[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoplasms-by-site\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoplasms-by-site":668},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,54,83,163,219,253,274,294,313,347,376,432,467,500,536,581,610,643],{"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":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100610070",false,"NCT07222800","Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer","AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER","Inclusion Criteria:\n\n* Histological or cytological confirmed colorectal adenocarcinoma.\n* Evidence of Stage IV metastatic disease.\n* No prior systemic therapy for metastatic disease.\n* Eastern Cooperative Oncology Group performance status (ECOG) 0-1\n* At least one measurable lesion according to RECIST 1.1 per Investigator assessment.\n* Adequate hepatic, liver, and renal function\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Locally confirmed BRAF V600E mutation\n* Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer\n* Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression\n* Clinically significant risk of hemorrhage or fistula\n* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n* Any Grade ≥3 bleeding\u002Fhemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events\n* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years\n* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis","ALL","18 Years",{"count":18,"type":19},800,"ESTIMATED","INTERVENTIONAL",[22],"PHASE3","The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have colorectal cancer that has spread to other parts of your body.\n* Be in good enough health to receive study treatment.\n* Should not be pregnant before starting treatment.\n\nParticipants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects.\n\nThe medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment.\n\n* The study is expected to last approximately 33 months for each participant.\n* Participants will have regular visits to the study site for treatment, health checks, and tests.\n* After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects.\n* Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.",[25,26,27,28,29,30,31,32,33,34],"Intestinal Neoplasms","Gastrointestinal Neoplasms","Digestive System Neoplasms","Neoplasms by Site","Digestive System Diseases","Gastrointestinal Diseases","Colonic Diseases","Intestinal Diseases","Rectal Diseases","Colorectal Neoplasms",[36,37,38,39,40],"mCRC","metastatic disease","first-line","metastatic colorectal cancer","colon cancer","RECRUITING","2026-06-03",{"date":44,"type":45},"2026-06-04","ACTUAL",{"date":47,"type":45},"2025-12-11",{"date":49,"type":19},"2031-08-01",{"name":51,"class":52},"Pfizer","INDUSTRY",228,{"id":55,"slug":4,"hasResults":10,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":20,"phases":63,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100468924","NCT05386108","Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+\u002FHER-2- Breast Cancer","An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer","ELECTRA","Inclusion Criteria:\n\n1. Participant has the signed informed consent form before any study-related activities according to local guidelines.\n2. Women or men aged ≥18 years, at the time of informed consent signature.\n\n   * Female participants may be either postmenopausal or pre\u002Fperimenopausal. Postmenopausal status is defined by:\n\n     1. Age ≥60 years\n     2. Age \\\u003C60 years and amenorrhea for 12 or more months without an alternative cause) and follicle stimulating hormone and estradiol in postmenopausal ranges per local reference ranges\n     3. Documentation of prior bilateral oophorectomy, at least 1 month before first dose of trial therapy).\n   * Pre-menopausal \u002F peri-menopausal women and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 3-4 weeks before the start of trial therapy and is planning to continue LHRH during the study.\n3. Participant must have ER-positive, HER-2 negative tumor status as confirmed by local laboratory testing in the following manner:\n\n   * Documentation of ER positive tumor with ≥ 1% staining by immunohistochemistry (IHC) as defined in the 2010 or 2020 American Society for Clinical Oncology (ASCO) recommendations for ER testing, with or without progesterone receptor (PGR) positivity\n   * HER-2 negative tumor with an IHC result of 0 or 1+ for cellular membrane protein expression or an in situ hybridization negative result as defined in the 2013 or 2018 ASCO recommendations for HER-2 testing\n4. In Phase 2, participants must have at least one active and measurable brain metastasis per RECIST version 1.1.\n\n   * Any of the following qualifies brain metastases as active:\n\n     1. Newly diagnosed brain metastasis in participants who never received prior central nervous system (CNS)-directed therapy.\n     2. Newly diagnosed brain metastasis outside any area that was previously subjected to CNS-directed therapy.\n     3. Brain metastases demonstrating unequivocal progression in the opinion of the treating investigator in an area that has previously been subjected to CNS-directed therapy.\n   * For lesions, including brain metastases, to qualify as measurable, and possibly be selected as target lesions, per RECIST version 1.1, the longest diameter must be ≥10 millimeters \\[mm\\] by computed tomography \\[CT\\] or magnetic resonance imaging \\[MRI\\]).\n   * In Phase 1b, the presence of brain metastases is allowed but not required for eligibility, in this case, at least 1 measurable lesion outside the brain is required.\n5. Participants receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 7 days prior to baseline and not receiving doses higher than 4 mg of dexamethasone per day or equivalent.\n6. Participants have experienced no more than one seizure within 4 weeks prior to starting trial therapy.\n7. Participants' prior therapy received in the metastatic setting includes:\n\n   * At least one endocrine therapy\n   * Up to two chemotherapy regimens\n   * Up to two lines of prior cyclin-dependent kinase (CDK) 4\u002F6 inhibitor, not including abemaciclib\n\n   Note 1: Toxicity from prior therapy must be resolved to NCI CTCAE version 5.0 Grade ≤1, with the exception of alopecia and peripheral sensory neuropathy (Grade ≤2).\n\n   Note 2: Chemotherapy refers to not targeted cytotoxic agents (for example, alkylating agents, taxanes, nucleotide analogs, platinum-based drugs, vinca alkaloids, etc) and antibody drug conjugates (ADCs). Targeted therapies (for example, kinase inhibitors) are not considered chemotherapy for eligibility purposes. Not targeted cytotoxic agents administered for less than 1 cycle will not be counted as a prior chemotherapy regimen.\n8. Participant has documented intracranial and\u002For extracranial radiological progression or recurrence while on or after the most recent therapy.\n9. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2\n10. Participant has a life expectancy ≥ 12 weeks.\n11. Participant has adequate bone marrow and organ function, as defined by the following laboratory values:\n\n    1. Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002Fliter (L)\n    2. Platelets ≥100 × 10\\^9\u002FL\n    3. Hemoglobin ≥9.0 grams (g)\u002Fdeciliter (dL)\n    4. Potassium, sodium, calcium (corrected for serum albumin) and magnesium CTCAE Grade ≤1 (if screening assessments are abnormal, these assessments may be repeated up to 2 times; participants may receive appropriate supplementation or treatment prior to reassessment)\n    5. Creatinine clearance (per Cockcroft-Gault formula) ≥50 mL\u002Fminute\n    6. Serum albumin ≥3.0 g\u002FdL (≥30 g\u002FL)\n    7. Liver function tests:\n\n       In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN). If the participant has liver metastases, ALT and AST ≤5.0 × ULN.\n    8. Total serum bilirubin \\\u003C1.5 × ULN except for participants with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN\n12. The participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n1. Immediate CNS-specific treatment is likely to be required, per the treating physician's assessment.\n2. Participant has imminent organ failure and\u002For visceral crisis.\n3. Participant has leptomeningeal metastases, defined as having positive cerebrospinal fluid (CSF) cytology or unequivocal radiologic and clinical evidence of leptomeningeal involvement. Note: Discrete dural metastases are permitted.\n4. Breast cancer treatment-naïve participants (that is, not having received any systemic therapy) in the advanced\u002Fmetastatic setting.\n5. History of pulmonary embolism (PE), cardiovascular accident (CVA), myocardial infarction (MI) in the past 6 months from screening visit.\n6. Prior therapy with abemaciclib in the metastatic setting. Note: Use of abemaciclib in the adjuvant setting is allowed if the last treatment administration was more than 12 months prior to first recurrence.\n7. Prior therapy with elacestrant or other investigational selective estrogen receptor degraders (SERDs), or investigational alike agents such as selective estrogen receptor modulators (SERMs), selective estrogen receptor covalent antagonists (SERCANs), complete estrogen receptor antagonists (CERANs), and proteolysistargeting chimeras (PROTACs) in the metastatic setting.\n8. Participant has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or second primary breast cancer; and any other malignancy that is considered in complete remission by the Investigator(s) that is approved by the Medical Monitor.\n9. Currently participating in another breast cancer intervention clinical study. Participants who are being followed for overall survival for another clinical trial with no therapy and study intervention are allowed after the washout period for any prior therapy.\n10. Prior anti-cancer or investigational drug treatment within the following windows:\n\n    * Fulvestrant treatment (last injection) \\\u003C42 days before first dose of study drug\n    * Any other endocrine therapy \\\u003C14 days before first dose of study drug. Note: LHRH agonists should not be counted as endocrine therapy.\n    * Chemotherapy or other anti-cancer therapy \\\u003C14 days before first dose of study drug\n    * Any investigational anti-cancer drug therapy within \\\u003C28 days or \\\u003C5 half lives, whichever is shorter\n    * Bisphosphonates or receptor activator of nuclear factor-κB ligand (RANKL) inhibitors initiated, or dose changed \\\u003C1 month prior to first dose of study drug according to institutional guidelines.\n11. Radiation therapy (including CNS directed) within 7 days before the first dose of study drug or without a full recovery from radiotherapy acute effects.\n12. Uncontrolled significant active infections\n\n    * Participants with hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV) infection must have undetectable viral load (or detected below the lower limit of quantification) during screening\n    * Participants known to be human immunodeficiency virus positive (HIV+) are allowed as long as they have undetectable viral load (viral suppression) at baseline.\n13. Major surgery within 4 weeks of starting trial therapy.\n14. Inability to take oral medication, or history of malabsorption syndrome or any other uncontrolled gastrointestinal condition that may significantly alter the absorption of study drugs.\n15. Females of childbearing potential who do not agree to use a highly effective non-hormonal method of contraception and to abstain from donating ova within 28 days of the first dose of study treatment through 120 days after the last dose of study treatment. Highly effective non-hormonal method of contraception includes any of the following:\n\n    1. Intrauterine device (non-hormonal)\n    2. Sexual abstinence\n    3. Bilateral tubal occlusion\u002Fligation\n    4. Have a vasectomized partner with confirmed azoospermia.