously Treated Patients With Incurable, Metastatic\u002FRecurrent Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Signed ICF before initiation of any study procedures.\n* Age ≥ 18 years at signing of ICF.\n* Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.\n* HNSCC participants progressed on or after anti-PD-1 therapy and platinum-containing therapy.\n* The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.\n* Documentation of p16 status (positive or negative) by local laboratory IHC for participants with primary oropharyngeal cancer.\n* A baseline new tumor sample unless the participant has an available tumor sample as an FFPE block with sufficient material.\n* Measurable disease as defined by RECIST v1.1 by radiologic methods.\n* ECOG PS of 0 or 1\n* Life expectancy ≥ 12 weeks, as per investigator\n* Adequate organ function (as per protocol)\n\nExclusion Criteria:\n\n* Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days prior to randomization.\n* Known leptomeningeal involvement\n* Any systemic anticancer therapy within 4 weeks prior to randomization.\n* Major surgery within 3 weeks or palliative radiotherapy within 2 weeks prior to randomization.\n* Persistent Grade \\>1 clinically significant toxicities related to prior antineoplastic therapies\n* History of hypersensitivity reaction to any of the excipients of treatment required for this study.\n* Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months of study entry\n* History of prior malignancies with the exception of localized cancer with curative resection (e.g. cervical intraepithelial neoplasia or nonmelanoma skin cancer)\n* Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy\n* Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders\n* Participants with known infectious diseases (as per protocol)\n* Pregnant or breastfeeding participants\n* Participant has a primary tumor site of nasopharynx (any histology).",{"count":567,"type":21},600,[569],"PHASE3","This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic\u002Frecurrent disease.",[29],[274],"2026-06-02",{"date":575,"type":52},"2026-06-03",{"date":577,"type":52},"2024-06-25",{"date":579,"type":21},"2029-03",{"name":581,"class":98},"Merus B.V.",216,{"id":584,"slug":4,"hasResults":11,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":591,"briefSummary":592,"conditions":593,"keywords":594,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":611},"100556447","NCT06525220","A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)","A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Recurrent or Metastatic PD-L1+ Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Signed ICF before initiation of any study procedures\n2. Age ≥ 18 years at signing of ICF\n3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent.\n4. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.\n5. HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1.\n6. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting\n7. A new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material\n8. Measurable disease per Investigator assessment as defined by RECIST v1.1 by radiologic methods\n9. ECOG Performance Status (PS) of 0-1\n10. Life expectancy ≥ 12 weeks, as per investigator assessment.\n11. Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan\n12. Adequate organ function as defined per protocol.\n13. HIV-positive patients are eligible only if the cluster of differentiation 4 (CD4+) count is ≥ 300\u002Fµl, viral load is undetectable, and the patient is currently receiving highly active antiretroviral therapy\n\nExclusion Criteria:\n\n1. Central nervous system metastases that are untreated or already treated but symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 21 days prior to randomization\n2. Known leptomeningeal involvement\n3. Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization\n4. Requirement for immunosuppressive medication\n5. Major surgery or radiotherapy within 3 weeks of randomization\n6. Clinically significant toxicities related to prior anticancer therapies that have not returned to ≤ Grade 1 or baseline except for Grade ≤2- myalgia, neuropathy, alopecia, and any prior therapy related endocrinopathies\n7. History of hypersensitivity reaction to any of the excipients of petosemtamab or pembrolizumab.\n8. Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment; or history of myocardial infarction within 6 months prior to randomization\n9. History of prior malignancies within the last 5 years, with the exception of excised local cancer\n10. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy\n11. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders\n12. Patients with known infectious diseases as per protocol.\n13. Pregnant or breastfeeding patients.\n14. The patient has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy of prednisone \\>10 mg\u002Fday or equivalent, or any other form of immunosuppressive therapy\n15. The patient has an active autoimmune disease that has required systemic immune suppressive treatment in the past 2 years; replacement therapy is not considered immune suppressive treatment\n16. The patient has had an allogeneic tissue\u002Fsolid organ transplant.