[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Melanoma Institute Australia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":224},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,51,85,112,133,164,188],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100596730","the-multicentre-selective-lymphadenectomy-trial---3-100596730",false,"NCT07049276","The Multicentre Selective Lymphadenectomy Trial - 3","Randomized Controlled Trial of Selective Index Lymph Node Resection Versus Therapeutic Lymph Node Dissection After Neoadjuvant Immunotherapy for Stage IIIB-D Melanoma","MSLT-3","Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age at the time of consent\n2. Written informed consent\n3. Cytologically or histologically confirmed, resectable pathological Stage IIIB, C or D (Any T, N1b, N2b, N2c, N3b, or N3c) cutaneous or unknown primary melanoma, with or without primary tumour in situ\n4. A minimum of one macroscopic lymph node, defined as:\n\n   * A palpable node, confirmed by pathology\n   * A non-palpable node, but enlarged per RECIST 1.1 criteria (≥ 15 mm in shortest diameter) and confirmed by pathology\n   * An ultrasound or PET\u002FCT scan positive lymph node of any size, confirmed by pathology.\n5. Up to 3 satellite (defined as any foci of clinically evident cutaneous and\u002For subcutaneous metastases occurring within 2 cm of but discontinuous from the primary melanoma) or in-transit metastases (defined as clinically evident cutaneous and\u002For subcutaneous metastases occurring \\>2 cm from the primary melanoma in the region between the primary and the regional lymph node basin) are permitted if they are completely resectable.\n6. Lymph node involvement in the groin (iliac, inguinal or both), axilla or neck only and may be unilateral or bilateral. Concurrent popliteal, epitrochlear or triangular intermuscular space (TIS) nodes permitted, as long as fully resectable.\n7. Tumour amenable to a newly obtained core biopsy of a lesion which has not been previously irradiated. Archival tissue from a past primary or nodal lesion (if applicable) or tissue taken for current diagnosis will also be collected if available.\n8. Systemic neoadjuvant immunotherapy is scheduled for administration with at least one PD-(L)-1 check point inhibitor (e.g. nivolumab, pembrolizumab, cemiplimab). The immunotherapy regimen may include other checkpoint inhibitors (e.g. ipilimumab, relatlimab, fianlimab). The patient should meet the fitness for treatment requirements as detailed in the relevant regulatory-approved Product Information or Summary of Product Characteristics.\n9. Neoadjuvant course of treatment to be no longer than 6 weeks (allows for a maximum of 3 cycles at weeks 0, 3 and 6).\n10. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n11. Anticipated life expectancy of \\> 5 years.\n\nExclusion Criteria:\n\n1. Uveal or mucosal melanoma.\n2. Isolated satellite or in-transit metastases only (without any cytological or histological proven lymph node involvement).\n3. Involvement of any lymph node basin other than groin, axilla or neck. Concurrent popliteal, epitrochlear or triangular intermuscular space (TIS) nodes permitted, as long as fully resectable.\n4. Clinical or radiographic evidence of distant metastasis (any AJCC 8th ed M Stage).\n5. Previous history of lymph node surgery to the same nodal basin, that was more extensive than a sentinel lymph node biopsy (SLNB).\n6. Previous radiotherapy to the same nodal basin.\n7. Any contraindication to the administration of nivolumab, ipilimumab, pembrolizumab or relatlimab per regulatory-approved product information and \u002F or medical oncologist.\n8. Prior anti-PD-1, CTLA-4, PDL-1 or LAG 3 antibody exposure, or an agent directed to another stimulatory or co-inhibitory T-cell receptor for any disease or any chemotherapy or experimental local or systemic drug treatment.\n9. A plan to administer targeted therapy or any non-checkpoint inhibitor immunotherapy, or any intralesional therapy for melanoma in the neoadjuvant setting.\n10. A plan to administer any experimental immunotherapy as part of a clinical trial in the neoadjuvant setting.