\n16. Male participants (including males after a vasectomy) with a pregnant or non-pregnant female of childbearing potential partner who do not agree to use a highly effective barrier contraception method (condoms) within 28 days of the first dose of study treatment until 120 days of the last dose of study treatment. And male participants who do not agree to abstain from freezing or donating sperm within the same period. In addition, female partners of childbearing potential, of male participants (who has not undergone vasectomy) must use highly effective methods of contraception.\n17. Females who are pregnant or breastfeeding. Females should not get pregnant during study treatment and for 120 days after last dose of study treatment. Females should not breastfeed during administration of elacestrant and for 1 week after receiving the last dose.\n18. Known intolerance to either study drug or any of their excipients.\n19. Participants currently receiving or received any of the following medications prior to first dose of trial therapy:\n\n    1. Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 (including foods and herbal preparations) within 14 days or \\\u003C5 half-lives, whichever is shorter)\n    2. Herbal preparations\u002Fmedications (which are not strong or moderate inducers or inhibitors of CYP3A4). These include, but are not limited to, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 7 days prior to initiating trial therapy\n    3. Vaccination, including but not limited to vaccination against coronavirus disease-19 (COVID-19), during the 7 days prior to randomization.\n20. Any severe medical or psychiatric condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.",{"count":62,"type":19},73,[64,65],"PHASE1","PHASE2","This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.",[68,69,28,70,71,72,73,74],"Breast Neoplasms","Brain Neoplasms","Neoplasms","Breast Diseases","Central Nervous System Neoplasms","Brain Diseases","Central Nervous System Diseases",{"date":44,"type":45},{"date":77,"type":45},"2022-08-31",{"date":79,"type":19},"2026-12",{"name":81,"class":52},"Stemline Therapeutics, Inc.",86,{"id":84,"slug":4,"hasResults":10,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":10,"sex":15,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":20,"phases":93,"briefSummary":94,"conditions":95,"keywords":125,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":162},"100355699","NCT03911388","HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors","Phase 1 Trial of Engineered HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors","Inclusion Criteria:\n\n* Age ≥ 36 months and \\\u003C 22 years\n* Pathologically proven malignant cerebellar brain tumor (including medulloblastoma, glioblastoma multiforme, giant cell glioblastoma, anaplastic astrocytoma, primitive neuroectodermal tumor, ependymoma, atypical teratoid\u002Frhabdoid tumor, germ cell tumor, or other high-grade malignant tumor) which is progressive or recurrent despite standard care including surgery, radiotherapy, and\u002For chemotherapy. A pathologically proven secondary malignant cerebellar tumor without curative treatment options is eligible.\n* Lesion must be ≥ 1.0 cm ≤ 3.0 cm in diameter and surgically accessible as determined by MRI. Larger tumors may be surgically debulked and treated if ≤ 3.0 cm after debulking\n* Patients must have fully recovered from acute treatment related toxicities of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study.\n* Myelosuppressive chemotherapy: patients must have received their last dose at least 3 weeks prior (or at least 6 weeks if nitrosurea)\n* Investigational\u002FBiologic agents: patients must have recovered from any acute toxicities potentially related to the agent and received last dose ≥ 7 days prior to entering this study (this period must be extended beyond the time during which adverse events are known to occur for agents with known adverse events ≥ 7 days). For viral therapy, patients must have received viral therapy ≥ 3 months prior to study entry and have recovered from all acute toxicities potentially related to the agent.\n* Monoclonal antibodies: The patient must have received last dose ≥ 21 days prior.\n* Radiation: Patients must have received their last fraction of craniospinal radiation (\\>24 Gy) or total body irradiation ≥ 3 months prior to study entry. Patients must have received focal radiation to symptomatic metastatic sites or local palliative radiation ≥ 28 days prior to study entry.\n* Autologous bone marrow transplant: Patients must be ≥ 3 months since transplant prior to study entry.\n* Normal hematological, renal and liver function (absolute neutrophil count \\> 1000\u002Fmm3, platelets \\> 100,000\u002Fmm3, prothrombin time (PT) or partial thromboplastin time (PTT) \\\u003C 1.3 x control, creatinine within normal institutional limits OR creatinine clearance \\>60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal, total bilirubin \\\u003C 1.5 mg\u002Fdl, transaminases \\\u003C 3 times above the upper limits of the institutional norm)\n* Patients \\\u003C 16 years, Modified Lansky performance score ≥ 60; patients ≥ 16 years, Karnofsky performance score ≥ 60\n* Patient life expectancy must be at least 8 weeks\n* Written informed consent in accordance with institutional and FDA guidelines must be obtained from patient or legal guardian\n\nExclusion Criteria:\n\n* Any treatment outside the allowable guidelines outlined in section 5.1.\n* Diffuse, widespread, abnormal tumor pattern involving 3 or more lobes of the brain\n* Acute infection, granulocytopenia or medical condition precluding surgery\n* Pregnant or lactating females\n* Diagnosis of encephalitis or CNS infection \\\u003C 3 months prior, or receiving ongoing treatment for encephalitis, CNS infection or multiple sclerosis\n* Tumor involvement which would require ventricular or brainstem inoculation or would require access through a ventricle in order to deliver treatment\n* Required steroid increase within 1 week prior to G207 inoculation or patients requiring \\>2 mg of dexamethasone daily\n* Known HIV seropositivity\n* Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, gancyclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except dexamethasone or prednisone).\n* Other current malignancy\n* Concurrent anticancer or investigational drug","3 Years","21 Years",{"count":92,"type":19},24,[64],"This study is a clinical trial to determine the safety of inoculating G207 (an experimental virus therapy) into a recurrent or refractory cerebellar brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication, tumor cell killing, and an anti-tumor immune response, will also be tested.\n\nFunding Source- FDA OOPD",[96,97,98,70,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,28,73,74,118,119,120,121,122,123,124],"Neoplasms, Brain","Glioblastoma Multiforme","Glioblastoma of Cerebellum","Astrocytoma","Astrocytoma, Cerebellar","Neuroectodermal Tumors","Neuroectodermal Tumors, Primitive","Cerebellar PNET, Childhood","Cerebellar Neoplasms","Cerebellar Neoplasms, Primary","Cerebellar Neoplasm, Malignant","Cerebellar Neoplasm Malignant Primary","Neoplasm Metastases","Neoplasm Malignant","Neoplasms, Neuroepithelial","Neoplasms, Germ Cell and Embryonal","Neoplasms by Histologic Type","Neoplasms, Glandular and Epithelial","Neoplasms, Nerve Tissue","Central Nervous System Neoplasms, Primary","Central Nervous System Neoplasms, Malignant","Nervous System Neoplasms","Nervous System Diseases","Medulloblastoma Recurrent","HSV","Virus","Pediatric Brain Tumor","Nervous System Cancer","Primitive Neuroectodermal Tumor (PNET) of Cerebellum",[126,127,97,128,129,130,131,132,133,134,135,136,137,138,139,140,70,141,142,143,144,145,146,147,148,121,120,149,150,151],"Brain Tumor, Recurrent","Glioma","Gliosarcoma","Medulloblastoma","Anaplastic Astrocytoma","Oligodendroglioma","Rhabdoid Tumor","Ependymoma","Germ Cell Tumor","Choroid Plexus Carcinoma","Cerebral Primitive Neuroectodermal Tumor","Giant Cell Glioblastoma","Atypical teratoid\u002Frhabdoid tumor","Secondary Malignant Cerebellar Tumor","Embryonal Tumor","Oncolytic Virus Therapy","Virotherapy, Oncolytic","Immunotherapy","Central Nervous System Agents","Antineoplastic Agents","Pediatric","Pediatrics","Oncolytic","Herpes Virus","G207","Oncolytic Herpes Virus","2026-05-13",{"date":154,"type":45},"2026-05-15",{"date":156,"type":45},"2019-09-12",{"date":158,"type":19},"2027-09-01",{"name":160,"class":161},"M.D. Anderson Cancer Center","OTHER",3,{"id":164,"slug":4,"hasResults":10,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":10,"sex":15,"minAge":170,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":20,"phases":173,"briefSummary":174,"conditions":175,"keywords":191,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":218},"100626796","NCT07440290","DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and TYA Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 07 (DABRAFENIB AND TRAMETINIB) OUTLINED BELOW\\* \\*When dabrafenib- and trametinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the dabrafenib- and trametinib-specific criteria will take precedence.\n\nInclusion criteria:\n\nA. Confirmed diagnosis of a malignancy harbouring an oncogenic alteration in BRAF V600, including Langerhans cell histiocytosis, using an analytically validated next-generation sequencing method.\n\nB. Patients ≥1 year old and ≥8 kg in body weight.\n\nC. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n• Have a negative serum or urine pregnancy test before enrolment and;\n\n• Agree to use one form of a non-hormonal highly effective contraception method (a method that can achieve a failure rate of \\\u003C1% when used consistently and correctly; the requirement for non-hormonal method is because dabrafenib may decrease the efficacy of oral or any systemic hormonal contraceptives), such as: i. intrauterine device (IUD), ii. bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking trial treatment), iii. vasectomised partner, iv. total sexual abstinence. Effective from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nPatients who are breastfeeding must be willing to discontinue breastfeeding from the start of treatment, throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks after the last administration of dabrafenib and 16 weeks after the last administration of trametinib (whichever is later):\n\n* Agree to take measures not to father children by using a barrier method of contraception (male condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male partners with partners who are women of childbearing potential should also be advised of the benefit for their partner of using a highly effective method of contraception, such as:\n\n  i. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\]), ii. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), iii. IUD, iv. intrauterine hormone-releasing system (IUS), v. bilateral tubal occlusion, vi. total sexual abstinence.\n* Male patients with pregnant or breastfeeding partners must be advised to use barrier method contraception (male condom) to prevent drug exposure of the foetus or neonate, even if vasectomised.\n* Male patients must refrain from donating sperm for the same period.\n\nE. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nF. Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility\n\nExclusion criteria:\n\nA. Diagnosis of one of the following BRAF V600E mutation-positive cancers:\n\n* Colorectal cancer in adult (≥18 years) patients;\n* Unresectable or metastatic melanoma in adult (≥18 years) patients;\n* Advanced non-small cell lung cancer in adult (≥18 years) patients;\n* Gliomas harbouring a BRAF V600E mutation in paediatric (1 to \\\u003C16 years) or TYA (16 to \\\u003C18 years) patients.\n\nB. Previous treatment with dabrafenib and trametinib in combination (or other BRAF and MEK inhibitors in combination) for the current indication.\n\nC. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for two weeks following their last dose of dabrafenib or 16 weeks following their last dose of trametinib, whichever is later.\n\nD. Known hypersensitivity to dabrafenib or trametinib or any of the excipients. See the current relevant SmPCs (UK) for the full lists.\n\nE. Patients with a history of retinal vein occlusion.\n\nF. Any impairment of gastrointestinal (GI) function of uncontrolled GI disease that may significantly alter the administration or absorption of dabrafenib and\u002For trametinib (e.g. history of diverticulitis, metastases to the GI tract, uncontrolled Crohn's disease, uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome).\n\nG. Clinically significant cardiac or cerebrovascular disease as defined by:\n\n* Unstable angina within three months prior to screening;\n* Myocardial infarction within three months prior to screening;\n* History of documented congestive heart failure (New York Heart Association functional classification III\u002FIV) etc.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) within three months prior to screening.\n\n• Patients with primary central nervous system (CNS) tumours may be considered unless intratumoural bleeding has occurred within two weeks prior to the first dose of dabrafenib and trametinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nH. Patients who were administered a live, attenuated vaccine within 28 days prior to initiation of treatment, or anticipation of need for such a vaccine during investigational medicinal product (IMP) treatment or within six months after the final dose of dabrafenib and trametinib.\n\nI. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of dabrafenib and trametinib including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided that each of the following conditions are met:\n\n* CD4 count ≥350\u002FµL;\n* Undetectable viral load;\n* Receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* No HIV\u002Facquired immune deficiency syndrome associated opportunistic infection in the last 12 months.\n\nJ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial (including absorption of oral medications) that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.","1 Year",{"count":172,"type":19},30,[65,22],"This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in children with glioma (a type of brain tumour). This means they have gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dabrafenib and trametinib work in patients with a particular mutation in their cancer known as BRAF V600.\n\nInvestigators now wish to find out if they will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[176,177,178,112,28,179,180,181,182,183,184,185,34,186,187,127,188,189,190],"Haematological Malignancy","Malignant Neoplasm","Lymphoproliferative Disorders","Gastrointestinal Cancer","Non-Melanoma Skin Cancer (NMSC)","Langerhans Cell Histiocytosis (LCH)","Cancer","Erdheim-Chester Disease","Thyroid Carcinoma, Papillary","Ovarian Neoplasms","Laryngeal Neoplasms","Carcinoma, Non-Small Cell-Lung","Multiple Myeloma","Thyroid Carcinoma, Anaplastic","Solid Tumour",[192,145,182,193,194,195,196,197,198,199,28,200,201,202,203,204,205,206,207],"Adult","Child","Dabrafenib","Malignancy","Malignant Neoplasms","Molecular Targeted Therapy","Mutation","Neoplasms by Histologic Site","Paediatric","Precision Medicine","Proto-Oncogene Proteins B-raf","Protein Kinase Inhibitors","Rare","Trametinib","Tumour-Agnostic","Young adult","NOT_YET_RECRUITING","2026-02-23",{"date":211,"type":45},"2026-02-27",{"date":213,"type":19},"2026-02",{"date":215,"type":19},"2029-10",{"name":217,"class":161},"Cancer Research UK",27,{"id":220,"slug":4,"hasResults":10,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":168,"eligibilityCriteria":224,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":20,"phases":226,"briefSummary":227,"conditions":228,"keywords":232,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":251,"locationsCount":252},"100592057","NCT06988475","DETERMINE Trial Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 06 (CAPMATINIB) OUTLINED BELOW\\*\n\n\\*When capmatinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the capmatinib-specific criteria will take precedence.\n\nInclusion criteria:\n\nA. Confirmed diagnosis of a MET-positive malignancy using an analytically next-generation sequencing method (METex14 skipping, MET amplification, MET fusion, or MET activating mutation).\n\nB. Adult patients ≥18 years old.\n\nC. Women of childbearing potential are eligible, provided that they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment, and\n* Agree to use one form of highly effective birth control method (a method that can achieve a failure rate of \\\u003C1% when used consistently and correctly), such as:\n\nI. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\])\n\nII. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)\n\nIII. intrauterine device (IUD)\n\nIV. Intrauterine hormone-releasing system (IUS)\n\nV. bilateral tubal occlusion\n\nVI. vasectomised partner\n\nVII. sexual abstinence\n\nEffective from the first administration of capmatinib, throughout the trial and for seven days after the last administration of capmatinib.\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from first administration of capmatinib, throughout the trial and for seven days after the last administration of capmatinib:\n\n* Agree to take measures not to father children by using a barrier method of contraception (e.g. condom) or sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception, as in criterion C above.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nE. Patients must be able and willing to undergo a fresh biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nF. Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nExclusion criteria:\n\nA. Diagnosis of NSCLC with METex14 skipping mutation or MET amplification.\n\nB. Prior treatment with a selective MET inhibitor or HGF-targeting therapy unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to capmatinib.\n\nC. Carcinomatous meningitis.\n\nD. Presence or history of additional malignant disease that has been diagnosed and\u002For required therapy within the past three years. Exceptions to this exclusion include: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.\n\nE. Presence or history of interstitial lung disease (ILD) and\u002For interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention) and evidence of active pneumonitis on screening chest computed tomography (CT) scan. Prior localised radiotherapy related pneumonitis is permitted if resolved and off steroids and asymptomatic for at least six months.\n\nF. Clinically significant, uncontrolled heart disease such as:\n\n* Unstable angina within three months prior to screening\n* Myocardial infarction within three months prior to screening\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\n* Uncontrolled hypertension defined by a systolic blood pressure ≥160 mm Hg and\u002For diastolic blood pressure ≥100 mm Hg, with or without antihypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) within three months before screening.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within two weeks of the first dose of capmatinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nG. History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the trial such as:\n\n* Concomitant clinically significant cardiac arrhythmias (atrial and ventricular), e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker\n* History of familial long QT syndrome or known family history of Torsades de Pointes\n* Resting QTcF (Corrected QT interval by Fridericia formula) ≥450 msec (male) or ≥460 msec (female) at screening ECG (as a mean of triplicate ECG)\n\nH. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within four weeks prior to starting trial treatment (two weeks for resection of brain lesions) or patients who have not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and patients can be enrolled in the trial at least one week after the procedure.\n\nI. Patients receiving treatment with strong inducers of cytochrome P450 (CYP) 3A that cannot be discontinued at least one week prior to the start of treatment with capmatinib and for the duration of the trial.\n\nJ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial (including absorption of oral medications) that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.\n\nK. Any impairment of gastrointestinal (GI) function or GI disease that may significantly alter the administration or absorption of capmatinib (e.g., Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome). Unable to swallow capmatinib intact, without chewing or crushing the tablets (as per the dosing schedule).\n\nL. Active infections including, but not limited to, hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Screening for known chronic conditions is not required. Patients with known serological evidence of chronic HBV or HCV infection whose disease is controlled under antiviral therapy according to local regulation are eligible. Patients with history of testing positive for human immunodeficiency virus (HIV) infection are eligible provided the each of the following conditions are met:\n\n* CD4 count ≥350\u002FμL;\n* undetectable viral load;\n* receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* no HIV\u002F acquired immune deficiency syndrome-associated opportunistic infection in the last 12 months.\n\nM. Known hypersensitivity to any of the excipients of capmatinib.\n\nN. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the two weeks prior to trial entry to manage CNS symptoms. Primary brain or CNS malignancies are allowed providing the patient is clinically stable (if corticosteroids are required, they must be at a stable or decreasing dose for at least 14 days prior to Cycle 1 Day 1). If patients are on corticosteroids for endocrine deficiencies or tumour-associated symptoms other than CNS related, the dose must have been stabilised (or decreasing) for at least five days before Cycle 1 Day 1.\n\nO. Patients receiving treatment with any enzyme-inducing anticonvulsant that cannot be discontinued at least one week before first dose of capmatinib, and for the duration of the trial. Patients on non-enzyme-inducing anticonvulsants are eligible.\n\nP. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for seven days following their last dose of capmatinib.\n\nQ. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during capmatinib treatment or within six months after the final dose of capmatinib.",{"count":172,"type":19},[65,22],"This clinical trial is looking at a drug called capmatinib. Capmatinib is approved as standard of care treatment for adult patients with certain types of lung cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nCapmatinib works in patients with lung cancer with a particular mutation in their cancer known as a METex14 skipping mutation.\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which have the same mutation or other specific mutations or changes which take place in the MET gene. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[190,176,177,112,28,182,195,127,229,230,231],"Neuroblastoma","Gastric Cancer","Soft Tissue Sarcoma",[233,234,235,236,237,238,239,240,145,241,242,196,197,198,112,28,201,203,204,243,244],"adult","capmatinib","MET Tyrosine Kinase Receptor","MET exon 14 skipping","MET amplifications","MET fusions","MET activating mutations","MET dysregulations","cancer","malignancy","Tumour-agnostic","METex14 skipping","2025-11-19",{"date":247,"type":45},"2025-11-24",{"date":249,"type":45},"2024-11-19",{"date":215,"type":19},{"name":217,"class":161},17,{"id":254,"slug":4,"hasResults":10,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":168,"eligibilityCriteria":258,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":20,"phases":260,"briefSummary":261,"conditions":262,"keywords":266,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":273,"locationsCount":218},"100498421","NCT05770037","DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ALK Positive Cancers","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ALK Positive Cancers","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 01 (ALECTINIB) OUTLINED BELOW\\*\n\n\\*When alectinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the alectinib-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of an ALK-positive malignancy using an analytically validated next-generation sequencing method.\n\nB. Women of childbearing potential are eligible, provided that they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment and;\n* Agree to use one form of highly effective birth control method such as:\n\nI. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\]\n\nII. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable)\n\nIII. intrauterine device (IUD)\n\nIV. intrauterine hormone-releasing system (IUS)\n\nV. bilateral tubal occlusion\n\nVI. vasectomised partner\n\nVII. sexual abstinence\n\nEffective from the first administration of alectinib, throughout the trial and for three months after the last administration of alectinib.\n\nC. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from first administration of alectinib, throughout the trial and for three months after the last administration of alectinib:\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception, as in criterion B, above.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nD. Patients must be able and willing to undergo a fresh tissue biopsy. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nE. Paediatric patients (patients aged \\\u003C18 years) must have a body weight ≥40kg.\n\nF. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nG. PAEDIATRIC PATIENTS (\\\u003C18 years): Adequate organ function as per haematological and biochemical indices within the ranges shown below. These measurements should be performed to confirm the patient's eligibility.\n\nExclusion Criteria:\n\nA. Diagnosis of ALK-positive non-small cell lung cancer.\n\nB. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for three months following their last dose of alectinib.\n\nC. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to alectinib. Patients who have previously received crizotinib (Xalkori\\^\\[®\\]) and did not respond, or who responded inadequately or responded adequately and subsequently progressed, are allowed into the trial.\n\nD. History of or radiological evidence of interstitial lung disease and\u002For pneumonitis. Prior localised radiotherapy related pneumonitis is permitted if resolved and off steroids and asymptomatic for \\>6 months.\n\nE. Patients at risk of gastrointestinal (GI) perforation e.g. history of diverticulitis, concomitant use of medicinal product with a recognized risk of GI perforation (unless patient has also been co-prescribed gastric protection).\n\n• Patients who present with a GI primary tumour or metastases to the GI tract may be considered.\n\nF. Patient unable to swallow or tolerate oral medication or any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or following major bowel resection. Paediatric patients will be excluded if they are unable to swallow the capsules, as per the dosing schedule (150 mg dose strength).\n\nG. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias (within three months), or New York Heart Association (NYHA) class III or IV congestive heart failure.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]), or cardiovascular event (including acute myocardial infarction \\[MI\\]), within three months before the first dose of alectinib.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of alectinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nH. History of organ transplantation.\n\nI. Symptomatic bradycardia for age.\n\nJ. Known hypersensitivity to alectinib or any of the excipients. See the current alectinib (Alecensa® 150 mg hard capsules) SmPC for the full list.\n\nK. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during alectinib treatment or within six months after the final dose of alectinib.\n\nL. Active hepatitis B or C virus or known human immunodeficiency virus (HIV) positivity or acquired immune deficiency syndrome (AIDS) related illness. Patients with history of testing positive for HIV infection are eligible provided the each of the following conditions are met:\n\n* CD4 count ≥350\u002FμL;\n* undetectable viral load;\n* receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* no HIV\u002FAIDS-associated opportunistic infection in the last 12 months.\n\nM. Familial or personal history of congenital bone disorders, bone metabolism alterations or known osteopenia in the patient.\n\nN. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.",{"count":172,"type":19},[65,22],"This clinical trial is looking at a drug called alectinib. Alectinib is approved as standard of care treatment for adult patients with certain types of lung cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Alectinib works in lung cancer patients with a particular mutation in their cancer known as ALK.\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[176,177,178,112,28,182,263,264,265,229,190],"Anaplastic Large Cell Lymphoma","Lymphoma","Renal Cell Carcinoma",[192,267,268,145,182,193,195,196,197,198,199,28,200,201,203,204,243,207],"Alectinib","ALK Tyrosine Kinase Receptor",{"date":247,"type":45},{"date":271,"type":45},"2023-12-18",{"date":215,"type":19},{"name":217,"class":161},{"id":275,"slug":4,"hasResults":10,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":168,"eligibilityCriteria":279,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":20,"phases":281,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":293,"locationsCount":218},"100498460","NCT05770544","DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ROS1 Gene Fusion-Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ROS1 Gene Fusion-Positive Cancers.","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 03 (ENTRECTINIB) OUTLINED BELOW\\*\n\n\\*When entrectinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the entrectinib-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of a ROS1 gene fusion-positive malignancy, other than NSCLC, that has been identified using an analytically validated next-generation sequencing method.\n\nB. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nC. Patients with a BSA of 0.43m\\^2 and over.\n\nD. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nE. PAEDIATRIC PATIENTS (\\\u003C18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nF. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment and either:\n* Agree to use one form of highly effective birth control method such as:\n\nI. Oral, intravaginal or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation\n\nII. Oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation\n\nIII. Intrauterine device (IUD)\n\nIV. Intrauterine hormone-releasing system (IUS)\n\nV. Bilateral tubal occlusion\n\nVI. Vasectomised partner\n\nPlus a barrier method if using a hormonal method: male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide OR\n\n• Sexual abstinence;\n\nEffective from the first administration of entrectinib, throughout the trial and for five weeks after the last administration of entrectinib.\n\nG. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of entrectinib, throughout the trial and for three months after the last administration of entrectinib:\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception as in F above.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nExclusion Criteria:\n\nA. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within five weeks following their last dose of entrectinib\n\nB. Diagnosis of ROS1 fusion-positive NSCLC\n\nC. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to entrectinib\n\nD. Patients with significant cardiovascular disease are excluded as defined by:\n\ni. Current congestive heart failure requiring therapy (New York Heart Association III or IV) or known left ventricular ejection fraction (LVEF) \\\u003C50% (moderate to severe).\n\nii. History of unstable angina pectoris or myocardial infarction up to three months prior to trial entry, or current poorly controlled angina (symptoms weekly or more).\n\niii. Presence of symptomatic or severe valvular heart disease (severe by local echo graphic criteria or American Heart Association\u002FAmerican Cardiac College Stage C or D).\n\niv. History of a clinically significant cardiac arrhythmia up to three months prior to trial entry (asymptomatic atrial fibrillation or asymptomatic first-degree heart block are permitted.\n\nv. History of stroke (ischaemic or haemorrhagic) within the last three months.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of entrectinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nE. Patients with a baseline QTcF (Corrected QT interval by Fridericia formula) interval longer than 450 milliseconds (ms) for male patients and 470 ms for female patients, patients with congenital long QTcF syndrome, and patients taking medicinal products that are known to prolong the QTc interval.\n\nF. History of additional risk factors for Torsades de Pointes (e.g., family history of long QT syndrome)\n\nG. Grade ≥2 peripheral neuropathy\n\nH. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of entrectinib, including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided the each of the following conditions are met:\n\n* CD4 count ≥350\u002FμL;\n* undetectable viral load;\n* receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* no HIV\u002F acquired immune deficiency syndrome (AIDS)-associated opportunistic infection in the last 12 months.\n\nI. Known hypersensitivity to entrectinib or any of the excipients\n\nJ. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during entrectinib treatment or within six months after the final dose of entrectinib\n\nK. Patient unable to swallow entrectinib intact, without chewing, crushing or opening the capsules (as per the dosing schedule and suitable dosing strengths available). Any active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably affect drug absorption\n\nL. Patients with personal history of significant osteopenia (screening for osteopenia not required)\n\nM. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial",{"count":172,"type":19},[65,22],"This clinical trial is looking at a drug called entrectinib. Entrectinib is approved as standard of care treatment for adult patients with non-small cell lung cancer (NSCLC) which have a particular molecular alteration called ROS1-positive, and patients 12 years old or above with solid tumours which have another type of change in the cancer cells. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which have the same molecular alteration (ROS1-positive). If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[176,195,177,178,112,28,182,69,284,127,190],"Melanoma",[192,145,182,193,286,195,196,197,198,199,28,287,200,203,204,288,243,207],"Entrectinib","Oncogene","ROS1 Protein, human",{"date":247,"type":45},{"date":291,"type":19},"2025-11-30",{"date":215,"type":19},{"name":217,"class":161},{"id":295,"slug":4,"hasResults":10,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":168,"eligibilityCriteria":299,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":20,"phases":301,"briefSummary":302,"conditions":303,"keywords":306,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":312,"locationsCount":218},"100498426","NCT05770102","DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With High TMB or MSI-high or Proven CMMRD Disposition.","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 02 (ATEZOLIZUMAB) OUTLINED BELOW\\*\n\n\\*When atezolizumab-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the atezolizumab-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of a malignancy that is high TMB (defined as ≥10 mut\u002FMb), MSI-high or of proven (previously diagnosed) CMMRD disposition using an analytically validated next-generation sequencing method. Patient cases with TMB between 10-15 mut\u002FMb may be discussed in an MTB meeting. TMB ≥19 mut\u002FMb will be fast-tracked for an MTB recommendation, unless there are any patient-specific individualities (such as multiple gene amplifications) that require MTB discussion.\n\nB. Women of childbearing potential are eligible provide they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment and;\n* Agree to use one form of effective birth control method such as:\n\nI. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (\\[oral, intravaginal or transdermal\\]);\n\nII. progestogen-only hormonal contraception associated with or without inhibition of ovulation (oral, injectable or implantable);\n\nIII. intrauterine device (IUD),\n\nIV. intrauterine hormone-releasing system (IUS),\n\nV. bilateral tubal occlusion,\n\nVI. vasectomised partner,\n\nVII. sexual abstinence,\n\nVIII. male or female condom with or without spermicide;\n\nIX. cap, diaphragm or sponge with spermicide.\n\nEffective from the first administration of atezolizumab, throughout the trial and for five months after the last administration of atezolizumab.\n\nC. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of atezolizumab, throughout the trial until the last administration of atezolizumab:\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses an effective method of contraception.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nD. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nE. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nF. PAEDIATRIC PATIENTS (\\\u003C18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nG. Patients must have stable thyroid function tests. Patients on stable doses of thyroxine replacement are permitted.\n\nExclusion Criteria:\n\nA. Diagnosis of urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, hepatocellular carcinoma or triple negative breast cancer.\n\nB. Patients with rapidly progressing or symptomatically deteriorating brain metastases and\u002For leptomeningeal disease. Patients with previously treated brain metastases are eligible, provided the patient has not experienced a seizure or had a clinically significant change in neurological status within 14 days (for adult patients) or 7 days (for paediatric patients) prior to the start of IMP administration. Such patients must be non-dependent on steroids or on a stable or reducing dose of steroid treatment for at least 14 days (or 7 days for paediatric patients) prior to the start of IMP administration. Primary brain or central nervous system (CNS) malignancies are allowed providing the patient is clinically stable (if requiring corticosteroids must be at stable or decreasing doses for at least 14 days for adults and 7 days for paediatric patients prior to the start of IMP administration). Patients who have received brain irradiation must have completed whole-brain radiotherapy and\u002For stereotactic radiosurgery at least 14 days prior to the start of IMP administration.\n\n• Paediatric patients with either primary brain tumours or extracranial solid tumours with intracranial metastases with one or more intracranial lesions should only be considered for inclusion if largest intracranial lesion is ≤6 cm in longest axis. Consideration should also be given to the intracranial location of the tumour and potential risk should swelling occur. This is because of the class risk of immune checkpoint inhibitors such as atezolizumab causing immune-mediated inflammatory response and 'tumour flare' which may result in acute neurological deterioration.\n\nC. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within five months following their last dose of atezolizumab.\n\nD. History or clinical evidence of current inflammatory lung disease:\n\n* History of idiopathic pulmonary fibrosis, organising pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.\n* Evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n\nE. Active autoimmune disease that requires the use of systemic immunomodulatory therapy (i.e. with disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy for hypothyroidism and adrenal or pituitary insufficiency is acceptable.\n\nF. Ongoing lung pathologies which, in the opinion of the Investigator present a compromise to safety (e.g. active tuberculosis).\n\nG. Systemic immunomodulatory agents within 14 days prior to trial entry (immunostimulatory agents within four weeks). Exceptions to this are:\n\n* Patients who received acute, low dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g. 48 hours of corticosteroids for a contrast allergy) are eligible for the trial.\n* Patients who received corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma equivalent to ≤10 mg prednisolone a day or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the trial.\n* Patients with primary CNS disease can be receiving concurrent treatment with corticosteroids. Patients must be receiving a stable or decreasing dose for ≥14 days for adults and ≥7 days for paediatric patients prior to the screening magnetic resonance imaging (MRI) scan and at the time of drug initiation.\n* Patients who receive physiological doses of steroid replacement (e.g. hydrocortisone) are permitted.\n\nH. Known to be serologically positive (as detected by polymerase chain reaction) for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n\nI. History of severe allergic anaphylactic reactions to chimeric, human or humanised antibodies, or fusion proteins including other immune checkpoint inhibitors.\n\nJ. Known hypersensitivity to Chinese hamster ovary cell products.\n\nK. Known hypersensitivity to atezolizumab or any of the excipients.\n\nL. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during atezolizumab treatment or within six months after the final dose of atezolizumab.\n\nM. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or NYHA class III or IV congestive heart failure.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attacks \\[TIA\\]) or cardiovascular event (including acute myocardial infarction \\[MI\\]) within three months before the first dose of atezolizumab.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of atezolizumab, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nPatients with a prior history of pericardial disorders, including pericarditis, pericardial effusion and cardiac tamponade.\n\nN. Prior allogeneic stem cell or solid organ transplantation on immunosuppression.\n\nO. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to atezolizumab.\n\nP. Uncontrolled diabetes.\n\nQ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.\n\nR. Severe infection within four weeks prior to the first IMP administration or the administration of antibiotics within two weeks prior to the first IMP administration, with the exemption of patients requiring prophylaxis.",{"count":172,"type":19},[65,22],"This clinical trial is looking at a drug called atezolizumab. Atezolizumab is approved as standard of care treatment for adult patients with urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, hepatocellular carcinoma and triple negative breast cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nAtezolizumab works in patients with these types of cancers which have certain changes in the cancer cells called high tumour mutational burden (TMB) or high microsatellite instability (MSI) or proven (previously diagnosed) constitutional mismatch repair deficiency (CMMRD).\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which are also TMB\u002FMSH-high or show CMMRD. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[195,177,178,112,28,182,34,304,284,305],"Endometrial Neoplasms","Solid Tumours",[192,145,307,182,193,195,196,197,112,28,200,201,204,243,207],"Atezolizumab",{"date":247,"type":45},{"date":310,"type":45},"2023-10-25",{"date":215,"type":19},{"name":217,"class":161},{"id":314,"slug":4,"hasResults":10,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":20,"phases":322,"briefSummary":323,"conditions":324,"keywords":334,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":346},"100534368","NCT06237920","Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab","A Phase 2 Trial in Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab","TURANDORELA","Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Age ≥ 18 years\n* Resectable muscle-invasive UC of the bladder, defined as cT2-4aN0M0 OR cT1-4aN1M0. In cT1N1 patients, lymph node positivity would need to be cytologically or histologically confirmed.\n* Surgical resection (cystectomy) is the advised locoregional treatment and is accepted by the subject after consultation with the urologist.\n* Patients are either cisplatin ineligible or elect to not undergo cisplatin based neoadjuvant chemotherapy after a balanced discussion of risks and benefits with the treating physician. Cisplatin eligibility is determined based on the Galsky criteria\n* World Health Organization (WHO) performance Status 0 or 1.\n* Urothelial cancer is the dominant histology (\\>50%). Any component of small cell or adenocarcinoma is not allowed.\n* Formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks from diagnostic TUR available.\n* Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109\u002FL, Platelets ≥100 x109\u002FL, Hemoglobin ≥5.5 mmol\u002FL, GFR\\>30 ml\u002Fmin, AST ≤ 1.5 x ULN, ALT ≤1.5 x ULN, Bilirubin ≤1.5 X ULN\n* Negative pregnancy test (βHCG in blood or urine) within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential.\n* Highly effective contraception for female subjects if the risk of conception exists. Female patients of childbearing potential must comply with contraception methods as requested by the study protocol (→ 8.2.1 Pregnancy, contraception and breastfeeding)\n\nExclusion Criteria:\n\n* Subjects with active autoimmune disease in the past 2 years. Patients with diabetes mellitus, properly controlled hypothyroidism or hyperthyroidism, vitiligo, psoriasis or other mild skin disease can still be included.\n* Documented history of severe autoimmune disease (e.g. inflammatory bowel disease, myasthenia gravis).\n* Previous intravenous systemic therapy or radiotherapy for UC.\n* Upper urinary tract disease, unless all disease is planned to be resected in the same surgery as for UBC. This includes non-muscle-invasive disease.\n* Prior CTLA-4, LAG3 or PD-1\u002FPD-L1-targeting immunotherapy.\n* Known active Human Immunodeficiency Virus infection, or tuberculosis, or other active infection:\n* HIV-positive patients are eligible if the following applies:\n* No AIDS defining opportunistic infection within the last year and a current CD4 count \\>350 cells\u002FuL.