\n17. Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply.",{"count":590,"type":21},700,[569],"This is a Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma.",[29],[274,595,596,597,598,599,600,601,602,603],"PD-L1+","Head and Neck cancer","Petosemtamab","Pembrolizumab","Liger","Oral Cavity","Oropharynx","Larynx","Hypopharynx","2026-06-01",{"date":573,"type":52},{"date":607,"type":52},"2024-09-25",{"date":609,"type":21},"2030-07",{"name":581,"class":98},205,{"id":613,"slug":4,"hasResults":11,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":22,"phases":620,"briefSummary":622,"conditions":623,"keywords":624,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":629,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":634,"locationsCount":60},"100507569","NCT05889091","A Study of the Use of Fat Flap Reconstruction to Reduce Neck Injury After Cancer Treatment","The Safety of a Buried, Free Fat Flap to Reduce Neck Morbidity Following Cancer Treatment: A Pilot Study","Inclusion Criteria:\n\n* Patients 18 years or older\n* Diagnosed with HNSCC (e.g., oropharyngeal, hypo\u002Flaryngeal SCC)\n* Primary treatment is with radiotherapy with or without chemotherapy\n* Salvage neck dissection is subsequently indicated for persistent or recurrent, nonmucosal disease in cervical lymph nodes\n* At the time of salvage neck dissection additional flap coverage is indicated to improve carotid coverage or replace missing skin\n\nExclusion Criteria:\n\n* Patients with primary site mucosal recurrence in addition to neck disease",{"count":619,"type":21},12,[621],"NA","The purpose of this study is to find out whether the fat ALT flap procedure is a safe and practical option for reducing neck morbidity in HNSCC patients following cancer treatment of the neck. Neck morbidity after radiation therapy and surgery includes difficulty swallowing, neck or shoulder pain, stiffness, swelling, or changes to the appearance of the treated area. In addition, the researchers will find out whether the study procedure is effective at reducing neck morbidity and improving quality of life after cancer treatment. The researchers will measure quality of life by having participants answer questionnaires.",[29],[625,626,627,628],"Free fat flap","Reconstruction","Quality of life","23-102",{"date":575,"type":52},{"date":631,"type":52},"2023-05-16",{"date":633,"type":21},"2027-05-16",{"name":635,"class":228},"Memorial Sloan Kettering Cancer Center",{"id":637,"slug":4,"hasResults":11,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":642,"enrollmentInfo":643,"targetDuration":4,"studyType":22,"phases":645,"briefSummary":646,"conditions":647,"keywords":653,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":660,"completionDateStruct":662,"leadSponsor":664,"locationsCount":4},"100639777","NCT07623369","A First-in-Human Study of HH160 in Patients With Advanced Solid Tumors","An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of HH160 in Patients With Advanced Solid Tumors","Key Inclusion Criteria\n\n1. Adults aged 18 to 75 years with signed informed consent.\n2. Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements.\n3. At least 1 measurable lesion per RECIST v1.1.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks.\n5. Adequate organ function based on protocol-specified laboratory criteria.\n\nKey Exclusion Criteria\n\n1. Active leptomeningeal disease or uncontrolled\u002Funtreated brain metastases.\n2. History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components.\n3. Other malignancy within 3 years prior to first dose, except specified curatively treated cancers.\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.\n5. Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage\u002Fhemoptysis.\n\nNOTE: Other eligibility criteria may apply.","75 Years",{"count":644,"type":21},56,[24],"This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.",[648,72,649,349,29,434,355,312,650,271,651,652],"Solid Tumor","Hepatocellular Carcinoma","Small-cell Lung Cancer","Urothelial Carcinoma","Gastroesophageal Adenocarcinoma",[654,655,72,273,649,656,349,357,280,29,434,657,355,312,650,271,284,651,652,77],"HH160","PD-1×CTLA-4×VEGF-A Antibody","HCC","RCC","2026-05-29",{"date":575,"type":52},{"date":661,"type":21},"2026-06",{"date":663,"type":21},"2028-08",{"name":665,"class":98},"Huahui Health",{"id":667,"slug":4,"hasResults":11,"nctId":668,"briefTitle":669,"officialTitle":670,"acronym":4,"eligibilityCriteria":671,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":672,"targetDuration":4,"studyType":22,"phases":673,"briefSummary":674,"conditions":675,"keywords":677,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":712,"startDateStruct":713,"completionDateStruct":714,"leadSponsor":716,"locationsCount":60},"100635428","NCT07552558","Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)","Phase I\u002FII Trial of Neoadjuvant Combination of Ficerafusp Alfa, Pembrolizumab, and SBRT for Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* Newly diagnosed histologically or cytologically confirmed locally advanced, OPC HPV-negative head and neck squamous cell carcinoma (OPSCC) or HNSCC arising from oral cavity, larynx, or hypopharynx.