\n11. Known additional malignancies (unless adequately treated) active within the previous 3 years, except for locally curable cancers that have been apparently cured. The following malignancies, if undergone successful definitive resection or curative treatment, are permitted:\n\n    * Basal cell carcinoma of the skin\n    * Squamous cell carcinoma of the skin\n    * Carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ, but excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy\n    * Prostatic intraepithelial neoplasia\n    * In situ melanoma\n    * Atypical melanocytic hyperplasia\n    * Stage I melanoma\n    * Other malignancies for which the patient has been disease free for 3 years, not requiring active anti-cancer therapy.\n12. An active autoimmune disease or a requirement for chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of study treatment. The following are permitted:\n\n    * Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc)\n    * Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient is on a stable dose\n    * Non-absorbed intra-articular steroid injections.\n13. Has had an allogenic tissue\u002Fsolid organ transplant.\n14. Active Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n15. Has a known history of Human Immunodeficiency Virus (HIV). Note: no testing for HIV is required unless mandated by local health authority.\n16. Pregnant or breastfeeding females.\n17. Concurrent medical or social conditions that may prevent the patient from attending assessments or procedures per schedule.","ALL","18 Years",{"count":20,"type":21},1500,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to demonstrate that there is no difference (non-inferiorty) in the 2 year recurrence-free survival (RFS) between 2 different surgical approaches for clinical Stage III melanoma. Following 6 weeks of standard neaodjuvant immunotherapy, patients will undergo either selective index lymph node resection (ILN) (identified at baseline as the largest affected lymph node) or the standard of care therapeutic lymph node dissection (TLND). The secondary aims are to assess if patients who are managed without TLND will have a reduction in surgical complications (less wound problems \\& lymphoedema), an improved quality of life, at a lower healthcare utilisation.",[27],"Cutaneous Melanoma, Stage III",[29,30,31,32,33,34,35,36,37],"Neoadjuvant","Non-inferiority","Randomised controlled trial","Adverse events","Quality of life","Healthcare economics","Index lymph node resection","Therapeutic lymph node dissection","Surgical morbidity","RECRUITING","2026-06-25",{"date":41,"type":42},"2026-06-29","ACTUAL",{"date":44,"type":42},"2025-10-01",{"date":46,"type":21},"2040-08",{"name":48,"class":49},"Melanoma Institute Australia","OTHER",8,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100575055","phase-2-stereotactic-ablative-radiotherapy-xrt-and-immunotherapy-for-oligometastatic-extracranial-melanoma-100575055","NCT06767306","Stereotactic Ablative Radiotherapy (XRT) and Immunotherapy for Oligometastatic Extracranial Melanoma","A Phase II, Multicentre, Non-Comparative, Randomised Controlled Trial of Stereotactic Ablative Body Radiotherapy and Immunotherapy Versus Immunotherapy Alone in Patients With Treatment Naïve Oligometastatic Extracranial Melanoma","AXIOM","Inclusion Criteria:\n\n* Female or male patients, age 18 or older\n* Willing to provide signed informed consent\n* Life expectancy \\> 6 months\n* First presentation of AJCC Stage IV (any N, M1a, M1b, M1c), histologically confirmed cutaneous, acral or unknown primary melanoma with one to five extracranial metastases detected on CT and whole body PET-CT, and considered unresectable\n* A primary lesion and \u002F or up to 4 in-transit metastases(is) (ITM) in addition to distant metastases(is) are permitted and will be counted in the maximum number of permitted baseline lesions\n* Prior surgery for symptomatic disease (e.g. small bowel obstruction) for this first presentation of Stage IV melanoma is permitted, provided the total number of remaining extracranial metastases is ≤ 5 (NOT including the resected lesion). No more than one excised metastatic lesion is permitted\n* At least one metastasis should be measurable as a target lesion per RECIST version 1.1\n* No evidence of cerebral metastases on MRI brain (CT brain is acceptable if there is contraindication to MRI)\n* All lesions can be treated with a minimum SBRT biologically effective dose (BED) of 