[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sinonasal-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sinonasal-squamous-cell-carcinoma":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,53],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053397",false,"NCT07281417","Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma","Neoadjuvant Chemotherapy With or Without Cemiplimab (REGN2810) in Sinonasal Squamous Cell Carcinoma: A Randomized Phase 2 Study","Inclusion Criteria:\n\n* Patients must have histologically confirmed squamous cell carcinoma of sinonasal origin\n* Patients must have a T stage (T3, T4a, and select T4b) primary tumor according to American Joint Committee on Cancer (AJCC) 8th edition. 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* No evidence of metastatic disease determined by pre-treatment imaging. Metastatic disease to neck nodes is considered locally advanced and therefore allowable. Patients with N0 and N1-3 disease will be eligible\n* Known HPV status (i.e., HPV negative, p16 immunohistochemistry \\[IHC\\] positive, high risk \\[HR\\]-HPV in situ hybridization \\[ISH\\] positive) from testing performed prior to referral. HPV status data (e.g., date of test, type of test \\[p16 IHC or HR-HPV ISH\\] and testing result) must be collected during enrollment. Patients who do not have this information available for collection will not be enrolled on this study\n* Age ≥ 18 years\n\n  * Because no dosing or adverse event data are currently available on the use of cemiplimab (REGN2810) in combination with carboplatin and paclitaxel 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 ≥ 8 g\u002FdL (acceptable to reach via transfusion)\n* Absolute neutrophil count ≥ 1,500\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 glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* Creatinine clearance ≥ 40 mL\u002Fmin\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 a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\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. For this reason and because paclitaxel is a class D agent with the potential for teratogenic or abortifacient effects, women of childbearing potential (WCBP) and men should use highly effective contraception during treatment and for 6 months after the last dose of the study drugs. WCBP and men should avoid donating eggs\u002Fsperm during treatment and for 6 months after the last dose of the study drugs. Women should discontinue nursing during treatment and for 6 months after the last dose of the study drugs\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* Prior to enrollment, verification of payment coverage by insurance (or other payment) for neoadjuvant paclitaxel and carboplatin chemotherapy must be obtained\n\nExclusion Criteria:\n\n* Patients with unresectable disease\n* Patients presenting with T3 disease without the need for maxillectomy and\u002For orbital invasion requiring orbital dissection\u002Fresection\n* Patients who have had any previous systemic therapy to the index lesion in the past 12 months. This includes cemiplimab (REGN2810) and\u002For other immune modulating agents. Previous systemic therapy may alter or affect response\n* Patients who had palliative RT (\\\u003C 20 Gy) within 1 week prior to entering the study\n* Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imAEs)\n* History of pneumonitis within the last 5 years\n* Patients who have not recovered from adverse events (AEs) 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\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cemiplimab (REGN2810) or carboplatin and paclitaxel\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). Men and WCBP who are not prepared to use highly effective contraception during and for 6 months after completion of treatment are excluded from this study","ALL","18 Years",{"count":18,"type":19},108,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This phase II trial compares the effect of chemotherapy (carboplatin and paclitaxel) with versus without cemiplimab given before surgery (neoadjuvant) in patients with sinonasal squamous cell cancer. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. 