\n* Baseline resectable disease per the judgment of the treating surgical oncologist.\n* Clinical stage III, IVA, or IVB disease as defined using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC):\n\n  * T1-2, N1-3 or\n  * T3, any N or\n  * T4, any N\n* Documented tumor PD-L1 CPS ≥ 1 (by PD-L1 IHC pharmDx assay), determined locally.\n* Willing to provide blood and newly obtained core or excisional biopsy of tumor lesion pre-treatment and at the time of surgery for pathologic and correlative analyses.\n* Age 18 years or older at the time of informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 9 g\u002FdL (without PRBC transfusion in the prior 7 days)\n  * Total serum bilirubin ≤ 1.5 x IULN (except for subjects with documented diagnosis of Gilbert syndrome). For subjects with a documented diagnosis of Gilbert's syndrome, total bilirubin must be ≤ 3.0 × ULN, provided that direct bilirubin is within normal limits\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x IULN\n  * Creatinine clearance (measured or calculated via the Cockcroft-Gault equation or per institutional standards) ≥ 30 mL\u002Fmin\n  * PT\u002FINR or aPTT ≤ 1.5 x IULN (except for subjects receiving anticoagulant therapy)\n* The effects of pembrolizumab and ficerafusp alfa on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 120 days (women) or 90 days (men) after completion of study treatment.\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Currently receiving any other investigational agents.\n* Prior history of grade ≥ 2 intolerance or hypersensitivity reactions to other murine proteins, or the active substances of ficerafusp alfa, pembrolizumab, or any of their excipients.\n* At higher risk of bleeding, including known bleeding diathesis or current active major bleeding, or recent major bleeding episode (within 4 weeks prior to enrollment).\n* Any of the following within 6 months prior to starting study treatment: ST-elevation myocardial infarction, severe\u002Funstable angina, uncontrolled cardiac ventricular arrhythmia, coronary\u002Fperipheral artery bypass graft or stent, cerebrovascular accident\u002Fstroke less than 6 months prior to enrollment, or congestive heart failure. Subjects with deep vein thrombosis who are hemodynamically stable can enroll if they are on a stable dose of anticoagulants for at least 3 months.\n* Active autoimmune disease requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Active systemic infection requiring either hospitalization or parenteral anti-infective therapy within 2 weeks before first dose of study treatment.\n* Chronic hepatitis B virus (HBV) infection with active disease meeting the criteria for anti-HBV therapy but not on a suppressive antiviral therapy prior to initiation of study treatment. HBV testing not required in the absence of known history of infection. Note: Subjects who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. These subjects should remain on antiviral therapy throughout the study treatment period and follow local guidelines for HBV antiviral therapy post completion of study treatment.\n* Known history of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible provided they completed curative antiviral therapy at least 4 weeks prior to initiation of study treatment. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.\n* Known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies) with viral load \\>0 or CD4\\\u003C350. HIV testing is not required in the absence of known history of infection.\n* Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, except for transplants that do not require immunosuppression.\n* Known to be diagnosed and\u002For treated for any other additional malignancy within 2 years prior to randomization with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer defined as follows: Stage T1c or T2a with a Gleason score ≤ 6 and prostatic-specific antigen \\\u003C 10 ng\u002FmL either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study entry. Other exceptions may be considered with the PI's consultation. The time requirement for no malignancy for 2 years does not apply to the cancer for which a subject is enrolled in the study.\n* Any condition requiring systemic treatment with either corticosteroids (\\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids. Corticosteroid use as premedication for allergic reactions (e.g., intravenous contrast), or as a prophylactic management of AEs related to the therapies specified in the protocol is allowed. The use of physiologic doses of corticosteroids may be approved after consultation with the principle-Investigator.