48Gy\n* Able to tolerate treatment with immunotherapy as determined by the medical oncologist\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of randomisation\n\nExclusion Criteria:\n\n* Ocular or mucosal melanoma\n* Serious or unstable medical co-morbidities or other conditions that could interfere with the patient's safety, consent, or compliance\n* Patients for whom there is a definite and immediate indication for radiotherapy (e.g., spinal cord compression, rapidly progressing disease associated with clinical signs and symptoms)\n* Prior radiotherapy for Stage IV disease (prior adjuvant radiotherapy to primary site or nodal field (Stage I-III disease) is permitted, however adjuvant-treated sites must not be included in the baseline lesions\n* Inability to treat all disease sites with SBRT as determined by radiation oncologist\n* Prior systemic drug therapy for melanoma, unless given in the neoadjuvant or adjuvant setting for Stage I-III disease\n* Any contraindication to the planned standard of care immunotherapy regimen per regulatory approved product information\n* For patients with liver metastases - moderate\u002Fsevere liver dysfunction\n* A known history of another malignancy or concurrent malignancy unless the patient is disease-free for a minimum of 1 year, is completely treated and is at low risk of recurrence\n* Pregnant or breastfeeding females",{"count":60,"type":21},129,[62],"PHASE2","The purpose of this research is to evaluate the addition of radiotherapy to the standard immunotherapy drugs that are given to patients with advanced or metastatic melanoma that has spread to other parts of the body. Radiotherapy uses x-rays to target and kill melanoma cells and immunotherapy works by activating the body's own immune system to seek out and fight melanoma cells. Both of these treatments are commonly given to patients with advanced melanoma and other cancers. Both treatments are usually given separately but can also be given together. The aim of this research is to find out if giving radiotherapy and immunotherapy together is better than giving immunotherapy alone.\n\nThe type of radiotherapy to be used in this project is known as 'stereotactic' body radiotherapy or SBRT (also known as stereotactic body ablative radiotherapy, SABR). SBRT targets the radiation very precisely at the metastatic deposits in the body. This method protects the healthy areas near the melanoma. SBRT works by delivering a high dose of radiation precisely to the areas of melanoma which causes the melanoma cells to break apart and eventually die. SBRT is given in 'fractions' which means the high dose is given in small measures over several days, depending on the number and size of metastases.",[65],"Melanoma Metastatic",[67,68,69,70,71,72,73,74,33,75],"SABR","stereotactic body radiotherapy","Stereotactic Ablative Body Radiotherapy","SABRT","Immunotherapy","Immune Checkpoint Inhibitors","Oligometastases","Extracranial","Biomarkers","2026-05-03",{"date":78,"type":42},"2026-05-07",{"date":80,"type":42},"2025-03-06",{"date":82,"type":21},"2033-04-01",{"name":48,"class":49},5,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100592941","phase-2-neo-irenie-neoadjuvant-ipilimumab-relatlimab-nivolumab-evaluation-100592941","NCT06999980","Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)","A Phase II, Multicentre, Parallel Group, Open Label, Randomised Clinical Trial of Neoadjuvant Nivolumab and Ipilimumab Combined With Relatlimab for Patients With Resectable Advanced Melanoma Identified as Poor Responders to Immunotherapy","Neo IRENIE","COMMON Inclusion Criteria Applicable to all 3 cohorts\n\nInclusion Criteria:\n\n* 1\\. Written informed consent\n* 2\\. Male or female patients who are at least 18 years of age on the day of signing informed consent.\n* 3\\. Clinically detectable disease, and\u002For RECIST version 1.1 defined disease, and\u002For disease confirmed on PET imaging.\n* 4\\. Fully resectable disease defined as having no significant vascular, central nervous system or bony involvement. Only cases where a complete surgical resection leading to tumour free margins and which is safely achieved is considered \"resectable\".\n* 5\\. Concurrent primary disease and lymph node metastases acceptable provided completely resectable.