\n* Received antiretroviral therapy (ART) for at least 4 weeks prior to treatment and continued while enrolled on study\n* CD4 counts and viral load are monitored per standard of care by a local health care provider\n* In patients with a known history of hepatitis B or hepatitis C infection, Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA) should be negative\n* Underlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples may include severe pulmonary disease with extensive radiological abnormalities or intestinal disease causing severe diarrhea, not covered by other eligibility criteria, that may obscure colitis.\n* Medical condition requiring the use of immunosuppressive medications, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) will be allowed.\n* Use of other investigational drugs before study drug administration.\n* Malignancy, other than urothelial cancer, in the previous 2 years, with a high chance of recurrence (estimated \\>10%). Patients with low-risk prostate cancer (defined as Stage T1\u002FT2a, Gleason score ≤ 6, and PSA ≤ 10 ng\u002FmL) who are treatment-naive and undergoing active surveillance are eligible.\n* Pregnant and lactating female patients.\n* Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.\n* Severe infections within 2 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to enrolment, unstable arrhythmias and unstable angina.",{"count":321,"type":19},90,[65],"This is a non-blinded phase 2 trial in Stage II-IIIa urothelial cancer randomizing pre-operative nivolumab with or without relatlimab to assess whether bladder preservation after dual immunotherapy would be a viable treatment option for patients responding to treatment",[325,326,28,70,327,328,329,330,331,332,333],"Urologic Neoplasms","Urogenital Neoplasms","Female Urogenital Diseases","Female Urogenital Diseases and Pregnancy Complications","Urogenital Diseases","Urinary Bladder Diseases","Male Urogenital Diseases","Urinary Bladder Neoplasm","Antineoplastics Toxicity",[335,336],"Nivolumab","Relatlimab","2025-09-01",{"date":339,"type":45},"2025-09-03",{"date":341,"type":45},"2024-02-19",{"date":343,"type":19},"2028-08-01",{"name":345,"class":161},"The Netherlands Cancer Institute",9,{"id":348,"slug":4,"hasResults":10,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":20,"phases":355,"briefSummary":356,"conditions":357,"keywords":362,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":375},"100406441","NCT04572451","Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma","Phase I Study Investigating the Safety of Stereotactic Body Radiotherapy (SBRT) With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma","Inclusion Criteria:\n\n* SAFETY COHORT\n\n  1. Patients with advanced\u002Fmetastatic\u002Funresectable solid tumors progressed on standard therapies. Patients with melanoma and RCC will make up approximately 30% of total cohort.\n  2. Patients with 1-4 tumor sites that can be irradiated safely\n  3. Age \\> or equal 18 years\n  4. ECOG performance status 0 or 1\n  5. Patients must have normal organ and marrow function as defined below:\n\n     * Leukocytes ≥ 3000\u002FmcL;\n     * absolute neutrophil count ≥ 1500\u002FmcL;\n     * Platelets ≥ 100,000\u002FmcL;\n     * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) ;\n     * Total bilirubin ≤ 1.5 × ULN (except participants with Gilbert's Syndrome who must have normal direct bilirubin)\n     * Serum creatinine ≤ 1.5 × ULN 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 ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam\n  6. Ability to understand and the willingness to sign a written informed consent document.\n  7. Reproductive status\n\n     * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study treatment.\n     * Women must not be breastfeeding.\n     * WOCBP must agree to follow instructions for method(s) of contraception (Appendix 5) for the duration of study treatment plus 5 half-lives of nivolumab plus 30 days (duration of ovulatory cycle), for a total of 155 days post treatment completion. Local laws and regulations may require use of alternative and\u002For additional contraception methods.\n     * WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, but should still undergo pregnancy testing as described in this section.\n     * Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (Appendix4) during combination treatment with study treatment BMS-986253 and nivolumab, plus 5 half-lives of nivolumab (∼125 days), plus 90 days (duration of sperm turnover), for a total of 215 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time.\n* EFFICACY COHORT\n\n  1. Patients with anti-PD1\u002FPDL1 refractory melanoma\n  2. Patients with 1-4 tumor sites that can be irradiated safely\n  3. Age ≥ 18 years\n  4. ECOG performance status 0 or 1\n  5. Patients must have normal organ and marrow function as defined above for safety cohort\n  6. 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 ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam\n  7. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Known or suspected CNS metastases, with the following exceptions:\n\n   a) Subjects with controlled brain metastases will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following 18 radiation and\u002For surgical treatment at the time of randomization. b) Subjects must be off steroids for at least 2 weeks prior to initiation of investigational therapy c) Subjects with signs or symptoms of brain metastases are not eligible unless brain metastases are ruled out by computed tomography or magnetic resonance imaging.\n2. Medical History and Concurrent Diseases\n\n   * Patients who are receiving any other investigational agents.\n   * History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab and BMS-986253\n   * Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n   * Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:\n\n     i. Myocardial infarction (MI) or stroke\u002Ftransient ischemic attack (TIA) within the 6 months prior to consent ii. Uncontrolled angina within the 3 months prior to consent iii. Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes, or poorly controlled atrial fibrillation) within a month prior to consent iv. QTc prolongation \\> 480 msec v. History of other clinically significant cardiovascular disease (i.e., cardiomyopathy, congestive heart failure with New York Heart Association \\[NYHA\\] functional classification III-IV, pericarditis, significant pericardial effusion, significant coronary stent occlusion, poorly controlled deep venous thrombosis, etc) vi. Cardiovascular disease-related requirement for daily supplemental oxygen vii. History of two or more coronary revascularization procedures within the 3 months prior to consent viii. Subjects with history of myocarditis, regardless of etiology\n   * A confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent\n   * Subjects with history of life-threatening toxicity related to prior immune therapy (eg. anti-CTLA-4 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy).\n   * Subject has been administered prior chemotherapy or immunotherapy at any time, and any with radiation therapy within 4 weeks prior to time of consent or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to previously administered agent.\n\n     1. Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.\n     2. Subjects with endocrinopathy which is adequately controlled with hormone replacement therapy are an exception to this criterion and may qualify for the study.\n   * If subject underwent major surgery, subject must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n   * Subject has a known additional malignancy that is progressing or requires active treatment. Exceptions 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   * A known or underlying medical condition that, in the opinion of the investigator could make the administration of study drug hazardous to the subject or could adversely affect the ability of the subject to comply with or tolerate study therapy.\n   * Pregnant women are excluded from this study because of 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, breastfeeding should be discontinued if the mother is treated with the study drugs.\n   * Subjects who are unable to undergo venipuncture and\u002For tolerate venous access\n   * Evidence of active infection that requires systemic antibacterial, antiviral, or antifungal therapy ≤ 7 days prior to initiation of study drug therapy\n   * Subjects who are on immunosuppressive therapy (systemic steroids 10mg and more daily use)\n   * Prisoners or subjects who are involuntarily incarcerated\n   * Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness\n   * Inability to comply with restrictions and prohibited activities and treatments",{"count":354,"type":19},50,[64],"Nivolumab (and other agents affecting the anti-programmed death-1 \\[anti-PD-1\\] pathway) have demonstrated anti-tumor activity in multiple tumor types. Combinations of immune-oncology (IO) agents with complimentary mechanisms as well as radiation represent a promising strategy to improve response rates to immunotherapy and overcome resistance. In this phase I\u002FIb study, radiation will be used in combination with IO agents nivolumab and anti-IL-8 (BMS-986253) to assess toxicity by organ system and then assess the preliminary efficacy of the treatment regimen. In Part 1, the study will determine the safe doses of radiation by organ site in conjunction with nivolumab and BMS-986253. In Part 2, the treatment regimen will be investigated in melanoma, prioritizing acral melanoma, to describe the response rate to treatment as well as other clinical and safety outcomes. The study will also provide the opportunity to evaluate changes in the tumor microenvironment induced by the treatment.",[284,358,70,112,28,359,145,360,361,335],"Unresectable Solid Tumors","Antineoplastic Agents, Immunological","Immune Checkpoint Inhibitors","Molecular Mechanisms of Pharmacological Action",[363,364,365],"Anti-PD-1 monoclonal antibody (mAb)","Anti-IL-8","Stereotactic Body Radiotherapy (SBRT)","2025-07-29",{"date":368,"type":45},"2025-08-01",{"date":370,"type":45},"2021-11-29",{"date":372,"type":19},"2027-05-31",{"name":374,"class":161},"Yana Najjar",2,{"id":377,"slug":4,"hasResults":10,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":20,"phases":385,"briefSummary":386,"conditions":387,"keywords":397,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":431},"100484789","NCT05592626","A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors","A Phase 1\u002F2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)","START-001","Inclusion Criteria:\n\n1. Participants must have histologically confirmed solid tumors that are unresectable, locally advanced, or metastatic and for which standard curative therapies do not exist or are no longer effective or have intolerable toxicities. Subjects should not have received more than three lines of prior therapies for their advanced or metastatic diseases.\n2. For Phase 1, participants must have one of the following solid tumors:\n\n   1. High mutational burden (TMB-H)\n   2. Microsatellite Instability (MSI-H)\u002FDNA mismatch repair (dMMR)\n   3. Virally associated tumors\n3. For Phase 2, participants must have one of the following solid tumors:\n\n   1. TMB-H\n   2. MSI-H\u002FdMMR\n   3. CRC (both Ras wild type and mutant)\n   4. Virally associated tumors\n   5. Metastatic triple negative breast cancer\n   6. Platinum-resistant epithelial ovarian cancer\n   7. Metastatic castration-resistance prostate cancer\n   8. Primary stage IV or recurrent non-small cell lung cancer\n   9. Immunogenic solid tumors\n\n   (Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.)\n4. Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:\n\n   * No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids \\> 10 mg prednisone\u002Fday or equivalent);\n   * No concurrent leptomeningeal disease or cord compression.\n\nExclusion Criteria:\n\n1. Participants with a history of known autoimmune disease with exceptions of:\n\n   * Vitiligo;\n   * Psoriasis, atopic dermatitis or other autoimmune skin condition not requiring systemic treatment;\n   * History of Graves' disease, now euthyroid for \\> 4 weeks;\n   * Hypothyroidism managed by thyroid replacement;\n   * Alopecia;\n   * Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs.\n   * Adrenal insufficiency well controlled on replacement therapy.\n2. Major surgery or traumatic injury within 8 weeks before first dose of study drug.\n3. Unhealed wounds from surgery or injury.\n4. Treatment with \\>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for patients who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.\n5. Clinically significant cardiovascular\u002Fvascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises\n6. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.\n7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.\n8. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.\n9. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.\n10. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).\n11. Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.",{"count":384,"type":19},365,[64,65],"This is an open label, multicenter, phase 1\u002F2 study to assess the safety\u002Ftolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.",[388,389,326,390,28,391,392,393,70,394,395,396],"Advanced Solid Tumors","Genital Neoplasm, Female","Lung Neoplasm","Papillomavirus Infection","Epstein-Barr Virus Infections","Carcinoma","Vulvar Neoplasms","Vulvar Diseases","Abdominal Neoplasm",[388,398,399,145,400,401,402,403,404,405,406,143,407,408,409,410,411,412,284,413,414,415,416,417,418,419,26,230,420,421],"STAR0602","Intravenous","T Cell Receptor-targeting","Bifunctional Antibody-Fusion","Specific T Cell Activator","Tumor Mutational Burden (TMB) High","Microsatellite Instability (MSI) High","Virally Associated Malignancies","Checkpoint Inhibitor Resistance","Immune Checkpoint Inhibitor Resistance","Head and Neck Cancer","Nasopharyngeal Cancer","Non-small Cell Lung Cancer","Small Cell Lung Cancer","Biliary Cancer","Merkel Cell Carcinoma","Skin Squamous Cell Carcinoma","Skin Basal Cell Carcinoma","Endometrial Cancer","Colorectal Cancer","Small Bowel Cancer","Cervical Cancer","Esophageal Cancer","Bladder Cancer","2025-07-07",{"date":424,"type":45},"2025-07-09",{"date":426,"type":45},"2023-01-04",{"date":428,"type":19},"2026-10",{"name":430,"class":52},"Marengo Therapeutics, Inc.",32,{"id":433,"slug":4,"hasResults":10,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":438,"sex":15,"minAge":439,"maxAge":440,"enrollmentInfo":441,"targetDuration":4,"studyType":20,"phases":443,"briefSummary":445,"conditions":446,"keywords":452,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":466},"100592093","NCT06988943","Early Intervention Strategies for Lung Cancer","Construction and Evaluation of a Hospital-Community Health Collaboration Model Empowered by Digital Technology for Lung Cancer Screening","1.Community Health Service Centers (Cluster Level)\n\n1. Inclusion Criteria The community health service center must be located within one of the 11 districts of Guangzhou.\n\n   The center must manage a population of over 10,000 elderly individuals. The center should be equipped with at least one CT machine and have qualified medical personnel, such as radiologists, radiologic technicians, and nursing staff.\n2. Exclusion Criteria Community health centers currently participating in other public health projects or studies that may affect screening results.\n\nCommunity health service centers where researchers cannot collect data or conduct follow-up.\n\n2\\. Screening Subjects (Individual Level)\n\n1. Inclusion Criteria Aged 40-75 years. Residing in the community participating in the study for a long time. No known history of lung cancer and has not undergone lung cancer screening in the past three months.\n\n   Able to understand and willing to sign the informed consent form, and able to participate in long-term follow-up.\n2. Exclusion Criteria Individuals diagnosed with lung cancer. Individuals with severe other health issues that make them unsuitable for CT imaging.\n\nIndividuals unable to understand the study protocol or who cannot provide informed consent due to cognitive impairments.\n\nIndividuals participating in other clinical trials that may affect the results of this study.\n\nIndividuals unable to undergo follow-up.",true,"40 Years","74 Years",{"count":442,"type":19},16000,[444],"NA","Low-dose CT (LDCT）can detect and treat lung cancer earlier and more quickly, while expanded screening coverage helps reduce the incidence and mortality of respiratory diseases such as lung cancer. This study aims to conduct a single-arm cluster randomized trial of digitally enabled LDCT in Guangzhou to assess its intervention effectiveness and cost-effectiveness.",[447,448,28,70,449,450,451],"Respiratory Tract Neoplasms","Thoracic Neoplasms","Lung Diseases","Respiratory Tract Diseases","Lung Neoplasms",[453,454,455,456],"Screning test","Lung cancer","LDCT","Low-dose CT","2025-05-26",{"date":459,"type":45},"2025-05-30",{"date":461,"type":45},"2024-06-25",{"date":463,"type":19},"2025-06",{"name":465,"class":161},"The First Affiliated Hospital of Guangzhou Medical University",1,{"id":468,"slug":4,"hasResults":10,"nctId":469,"briefTitle":470,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":10,"sex":472,"minAge":473,"maxAge":474,"enrollmentInfo":475,"targetDuration":4,"studyType":20,"phases":477,"briefSummary":478,"conditions":479,"keywords":486,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":499},"100367261","NCT04061967","Research Project on Reminders and Self-Sampling Can Increase Participation in Gynecology Cell Sampling - Preventive Examination Against Cervical Cancer.","Inclusion Criteria:\n\n* Women resident in Region Skane who either: 1) have had glandular cell transformation that has not been followed-up, 2) are older than 65 years and have had cell transformation that has not been followed-up or who have not participated in screening during the last 10 years, 3) women who have not been screened for more than 15 years.\n\nExclusion Criteria:\n\n* No exclusion except those who do not consent.","FEMALE","33 Years","75 Years",{"count":476,"type":19},20000,[444],"Prevention of cervical cancer with cervical screening is one of the most successful screening activities in medicine. In Sweden, screening was implemented in the 1960s and has since prevented tens of thousands of women from having cervical cancer. Individual invitations to screening result in increased attendance therefore evaluating strategies for reaching women through invitations is particularly valuable. Women who regularly attend screening following an invitation reduce their risk of cervical cancer by as much as 90%. Of the women who are diagnosed with cervical cancer (about 550 women per year in Sweden), as many as 38% did not participate in the screening. Invitations for screening are sent to the entire population in Sweden aged 23-70. The current coverage of screening is 82.9%, which represents the proportion of women ages 23-70 who attend according to recommendations. In addition, many women are sporadic attenders who reduce their risk for cancer somewhat. The highest cancer risk is seen among those women who have never participated as well as women who have had a history of precancerous lesions or HPV infection but have not been followed-up. Cervical cancer is the first form of cancer for which there are approved molecular screening tests (HPV test). Unlike the older screening method (cytology), self-collected samples can be analyzed for HPV (the analysis method is so sensitive that it does not matter if the sample is not optimally taken).\n\nInvitations and reminders about cervical screening are sent by letter to the woman's home address (about 3 million letters per year in Sweden). This strategy results in a waste of resources and has a negative environmental impact. Regarding reminders, we have seen in previous research that the effect is not optimal. When sending a physical reminder letter to women who have not participated in more than 10 years (current routine), only 2% of the women invited came for sampling. Reminders with SMS are now standard for many businesses in society, such as car testing or dental appointments. It is inexpensive, saves the environment and there are studies that suggest it is more effective than sending physical letters. In this study, we intend to investigate whether SMS reminders, electronic letters, and physical letters for screening lead to increased participation and thus to a higher proportion of detected, treatable precursors of cervical cancer compared to before.",[419,480,481,482,389,483,484,28,70,485],"Uterine Cervical Neoplasm","Uterine Neoplasms","Genital Neoplasm","Uterine Diseases","Genital Diseases, Female","Uterine Cervical Disease",[487,488,489],"participation","self sampling","screening","2025-01-10",{"date":492,"type":45},"2025-01-14",{"date":494,"type":45},"2019-08-19",{"date":496,"type":19},"2030-06-01",{"name":498,"class":161},"Karolinska Institutet",6,{"id":501,"slug":4,"hasResults":10,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":10,"sex":506,"minAge":16,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":20,"phases":509,"briefSummary":511,"conditions":512,"keywords":520,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":466},"100570413","NCT06706921","18F-Fluciclovine PET\u002FCT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer","Usefulness of Tumor Heterogeneity Assessment in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET\u002FCT Predicting Clinical Outcome","Inclusion Criteria:\n\n* Patients with mCRPC scheduled to undergo LuPSMA RLT.\n* Willingness to undergo multiple serial PET\u002FCT scans pre- and post-LuPSMA RLT.\n* Ability of providing written informed consent.\n\nExclusion Criteria:\n\n* Less than 18 years-old at the time of radiopharmaceutical administration.\n* Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.\n* Contraindications to LuPSMA RLT.","MALE",{"count":508,"type":19},15,[510],"PHASE4","This a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography\u002Fcomputed tomography 18F-FDG PET\u002FCT and a 18F-DCFPyL PET\u002FCT (18F-DCFPyL (2-(3-{1-carboxy-5-\\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\\]-pentyl}-ureido)-pentanedioic acid)positron emission tomography\u002Fcomputed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography\u002Fcomputed tomography ( Axumin PET\u002FCT )will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET\u002FCT will be acquired within 7 days from the PSMA PET.\n\nThis study is open to Veterans only.",[513,514,515,331,516,517,518,70,28,326,519],"Prostatic Neoplasms","Prostatic Neoplasms, Castration-Resistant","Metastatic Prostate Cancer","Prostatic Diseases","Urogenital Diseases, Male","Genital Diseases, Male","Genital Neoplasms, Male",[521,522,523,524,525],"Prostate cancer","PET\u002FCT","Radioligand Therapy","Metastatic Castration-Resistant Prostate Cancer","PSMA PET","2024-11-26",{"date":528,"type":45},"2024-11-27",{"date":530,"type":19},"2024-12-15",{"date":532,"type":19},"2027-11-01",{"name":534,"class":535},"VA Greater Los Angeles Healthcare System","FED",{"id":537,"slug":4,"hasResults":10,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":543,"enrollmentInfo":544,"targetDuration":546,"studyType":547,"phases":4,"briefSummary":548,"conditions":549,"keywords":556,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":346},"100400392","NCT04493632","OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.","OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)","OSPREY","Inclusion Criteria:\n\n1. Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC).\n2. Patients who undergo OncoSil™ implantation at an eligible treatment facility.\n3. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPREY Patient Registry.\n4. Pancreatic target tumour recommended size of \\\u003C7 cm (longest diameter) and \\\u003C110 cc volume.\n5. A clinically acceptable ECOG performance status.\n6. Patients ≥ 18 years of age at screening.\n7. To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to the approved prescribing schedule) post Registry enrolment.\n8. Adequate biochemical tests, coagulation profile, haematological, renal, and hepatic function as determined by the Treating Physician.\n\nExclusion Criteria:\n\n1. Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry.\n2. Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored).\n3. Evidence of distant metastases based on review of baseline CT scan.\n4. More than one primary lesion.\n5. In the opinion of the Treating Physician, EUS-directed implantation posing undue patient risk. This includes:\n\n   * where previous EUS-FNA was considered technically too difficult to perform;\n   * imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas;\n   * presence (or significant risk) of varices near to the target tumour.\n6. Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).\n7. In the setting of recent, clinically significant pancreatitis, implantation is not recommended.\n8. Pregnant or intending to commence a pregnancy within 12-months of the intended date of implantation or breastfeeding.\n9. Patients who have a known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components","90 Years",{"count":545,"type":19},500,"24 Months","OBSERVATIONAL","The OSPREY Patient Registry has been developed to collect and assess the performance and safety of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, within a real-world observational registry.\n\nThe Registry data will provide both complementary and contemporary information to the existing clinical data across various countries and will form part of the post-market clinical follow-up activities for OncoSil™. Therefore, the Registry will be implemented only in countries with regulatory (commercial) approval for the OncoSil™ device.",[550,551,28,70,552,553,554,555],"Pancreatic Neoplasm","Digestive System Neoplasm","Endocrine Gland Neoplasm","Digestive System Disease","Pancreatic Diseases","Endocrine System Diseases",[557,558,559,560,561,562,563,564,565,566,567,568,569,570,571],"Pancreatic Cancer","Pancreas","Metastases","Pancreatic tumor","Unresectable","Locally advanced","Implantable","Radiographic","Device","Phosphorous-32","OncoSil™","Brachytherapy","Gemcitabine","Nab-paclitaxel","Abraxane","2024-04-29",{"date":574,"type":45},"2024-04-30",{"date":576,"type":45},"2022-04-12",{"date":578,"type":19},"2027-10-01",{"name":580,"class":52},"OncoSil Medical Limited",{"id":582,"slug":4,"hasResults":10,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":474,"enrollmentInfo":587,"targetDuration":4,"studyType":20,"phases":589,"briefSummary":590,"conditions":591,"keywords":595,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":466},"100529757","NCT06177925","A Phase Ⅱ Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligometastatic SCLC","A Phase Ⅱ Exploratory Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy as First-Line Treatment for Extensive-Stage Oligometastatic Small Cell Lung Cancer","Inclusion Criteria:\n\n* Signed inform consent form\n* Age \\>= 18 years and \\\u003C= 75 years\n* Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \\[VALG\\] staging system)，the number of metastatic lesions ≤ 5, the number of metastatic organs ≤ 3, and no previous systemic chemotherapy, radiotherapy or immune checkpoint inhibitor treatment.\n* Eastern Cooperative Oncology Group performance status of 0 or 1\n* Expected survival time ≥ 3 months\n* Patients must submit a pre-treatment tumor tissue sample during the study.\n* Adequate hematologic and end organ function\n\nExclusion Criteria:\n\n* Spinal cord compression not definitively treated with surgery and\u002For radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization\n* Leptomeningeal disease\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n* Uncontrolled or symptomatic hypercalcemia\n* Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome\n* History of autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease\n* Prior treatment with immune checkpoint blockade therapies\n* Subjects with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.\n* Significant cardiovascular disease\n* Prior allogeneic bone marrow transplantation or solid organ transplant\n* Treatment with systemic immunosuppressive medications within 1 weeks prior to randomization\n* History of hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, carboplatin or etoposide\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator",{"count":588,"type":19},62,[65],"This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of adebelizumab combined with carboplatin\u002FCisplatin plus (+) etoposide and concurrent radiotherapy in the first-line treatment of patients with extensive stage oligometastatic small cell lung cancer.",[447,448,28,70,449,450,592,593,451,594],"Carcinoma, Bronchogenic","Bronchial Neoplasms","Small Cell Lung Carcinoma",[596,597,598,599,600],"Extensive stage small cell lung cancer","Oligometastasis","Adebrelimab","Chemotherapy","Radiotherapy","2023-12-11",{"date":603,"type":45},"2023-12-20",{"date":605,"type":19},"2023-12-10",{"date":607,"type":19},"2026-09-30",{"name":609,"class":161},"Nanfang Hospital, Southern Medical University",{"id":611,"slug":4,"hasResults":10,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":617,"enrollmentInfo":618,"targetDuration":4,"studyType":547,"phases":4,"briefSummary":620,"conditions":621,"keywords":628,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":642},"100435367","NCT04949282","Spanish Series of Patients Treated With the Radionuclide Lutetium177","SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177","SEPTRALU","Inclusion Criteria:\n\n* Written informed consent must be obtained prior to any data collection.\n* Patients must be diagnosed with unresectable or metastatic, progressive, somatostatin receptor positive tumour\n* Aged ≥18 years.\n\nExclusion Criteria:\n\n* None","100 Years",{"count":619,"type":19},5000,"This study aims to pool the clinical experience of Spanish centers treating patients with 177Lu-DOTATATE to evaluate the efficacy, tolerance, and safety of the drug in routine clinical practice and to learn about the profiles of patients and tumors treated and the results in each type of patient and tumor.",[622,25,623,624,101,111,112,70,114,26,27,28,625,29,626,32,627,555],"Neuroendocrine Tumors","Pancreatic Neoplasms","Stomach Neoplasms","Endocrine Gland Neoplasms","Gastrointestinal Disease","Pancreatic Disease",[629,630,631,632],"GEP-NET","Gastro-Entero-Pancreatic Neuroendocrine Tumour","Luthatera","Somatostatin receptor positive tumour","2022-12-22",{"date":635,"type":45},"2022-12-23",{"date":637,"type":45},"2021-05-10",{"date":639,"type":19},"2035-12-31",{"name":641,"class":161},"Sociedad Española de Medicina Nuclear e Imagen Molecular",20,{"id":644,"slug":4,"hasResults":10,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":648,"eligibilityCriteria":649,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":650,"targetDuration":4,"studyType":20,"phases":651,"briefSummary":652,"conditions":653,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":466},"100458627","NCT05252078","Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients","An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients as Postoperative Adjuvant Therapy","ALTER-E005","Inclusion Criteria:\n\n* Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.\n* ≥ 18 years old.\n* ECOG performance status of 0-1\n* Patients with esophageal squamous cell carcinoma pathologically diagnosed as T1-2N1-3M0 or T3-4NanyM0.\n* Patients received radical (R0) resection of squamous cell carcinoma with no recurrence in imaging examination within 6-12 weeks after surgery, and need adjuvant therapy assessed by the researchers.\n* Laboratory tests must be met:\n* Neutrophils count =\u002F\\> 1.5 x 109\u002FL, platelets count =\u002F\\> 75 x 109\u002FL, Hb =\u002F\\> 90 g\u002FL, WBC =\u002F\\> 3 x 109\u002FL.\n* total bilirubin =\u002F\\\u003C 1.5 x ULN, ALT and AST =\u002F\\\u003C 2.5 x ULN.\n* Creatinine =\u002F\\\u003C 1.5 x ULN.\n* APTT, INR, PT =\u002F\\\u003C 1.5 x ULN.\n* TSH =\u002F\\\u003C ULN.\n* Myocardial enzymes in the normal range.\n* LVEF =\u002F\\> 50%.\n\nExclusion Criteria:\n\n* Patients received other antitumor adjuvant therapy after surgical resection.\n* Concurrent malignancy (except cured basal cell carcinoma of the skin).\n* Patients was diagnosed cervical esophageal carcinoma.\n* Patients who have received prior targeted therapy (anti-VEGF\u002FVEGFR) or immunity therapy (anti-PD-1\u002FPD-L1\u002FCTLA-4).\n* Patients who are allergic to other monoclonal antibodies.\n* Patients with a history of immunodeficiency (or active autoimmue disease), or other acquired congenital immunodeficiency diseases.\n* Immunosuppressant, systemic, or absorbable local hormone therapy (\\> 10mg\u002F day of prednisone or other equivalent hormone) is required for immunosuppression and continued within 2 weeks of initial administration.\n* Patients with multiple factors affecting oral administration.\n* Uncontrolled pleural effusion, pericardial effusion or ascites that requires repeated drainage.\n* With bleeding tendency. Patients with any bleeding or bleeding event CTC AE grade 3 in the 4 weeks prior to initial administration. The presence of digestive diseases or active bleeding of unresected tumors, or other conditions that the investigator determined which could lead to gastrointestinal bleeding or perforation.\n* Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments.\n* Patients with hypertension who could not be well controlled by antihypertensive drugs (systolic blood pressure \\> 160 mmHg, diastolic blood pressure \\> 100 mmHg).\n* Patients with myocardial infarction, myocardial ischemia, arrhythmias with poor control (including QTC interval male \\> 450 ms, female\\> 470 ms) and cardiac insufficiency of grade II according to NYHA standard.\n* Active or uncontrolled severe infection (≥ CTC AE Grade 2 infection).\n* HIV test positive.\n* Proteinuria =\u002F\\>2+ and confirmed 24-hour urinary protein quantification \\> 1.0 g.\n* Vaccination with prophylactic or attenuated vaccine within 4 weeks prior to initial administration.\n* According to the investigators' judgment, there are factors that endanger patient or prevent patients from completing the study.",{"count":172,"type":19},[65],"This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma (ESCC) Patients as Postoperative Adjuvant Therapy. In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with TQB2450 Injection in treatment of patients with ESCC. The primary endpoint is disease free survival (DFS).",[654,655,656,26,30,27,29,28,112,657,658],"Esophageal Squamous Cell Carcinoma","Esophageal Neoplasms","Esophageal Diseases","Neoplasms, Squamous Cell","Carcinoma, Squamous Cell","2022-12-14",{"date":661,"type":45},"2022-12-16",{"date":663,"type":45},"2022-06-02",{"date":665,"type":19},"2026-11",{"name":667,"class":161},"Jiangxi Provincial Cancer Hospital",""]