\n* Use of a live or live attenuated vaccine within 4 weeks prior to Screening. Note: Administration of killed, recombinant, or inactivated vaccines is allowed.\n* Pregnant or breastfeeding. People of childbearing potential must have a negative pregnancy test at screening and within 7 days of first dose of study treatment.",{"count":68,"type":21},[24,25],"The study is an open-label phase I\u002FII clinical trial. The study will enroll patients to receive neoadjuvant SBRT plus 1 or 2 doses of neoadjuvant pembrolizumab with concurrent ficerafusp alfa (4 doses) prior to definitive surgical resection for high-risk, locoregionally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC). Approximately 6 weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection followed by SOC adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. Adjuvant therapy is not part of this study and therefore is not dictated by study protocol.",[29,676],"HPV-Negative Squamous Cell Carcinoma",[678,679,680,681,682,683,684,685,686,687,688,689,410,690,691,692,693,694,695,696,697,698,274,699,700,701,702,703,704,705,706,707,708,709,710,711],"Shortened fractionation radiation","Immunotherapy","Curative treatment","Oral cavity cancer","Tongue cancer","Gum cancer","Jaw cancer","Palate cancer","Lip Cancer","Throat cancer","Mouth cancer","Voice box cancer","Oral cancer","Laryngeal cancer","Mandibular cancer","Alveolar ridge cancer","Hypopharyngeal cancer","Oropharyngeal cancer","OPSCC","OCC","OCSCC","Squamous cell carcinoma","Neoadjuvant therapy","Preoperative treatment","Stereotactic body radiotherapy","Radiation therapy","Targeted therapy","Keytruda","BCA101","PD-1 inhibitor","EGFR inhibitor","Checkpoint inhibitor","Locally advance","HP-negative",{"date":575,"type":52},{"date":132,"type":21},{"date":715,"type":21},"2033-08-31",{"name":421,"class":228},{"id":718,"slug":4,"hasResults":11,"nctId":719,"briefTitle":720,"officialTitle":721,"acronym":4,"eligibilityCriteria":722,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":723,"targetDuration":4,"studyType":22,"phases":725,"briefSummary":726,"conditions":727,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":735,"startDateStruct":736,"completionDateStruct":738,"leadSponsor":740,"locationsCount":559},"100591408","NCT06980038","Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer","A Phase 2 Window of Opportunity Trial of Neoadjuvant Agonistic Anti-CD40 Antibody CDX-1140 and Cemiplimab (REGN2810) in AJCC Stage III-IV Head and Neck Cancer Patients Prior to Surgery","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed American Joint Committee on Cancer (AJCC) stage III-IV T0-4, N0-3b, M0 mucosal head and neck squamous cell carcinoma (HNSCC) (oral cavity, oropharynx, larynx, hypopharynx, and nasal cavity) that is appropriate for surgical resection. Both previously untreated (primary) and recurrent (salvage) settings will be eligible. Tumors must be accessible to biopsy in clinic (patients with laryngeal, hypopharyngeal, nasal cavity and base of tongue tumors will have endoscopic biopsies)\n* For patients with oropharyngeal cancer, only p16-negative (non-human papillomavirus \\[HPV\\] related) patients will be eligible\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam\n* Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of cemiplimab (REGN2810) alone or in combination with CDX-1140 in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Hemoglobin (Hb) ≥ 7 g\u002FdL (transfusion allowed to bring Hb to this level)\n* Absolute neutrophil count ≥ 1,000\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) \u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* Creatinine ≤ 1.5 × institutional ULN OR glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Based on its mechanism of action, cemiplimab (REGN2810) can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1\u002FPD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Women of childbearing potential and men should use effective contraception during treatment with cemiplimab (REGN2810) and for 4 months after the last dose. The reproductive and developmental toxicity of CDX-1140 has not been evaluated. Women of childbearing potential and their partners who receive CDX-1140 must therefore take adequate contraceptive measures\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Active or documented history of autoimmune disease within 2 years before screening\n* Prior or planned allogeneic hematopoietic stem cell transplantation (HSCT)\n* History of organ transplant that requires use of immunosuppressive medications\n* Current or prior use of immunosuppressive medication within 14 days prior to the start of study drug administration. Immunosuppressants may interfere with study drug efficacy\n* Any previous treatment with a PD-1 or PD-L1 inhibitor, including cemiplimab (REGN2810). It is unclear how prior exposure to immunotherapy would impact future use of checkpoint inhibitors\n* Concurrent use of prednisone (10 mg or more)\n* Patients with new pulmonary