\n* 6\\. Up to 3 in-transit metastases are permitted as long as these are fully resectable.\n* 7\\. Tumour that is amenable to a newly obtained core biopsy for performance of the multi-omic predictive biomarker model\n* 8\\. ECOG performance status of 0 to 1.\n* 9\\. Adequate haematological, hepatic, renal and endocrine function\n* 10\\. An anticipated life expectancy of \\>12 months.\n* 11\\. Women of child bearing potential (WOCBP) must agree to avoid pregnancy or breast feeding for the duration of study treatment.\n\nInclusion Criteria - Cohort 1 only\n\n* a. Histologically confirmed diagnosis of cutaneous melanoma or unknown primary melanoma\n* b. AJCC 8th Ed Stage IIIB, IIIC, IIID cutaneous melanoma\n* c. No prior systemic treatment for cutaneous melanoma\n* d. Completion of the multi-omic predictive biomarker model within 14 days (7-10 business days) of planned randomisation.\n\nInclusion Criteria - Cohort 2 only\n\n* a. Histologically confirmed diagnosis of cutaneous melanoma or unknown primary melanoma\n* b. AJCC 8th Ed Stage IIIB, IIIC, IIID cutaneous melanoma\n* c. Disease progression on neoadjuvant anti-PD-1 monotherapy, where progressed disease is completely resectable or, disease recurrence on adjuvant anti-PD-1 monotherapy, where recurrent disease is completely resectable\n* d. No prior treatment with CTLA-4 or LAG-3 inhibitors.\n\nInclusion Criteria - Cohort 3 only\n\n* a. Histologically confirmed diagnosis of mucosal melanoma\n* b. Any stage of disease provided it is fully resectable\n* c. No prior systemic treatment for mucosal melanoma\n\nCOMMON Exclusion Criteria Applicable to all 3 cohorts\n\n* 1\\. Uveal melanoma\n* 2\\. Any contraindication to the administration of relatlimab, ipilimumab or nivolumab\n* 3\\. No prior systemic therapy, including treatment with prior anti-PD1\u002FL1, anti-CTLA-4 or anti-LAG-3 therapy (cohorts 1 and 3), except for cohort 2 which will have received anti-PD1 monotherapy only.\n* 4\\. A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days of randomisation. The following are permitted:\n\n  1. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc)\n  2. Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient is on a stable dose\n  3. Non-absorbed intra-articular steroid injections.\n* 5\\. An active autoimmune disease that has required systemic treatment in the past 12 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). The following are permitted:\n\n  1. Vitiligo\n  2. Type I diabetes mellitus\n  3. Residual autoimmune hypothyroidism on stable hormone replacement\n  4. Resolved childhood asthma or atopy\n  5. Psoriasis not requiring systemic treatment\n  6. Autoimmune conditions which are not expected to recur in the absence of an external trigger.\n* 6\\. A known additional malignancy that is progressing or has required active treatment within the past 3 years. The following malignancies, if undergone successful definitive resection or curative treatment, are permitted:\n\n  1. Basal cell carcinoma of the skin\n  2. Squamous cell carcinoma of the skin\n  3. Carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy)\n  4. Prostatic intraepithelial neoplasia\n  5. In situ melanoma\n  6. Atypical melanocytic hyperplasia\n  7. Multiple primary melanomas\n  8. Other malignancies for which the patient has been disease free for 1 year.\n* 7\\. A known CNS metastases and\u002For carcinomatous meningitis\n* 8\\. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis or current interstitial lung disease.\n* 9\\. Has an active infection requiring systemic therapy.\n* 10\\. Has a known history of Human Immunodeficiency Virus (HIV). Note: no testing for HIV is required unless mandated by local health authority.\n* 11\\. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* 12\\. Has a known history of active TB (Bacillus Tuberculosis).