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. The usual approach for patients with sinonasal squamous cell cancer is surgery followed by radiation therapy, with or without chemotherapy. Recently, some patients have also been treated with neoadjuvant chemotherapy before surgery. Adding cemiplimab to chemotherapy before surgery may be more effective at stopping the cancer from growing or spreading, compared to chemotherapy alone.",[25,26,27,28],"Sinonasal Squamous Cell Carcinoma","Stage III Sinonasal Cancer AJCC v8","Stage IVA Sinonasal Cancer AJCC v8","Stage IVB Sinonasal Cancer AJCC v8","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":19},"2026-11-24",{"date":37,"type":19},"2030-12-16",{"name":39,"class":40},"National Cancer Institute (NCI)","NIH",5,{"id":43,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":44,"targetDuration":4,"studyType":20,"phases":45,"briefSummary":23,"conditions":46,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":50,"completionDateStruct":51,"leadSponsor":52,"locationsCount":41},"100614578",{"count":18,"type":19},[22],[25,26,27,28],"2026-06-25",{"date":49,"type":33},"2026-06-26",{"date":35,"type":19},{"date":37,"type":19},{"name":39,"class":40},{"id":54,"slug":4,"hasResults":10,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":20,"phases":62,"briefSummary":63,"conditions":64,"keywords":73,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"100609025","NCT07209189","Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)","Neoadjuvant Chemotherapy and PD-1 Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)","(NeoScorch HN)","Inclusion:\n\n* Eligible subjects must have histologically confirmed, locoregionally advanced head and neck or sinonasal, nasolacrimal, or skull base tumors and meet HPV testing requirements as outlined.\n* HPV-independent HNSCC (cT2-cT4, N0-N3) with potential for organ preservation using response-adapted surgery.\n* HPV-associated HNSCC with radiographic extranodal extension (cT1-cT3 tonsil or lateralized base of tongue, N0-N1, up to 4 nodes with rENE).\n* Sinonasal\u002Fskull base tumors, including: sinonasal carcinomas, HPV-associated sinonasal cancer, sinonasal undifferentiated carcinoma (e.g., Isocitrate dehydrogenase 2 (IDH2) mutant), or neuroendocrine sinonasal tumors (e.g., olfactory neuroblastoma) (cT2-cT4, N0-N3).\n* HPV16 type only. Patients with non-HPV16 cancers are not eligible. If p16 immunohistohemistry (IHC) positivity is the only result available at enrollment, neoadjuvant therapy may start while HPV nucleic acid testing is pending. Patients found to be HPV non-16 must discontinue study participation.\n* At least 8 unstained 5-µm slides must be available. If unavailable, a new biopsy is required unless waived by the PI.\n* Appropriate candidates for curative-intent therapy.\n* American Joint Committee on Cancer (AJCC) 7th edition: Stage III-IV, excluding N2c or bulky N2b\u002Fc (N3 equivalent) and bulky T4 (≥30cc).\n* AJCC 8th edition: Stage I with N1, Stage II, or Stage III, excluding N2 disease, bulky nodal disease (N3 equivalent), or bulky T4 (≥30cc).\n* Surgical arm: Candidates must be operable based on upfront imaging\u002Fexam. Patients with Grade 1 rENE may proceed to surgery; Grade 2\u002F3 rENE are excluded.\n* Measurable disease per RECIST 1.1.\n* No prior systemic therapy, radiotherapy, or investigational agents for the current cancer.\n* No complete surgical resection within 8 weeks of enrollment (biopsy or excision with residual disease acceptable).\n* Eastern Cooperative Oncology Group (ECOG) 0-1 or Karnofsky ≥70%.\n* Platelets ≥100,000\u002FµL.\n* Absolute Neutrophil Count (ANC) ≥1,500\u002FµL.\n* Hemoglobin ≥9 g\u002FdL (without recent transfusion\u002FEPO).\n* Aspartate Aminotransferase (AST)\u002F Alanine Aminotransferase (ALT) \\\u003C2.5 × ULN.\n* Albumin ≥2.5 mg\u002FdL.\n* Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ULN if total \\>1.5 × ULN (Upper Limit of Normal).\n* Creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault or measured GFR).\n* International Normalized Ratio (INR)\u002F Prothrombin Time (PT) ≤1.5 × ULN (unless on anticoagulants; must be within therapeutic range).\n* Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN (unless on anticoagulants; must be within therapeutic range).\n* Must sign and understand a study-specific informed consent form.\n* Women of childbearing potential (WOCBP): Negative pregnancy test within 72 hours prior to first dose.\n* WOCBP must not be breastfeeding and must agree to use highly effective contraception during therapy and for 120 days after last dose.\n* Men: Must use adequate contraception during treatment and for 120 days after last dose; condom use required in addition to highly effective methods.\n* Azoospermic men and WOCBP not heterosexually active are exempt from contraception but must still undergo pregnancy testing.\n* Counseling on pregnancy prevention is mandatory.\n* Highly effective methods (\\\u003C1% failure rate with consistent use) must be used\n\nExclusion:\n\n* WOCBP with a positive urine pregnancy test within 72 hours before treatment allocation; if positive or inconclusive, a confirmatory serum pregnancy test is required.\n* Pregnant or breastfeeding, or planning to conceive or father a child during the study and for 120 days after the last dose.