infiltrates indicative of pneumonitis, history of (non-infectious) pneumonitis\u002Finterstitial lung disease, or current pneumonitis\u002Finterstitial lung disease, including grade 1 pneumonitis (i.e., asymptomatic, clinical or diagnostic observation only, intervention not indicated)\n* Another active malignancy for which the natural history or treatment has potential to interfere with the safety or efficacy assessment of the investigational regimen on this trial\n* Patients who have not recovered from AE due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents, such as concurrent chemotherapy, biologic, immunologic or hormonal therapy for cancer treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CDX-1140 or cemiplimab (REGN2810)\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because of the increased risk of immune-mediated rejection of the developing fetus with cemiplimab (REGN2810). Because of the potential for serious adverse reactions in breastfed children, women should not breastfeed during treatment with cemiplimab (REGN2810) and for at least 4 months after the last dose. These risks may also apply to CDX-1140",{"count":724,"type":21},44,[25],"This phase II trial compares the effectiveness of cemiplimab with CDX-1140 to cemiplimab without CDX-1140 prior to surgery in treating patients with stage III-IV head and neck cancer. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. CDX-1140 is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving cemiplimab with CDX-1140 versus cemiplimab alone before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed for patients with stage III-IV head and neck cancer.",[29,183,184,728,186,32,242,729,730,731,732,733,205,206,207,208,734,210,211,212,215,216],"Nasal Cavity Squamous Cell Carcinoma","Recurrent Hypopharyngeal Squamous Cell Carcinoma","Recurrent Laryngeal Squamous Cell Carcinoma","Recurrent Nasal Cavity Squamous Cell Carcinoma","Recurrent Oral Cavity Squamous Cell Carcinoma","Recurrent Oropharyngeal Squamous Cell Carcinoma","Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8",{"date":604,"type":52},{"date":737,"type":52},"2026-05-27",{"date":739,"type":21},"2027-11-24",{"name":58,"class":59},{"id":742,"slug":4,"hasResults":11,"nctId":743,"briefTitle":744,"officialTitle":745,"acronym":746,"eligibilityCriteria":747,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":748,"targetDuration":4,"studyType":22,"phases":749,"briefSummary":750,"conditions":751,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":753,"lastUpdatePostDateStruct":754,"startDateStruct":755,"completionDateStruct":757,"leadSponsor":759,"locationsCount":254},"100565893","NCT06648096","Afatinib in Patients With Fanconi Anemia (FA) and Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)","Phase Ib\u002FII Study to Investigate the Safety and Efficacy of Afatinib When Administered as Therapy in Fanconi Anemia Patients With Unresectable and \u002F or Metastatic Locoregionally Advanced Squamous Cell Carcinoma of the Oral Cavity, Oropharynx or Hypopharynx or Larynx.","AFAN","Inclusion Criteria:\n\n1. Written informed consent according to local guidelines, must be signed and dated by the participant and investigator prior to performing any protocol procedure.\n2. Patient is ≥ 18 years of age.\n3. Confirmed diagnosis of Fanconi anemia.\n4. Histologically or cytologically confirmed unresectable or locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, paranasal sinuses or salivary glands. Patients with distal metastasis (M1, American Joint Cancer Committee (AJCC) 8th ed.) are also eligible.\n5. Tumor not a candidate for resection prior to Afatinib due to technical inability to resect (tumor fixation \u002F invasion in the skull base, cervical vertebrae, nasopharynx or fixed lymph nodes) and \u002F or low surgical cure \\[T3-T4, N2-N3; , AJCC 8th ed.\\]).\n6. Patients must have at least 1 measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) as defined by RECIST v1.1.\n7. Previous anticancer treatment is allowed if it ends 6 weeks or 5 half-lives, whichever is shorter, before the expected date of start of the study treatment.\n8. Previous locoregional treatments such as radiotherapy are allowed.\n9. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C 2 at inclusion.\n10. Adequate organ and bone marrow functions, as defined below:\n\n    1. Neutrophils \\> 1000 cells \u002F microliter.\n    2. Platelets \\> 50,000 cells \u002F microliter.\n    3. Hemoglobin \\> 8 g \u002F dL\n    4. Creatinine \\\u003C 1.5 x upper limit normal (ULN) with clearance \\> 50 mL \u002F min.\n    5. Total bilirubin \\\u003C 1.5 x ULN. Note: patients with Gilbert's may be included with bilirubin \\\u003C2 x ULN.\n    6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.5 x ULN or \\\u003C 5 ULN if liver metastases are present.\n    7. International normalized ratio (INR) and prothrombin time (PT) \\\u003C1.5 x ULN.