\n* 13\\. Uncontrolled or significant cardiovascular disease including, but not limited to any of the following:\n\n  1. Myocardial infarction (MI) or stroke\u002Ftransient ischemic attack within the 6 months prior to consent\n  2. Uncontrolled angina within the 3 months prior to consent\n  3. Any history of clinically significant arrhythmias (such as poorly controlled atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or torsades de pointes)\n  4. QTc prolongation \\> 480 ms\n  5. History of other clinically significant cardiovascular disease (i.e. cardiomyopathy, congestive heart failure with New York Heart Association functional classification III-IV, pericarditis, significant pericardial effusion, significant coronary stent occlusion, poorly controlled venous thrombosis, etc)\n  6. Cardiovascular disease-related requirement for daily supplemental oxygen\n  7. History of 2 or more M.I.s OR 2 or more coronary revascularisation procedures (regardless of the number of stent placements during each procedure)\n  8. Patients with history of myocarditis, regardless of aetiology.\n* 14\\. Patients with a \\>1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \\\u003C1 g\u002F24 hours.\n* 15\\. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n* 16\\. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* 17\\. Pregnant or breast feeding females\n* 18\\. Concurrent medical or social conditions that may prevent the patient from attending assessments per schedule",{"count":94,"type":21},494,[62],"This clinical trial is for patients with stage 3 cutaneous melanoma and patients with mucosal melanoma who are able to have surgery to remove all tumour deposits. To improve the chance that melanoma will not recurr, new experimental combinations of a type of treatment called immunotherapy will be given before surgery.",[98,99],"Cutaneous Melanoma","Mucosal Melanoma",[29,71,101,102],"Randomised trial","Low Responder","2026-02-18",{"date":105,"type":42},"2026-02-19",{"date":107,"type":42},"2026-02-09",{"date":109,"type":21},"2038-01",{"name":48,"class":49},1,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":111},"100527705","phase-2-neoadjuvant-nivolumab-and-relatlimab-in-merkel-cell-carcinoma-100527705","NCT06151236","Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma","A Phase 2, Open Label, Single Arm Clinical Trial of Neoadjuvant Nivolumab and Relatlimab in Stage I To III Resectable Merkel Cell Carcinoma","Inclusion Criteria:\n\n1. Aged ≥ 18 years\n2. Written consent\n3. Histologically confirmed, resectable Merkel cell carcinoma with AJCC (8th ed) clinical or pathological stage I (≥ 10 mm), IIA, or IIB or III disease\n4. In-transit metastases are permitted if they are completely resectable\n5. Measurable disease according to RECIST 1.1 criteria\n6. Previous radiotherapy permitted if there is RECIST-measurable progression of disease since the completion of radiotherapy\n7. At least one of either, archival tissue from a primary or nodal MCC lesion (if applicable) for the current diagnosis and\u002For a newly obtained core biopsy of a lesion which has not been previously irradiated.\n8. ECOG 0-1\n9. Adequate organ function on blood pathology\n10. Life expectancy \\>12 months\n11. Female patients to use effective contraception during study treatment and for 5 months after last dose.\n\nExclusion Criteria:\n\n1. Clinical, radiographic or pathological evidence of distant metastases\n2. Contraindication to nivolumab and \u002F or relatlimab\n3. Prior anti-PD-1, CTLA-4, PDL-1 or LAG 3 antibody exposure, or an agent directed to another stimulatory or co-inhibitory T-cell receptor for any disease or any chemotherapy or experimental local or systemic drug treatment\n4. Active autoimmune disease or requirement for chronic steroid therapy other than hormone replacement therapy\n5. A diagnosis of immunodeficiency or chronic steroid therapy \\>10 mg OD prednisone or equivalent\n6. Additional malignancy active within past 3 years; patients with chronic lymphocytic leukaemia can be included in this study.\n7. Uncontrolled cardiovascular disease or history of myocarditis\n8. Has had an allogenic tissue\u002Fsolid organ transplant\n9. Troponin T (TnT) or I (TnI) \\>2 × institutional ULN\n10. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis or current interstitial lung disease\n11. Has an active infection requiring systemic therapy\n12. Active Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n13. Known HIV\n14. Pregnant or breast feeding females\n15. Concurrent medical or social conditions that may prevent the patient attending assessments or procedures per schedule",{"count":120,"type":21},20,[62],"The goal of this clinical trial is to test neoadjuvant dual immunotherapy in Merkel cell carcinoma with the aim to improve recurrence-free survival",[124],"Merkel Cell Carcinoma","2026-02-12",{"date":127,"type":42},"2026-02-17",{"date":129,"type":42},"2024-03-11",{"date":131,"type":21},"2034-04",{"name":48,"class":49},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100311875","phase-2-anti-pd-1-brain-collaboration--radiotherapy-extension-abc-x-study-100311875","NCT03340129","Anti-PD 1 Brain Collaboration + Radiotherapy Extension (ABC-X Study)","A Phase II, Open Label, Randomised, Controlled Trial of Ipilimumab and Nivolumab With Concurrent Intracranial Stereotactic Radiotherapy Versus Ipilimumab and Nivolumab Alone in Patients With Melanoma Brain Metastases.","ABC-X","Inclusion Criteria:\n\n1. Female or male patients, ≥18 years of age.\n2. Signed, written, informed consent.\n3. AJCC Stage IV \\[any T, any N, M1d (0) or M1D(1)\\] histologically confirmed cutaneous, acral or mucosal unresectable melanoma or unknown primary melanoma and at least 1 radiological definitive brain metastasis that is ≥ 5mm and ≤40mm, measurable per RECIST version 1.1 guidelines (modified for brain metastases, enabling up to 5 target lesions in the brain as well as up to 5 extracranial target lesions). There is no upper limit restriction in the number of brain metastases, provided the remaining eligibility criteria are met.\n4. The BRAF mutation status must be available prior to randomisation.\n5. The treating clinician(s) should consider the intracranial disease amenable to stereotactic radiotherapy over whole brain radiotherapy. Patients for whom there is a definite and immediate indication for radiotherapy (e.g. rapidly progressing disease with associated clinical signs and \u002For symptoms) should not be considered for enrolment.\n6. Brain metastases must be untreated with any modality of radiotherapy or systemic treatment. Previous surgery for melanoma brain metastases is permitted if it resulted in gross total resection and no radiotherapeutic cavity boost was required.\n7. No prior systemic treatment for brain metastases is permitted unless given in the neoadjuvant or adjuvant settings for systemic drug the treatment for extracranial disease only. At the time of neoadjuvant or adjuvant systemic therapy for extracranial disease, there should be radiological evidence of the absence of brain metastases. The presenting diagnosis of brain metastases at the time of enrolment in this study must have occurred a minimum of 6 months after stopping neoadjuvant or adjuvant systemic therapy (prior anti PD1, anti PD-L1, anti CTLA-4, BRAF \u002F MEK inhibitors or clinical trial agents) are acceptable in the setting of neoadjuvant or adjuvant treatment\n8. Asymptomatic from brain metastases at the time of study enrolment without corticosteroids, analgesia or any other treatment for the management of neurological symptoms (with the exception of antiepileptics prescribed for any reason, provided patient is asymptomatic). Resolved neurological symptoms are permitted if complete resolution, without any intervention, has been sustained for a minimum of 7 days prior to randomisation.\n9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n10. A life expectancy \\> 30 days.\n11. Able to undergo MRI with Gadolinium contrast agent. CT of the brain is not an acceptable alternative should patients be unable to safely undergo a contrast MRI.\n12. Adequate haematological, hepatic and renal organ function as defined by:\n\n    1. White cell count ≥ 2.0 × 10x9\u002FL\n    2. Neutrophil count ≥ 1.5 × 10x9\u002FL\n    3. Haemoglobin ≥ 90 g\u002FL\n    4. Platelet count ≥ 100 x 10x9\u002FL\n    5. Total bilirubin ≤ 1.5 x ULN\n    6. Alanine transaminase ≤ 3.0 x ULN\n    7. Aspartate aminotransferase ≤ 3.0 x ULN\n    8. Serum creatinine ≤ 1.5 x the upper limit of normal (ULN). If serum creatinine is \\> 1.5 x ULN, calculate creatinine clearance using standard Cockcroft-Gault formula. Creatinine clearance must be 40ml\u002Fmin to be eligible.\n13. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of the first dose of study treatment and agree to use effective contraception from 14 days prior to commencing study treatment, throughout the treatment period and for 23 weeks \\* after the last dose of study treatment. Effective contraception includes:\n\n    1. Intrauterine device with a documented failure rate of less than 1% per year.