\n* Prior treatment with PD-1, PD-L1, PD-L2 inhibitors, or other agents targeting T-cell receptors (e.g., Cytotoxic T-lymphocyte antigen 4 (CTLA-4), OX40 (Tumor Necrosis Factor Receptor Superfamily Member 4), CD137).\n* Prior systemic anti-cancer therapy or radiotherapy for the current cancer. Surgery is allowed if adequately recovered from complications.\n* Radiotherapy within 2 weeks of study start. A 1-week washout is permitted for palliative, non-stereotactic radiation (≤2 weeks) to non-Central Nervous System (CNS), non-head and neck disease, provided there are no residual toxicities, no steroid requirement, and no history of radiation pneumonitis.\n* Live or live-attenuated vaccines within 30 days of first study dose (including live Corona Virus Disease (COVID-19) vaccines). Inactivated, Messenger ribonucleic acid (mRNA), and peptide vaccines are allowed.\n* Concurrent treatment with other investigational agents.\n* Participation in another investigational drug or device study within 4 weeks before first study dose, unless in follow-up phase only.\n* Diagnosis of immunodeficiency, or receiving chronic systemic steroids at doses \\>10 mg prednisone equivalent daily, or other immunosuppressive therapy within 7 days before study drug.\n* Active autoimmune disease requiring systemic treatment in the past 2 years. Physiologic replacement therapy (thyroxine, insulin, low-dose steroids for adrenal or pituitary insufficiency) is allowed.\n* History of severe hypersensitivity (≥Grade 3) to Toripalimab, its excipients, or other anti-PD-1 agents.\n* Additional active malignancy requiring treatment within 2 years, except basal\u002Fsquamous cell skin cancers, in situ cancers, low-grade tumors unlikely to affect survival within 3 years, or cancers treated with curative therapy.\n* Active CNS metastases or carcinomatous meningitis. Intracranial extension of the primary tumor is allowed. Patients with previously treated brain metastases may enroll if radiologically stable ≥4 weeks, clinically stable, and off steroids ≥14 days before study drug.\n* History of pneumonitis or interstitial lung disease requiring steroids, or current pneumonitis\u002FInterstitial Lung Disease (ILD).\n* Active infection requiring systemic therapy.\n* Known HIV infection.\n* Known active Hepatitis B (HBsAg positive) or active Hepatitis C (HCV RNA positive). Patients with cleared or eradicated Hepatitis B (HBV) or HCV are eligible.\n* Any condition, therapy, or abnormality that could confound study results, interfere with participation, or be judged by the investigator as not in the participant's best interest.\n* Known psychiatric illness or substance abuse that could interfere with study compliance. Stable chronic managed disorders are acceptable.\n* History of allogeneic tissue or solid organ transplant.\n* Significant cardiovascular disease, including congestive heart failure (NYHA Class III or IV), unstable angina, serious uncontrolled arrhythmia, myocardial infarction within 6 months, or prior myocarditis.",{"count":61,"type":19},75,[22],"The NeoScorch HN study is a single institution multisite phase II trial including 3 cohorts of 25 patients each for patients with newly diagnosed locoregionally advanced, histologically confirmed, head and neck cancer eligible for curative-intent treatment, who will receive neo-adjuvant chemoimmunotherapy-based treatment as well as standard of care adjuvant treatment. The three cohorts include three different aspects of surgical de-escalation in head and neck cancer. The first cohort includes human papillomavirus independent (HPV-) squamous cell carcinoma of the head and neck. The second cohort includes HPV-associated head and neck cancer with radiographic evidence of extranodal extension in neck lymphadenopathy. The third cohort specifically includes malignancies of the sinonasal cavity and skull base which have a propensity for invasion of the orbit, skull base, and maxilla. Surgical treatment of all three of these cohorts has significant morbidity including swallowing, speech, and vision among others.",[65,66,67,68,69,25,70,71,72],"Head and Neck Cancer","Squamous Cell Carcinoma","Oral Cavity Cancer","Oropharyngeal Cancer","Laryngeal Cancer","HPV (Human Papillomavirus)-Associated Carcinoma","Skull Base Tumors","HPV 16 Positive Oropharyngeal Tumors (OPC)",[74,75,76,77,78,79],"head and neck cancer","oral cancer","oropharyngeal cancer","laryngeal cancer","HPV associated","squamous cell carcinoma","2026-04-21",{"date":82,"type":33},"2026-04-23",{"date":84,"type":33},"2026-02-18",{"date":86,"type":19},"2030-12-01",{"name":88,"class":89},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",1,""]