\n11. Female patients must either:\n\n    1. Be of non-childbearing potential:\n\n       Postmenopausal \\*(defined as at least 1 year without any menses) prior to screening , or Documented surgically sterile (e.g.hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal occlusion).\n\n       \\*Those who are amenorrheic due to an alternative medical cause are not considered postmenopausal and must follow the criteria for childbearing potential subjects.\n\n       OR\n    2. If of childbearing potential:\n\n    Agree not to try to become pregnant during the study and for at least 1 months after the final study drug administration, And have a negative urine or serum pregnancy test within 7 days prior to Day 1 (females with false positive results and documented verification of negative pregnancy status are eligible for participation), And if heterosexually active, agree to abstinence (if in line with the usual preferred lifestyle of the patient) or consistently use a condom plus 1 form of highly effective birth control per locally accepted standards starting at screening and throughout the study period and for at least 1 month after the final study drug administration.\n12. Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for at least 1 month after the final study drug administration.\n13. Male patients must not donate sperm starting at screening and throughout the study period, and for at least 1 month after the final study drug administration.\n14. Male patients with a partner with childbearing potential, or who is pregnant or breastfeeding must agree to abstinence or use a condom plus 1 form of highly effective birth control throughout the study period and for at least 1 month after the final study drug administration.\n15. Patient agrees not to participate in another interventional study while on treatment in the present study.\n\nExclusion Criteria:\n\n1. Patients who are candidates for surgery with curative intent are not eligible.\n2. Less than two weeks from surgical resection or other major surgical procedure at start of treatment. Planned surgery for other diseases.\n3. Previous treatment with EGFR small molecule inhibitors, EGFR inhibitory antibodies and \u002F or any investigational agents for the treatment of HNSCC within 4 weeks prior to the selection was not allowed.\n\n   Note: Previous treatment with chemotherapy and\u002For radiotherapy is allowed.\n4. Patient must have recovered from any previous treatment toxicity to Grade ≤ 2.\n5. Existence of any other intercurrent malignant disease is not allowed within the previous 2 years to inclusion.\n\n   Note: Patients with non melanoma skin cancer, curatively treated localized prostate cancer, or carcinoma in situ of any type (if complete resection was performed) are allowed.\n6. Active severe Severe infectious disease in the 4 weeks prior to the initiation of study treatment, including . Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.\n7. Patient has documented history of a cerebral vascular event (stroke or transient ischemic attack), or the following criteria for cardiac disease:\n\n   1. Myocardial infarction or unstable angina pectoris within 6 months of enrollment.\n   2. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.\n   3. New York Heart Association (NYHA) class III or greater congestive heart failure or left ventricular ejection fraction of \\\u003C 40%.\n8. Participants with QTc interval (corrected) \\> 470 msec at screening.\n9. History of interstitial lung disease requiring corticosteroids or pneumonitis.\n10. Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.\n11. Patient has known hypersensitivity to afatinib or to any excipient contained in the drug formulation.\n12. Female patients who are or intend to be pregnant or breastfeeding during their participation in the study or 1 month after the final study drug administration.\n13. Patients unable to comply with the protocol as determined by the investigator.\n14. The patient is currently participating in another clinical trial that would interfere with the radiological imaging schedule or any other determinations required in this protocol.\n15. Patient has other underlying medical conditions that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and follow-up.\n16. Patients with psychiatric disorders that may interfere with monitoring.",{"count":7,"type":21},[24,25],"This research study is a phase Ib\u002FII, single-arm, non-randomized, non-blind, multicenter study designed to determine whether Afatinib is effective and safe in patients with locoregionally unresectable and \u002F or metastatic HNSCC with Fanconi Anemia.\n\nThe main hypothesis, based on preclinical evidence, is that treatment with afatinib, an epithelial growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), could be an effective treatment option to control cancer for patients with FA - HNSCC.",[752,29],"Fanconi Anemia","2026-05-22",{"date":737,"type":52},{"date":756,"type":52},"2024-11-08",{"date":758,"type":21},"2028-12",{"name":760,"class":228},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",""]