\n    2. Vasectomised partner who is sterile prior to the female partner patient's commencement of study treatment and is the sole sexual partner for that female.\n    3. Combined (oestrogen and progestogen) hormonal contraception associated with inhibition of ovulation or progestogen only hormonal contraception associated with inhibition of ovulation.\n\nWomen who are not of childbearing potential are defined as any female who has had a documented hysterectomy, bilateral oophorectomy or bilateral tubal ligation or any female who is post-menopausal (≥ one year without menses and \\>50 years of age in the absence of hormone replacement therapy).\n\n\\* These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days.\n\nExclusion Criteria\n\n1. Patients whose intracranial disease changes between the diagnostic MRI scan and the baseline \u002F SRS planning MRI scan and who are no longer suitable for SRS and \u002F or require a specific alternative treatment outside of this protocol.\n2. Melanoma brain metastasis greater than 40mm.\n3. Evidence of leptomeningeal disease, with the exception of pathological findings seen at a previous resection of brain disease, but with no evidence of leptomeningeal disease elsewhere at the time of resection or at study entry.\n4. History of, or current ocular melanoma (patients with mucosal and acral melanoma are eligible).\n5. Neurological symptoms from brain metastases present at baseline (resolved neurological symptoms, prior to enrolment, are permitted).\n6. Prior radiotherapy to the brain (surgery permitted).\n7. Prior systemic drug therapy for melanoma, unless given in the neoadjuvant or adjuvant setting and completed 6 months before enrolment in this study.\n8. Patients with active, known or suspected autoimmune disease. Patients with the following are permitted to enrol:\n\n   1. Vitiligo\n   2. Type I diabetes mellitus\n   3. Residual hypothyroidism due to an autoimmune condition only requiring hormone replacement\n   4. Psoriasis not requiring systemic treatment\n   5. Autoimmune conditions not expected to recur in the absence of an external trigger.\n9. Current systemic treatment with corticosteroids, or within 7 days of randomisation, with the exception of prednisone at non-immunosuppressive doses of ≤ 10 mg\u002Fday (or equivalent, e.g. e.g. prednisone 10mg = dexamethasone 1.6mg = hydrocortisone 40mg). Patients with the following circumstances are permitted to enrol:\n\n   1. Past treatment for non-neurological symptoms allowed, if this was ceased 7 days prior to randomisation\n   2. Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if the patient is on a stable dose\n   3. Non-absorbed intra-articular steroid injections.\n\n   During the study, treatment with systemic corticosteroids is permitted during radiotherapy if the patient experiences radiation related symptoms but this should be tapered per standard clinical practice as soon as possible and before the next infusion of study drug is due. This also refers to steroids for drug related signs or symptoms.\n10. Any active infection requiring treatment.\n11. A history of interstitial lung disease.\n12. Any concurrent malignancy requiring any treatment or a history of another malignancy, unless the patient has been disease-free for 3 years.\n13. Serious or unstable pre-existing medical conditions or other conditions that could interfere with the patient's safety, consent, or compliance.\n14. Pregnant or breastfeeding females.\n15. Administration of any form of live vaccine within 30 days of starting the trial and during the trial. Administration of any other vaccine is cautionary within 30 days of starting the trial and for the duration of the treatment phase of the trial.\n16. Hypersensitivy to study treatments.","120 Years",{"count":143,"type":21},218,[62],"This is a phase II, open label, randomised trial of ipilimumab and nivolumab with concurrent intracranial stereotactic radiotherapy versus ipilimumab and nivolumab alone in patients with asymptomatic, untreated melanoma brain metastases.",[147],"Melanoma Stage Iv",[71,149,150,151,152,153,154],"Radiotherapy","Brain metastases","Stereotactic radiotherapy","Stereotactic radiosurgery","Cognitive function","Neurological-specific cause of death","2026-01-29",{"date":157,"type":42},"2026-02-02",{"date":159,"type":42},"2019-08-14",{"date":161,"type":21},"2029-08",{"name":48,"class":49},9,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":111},"100538235","phase-2-neoadjuvant-nivolumab-and-relatlimab-in-cutaneous-squamous-cell-carcinoma-100538235","NCT06288191","Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma","A Phase 2, Open Label, Single Arm, Clinical Trial of Neoadjuvant Nivolumab and Relatlimab in Stage II To IV (M0) Resectable Cutaneous Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. ≥ 18 years of age\n2. Written informed consent\n3. Histologically confirmed, resectable stage II to IV cutaneous squamous cell carcinoma defined as:\n\n   Non-head and neck cuSCC:\n   1. stage II (T2, N0, M0)\n   2. stage III (T3, N0, M0; or T1-3, N1, M0)\n   3. stage IV (T1-3, N2 or N3, M0; or T4a or T4b, any N, M0)\n\n   Cutaneous head and neck CC:\n   1. stage II (T2, N0, M0)\n   2. stage III (T3, N0, M0)\n   3. stage IV (T4a or T4b, any N, M0)\n4. In-transit metastases (ITM) are permitted if they are completely resectable. ITM defined as skin or subcutaneous metastases that are \\> 20 mm from the primary lesion but not beyond the regional nodal basin.\n5. Measurable disease according to RECIST version 1.1 criteria (≥10 mm longest diameter for primary lesions and \u002F or ≥10 mm in shortest diameter for lymph nodes as determined by CT imaging) within 2 weeks of the start of study treatment.\n6. Tumour amenable to a newly obtained core biopsy of a lesion which has not been previously irradiated. Archival tissue from a past primary or nodal cuSCC lesion (if applicable) or tissue taken for current diagnosis will also be collected.\n7. Previous radiotherapy permitted if performed at a prior site of disease not seen at baseline.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n9. Documented adequate haematological, hepatic, renal, and thyroid function determined by blood pathology\n10. Anticipated life expectancy of \\> 12 months\n11. Women of childbearing potential must have a negative serum pregnancy test within 24 hours of the first dose of study treatment or within 72 hours if this is not feasible. Effective contraception should be used for the duration of study treatment and for 5 half-lives (or 5 months) after the last dose. Egg donation (ova, oocytes) should be avoided for the same period. There are no partner-pregnancy or sperm donation avoidance requirements for male patients.\n\nExclusion Criteria:\n\n1. Clinical or radiographic evidence of distant metastasis\n2. SCC of the eyelid, vulva, penis and perianus\n3. Any contraindication to the administration of nivolumab and \u002F or relatlimab\n4. Prior anti-PD-1, CTLA-4 (Cytotoxic T-lymphocyte associated protein 4), PDL-1 (Programmed death-ligand 1) or LAG 3 (Lymphocyte-Activation Gene 3) antibody exposure, or an agent directed to another stimulatory or co-inhibitory T-cell receptor for any disease or any chemotherapy or experimental local or systemic drug treatment\n5. Active autoimmune disease or a requirement for chronic steroid therapy other than hormone replacement therapy\n\n   The following are permitted:\n   * Vitiligo\n   * Type I diabetes mellitus on stable insulin therapy\n   * Residual autoimmune hypothyroidism on stable hormone replacement\n   * Resolved childhood asthma or atopy\n   * Psoriasis not requiring systemic treatment\n   * Autoimmune conditions which are not expected to recur in the absence of an external trigger.\n6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of study treatment.\n\n   The following are permitted:\n   * Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.)\n   * Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient is on a stable dose\n   * Non-absorbed intra-articular steroid injections.\n7. Known additional malignancies (unless adequately treated) active within the previous 3 years, except for locally curable cancers that have been apparently cured.\n\n   The following malignancies, if undergone successful definitive resection or curative treatment, are permitted:\n   * Basal cell carcinoma of the skin\n   * Squamous cell carcinoma of the skin\n   * Carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ, but excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy\n   * Prostatic intraepithelial neoplasia\n   * In situ melanoma\n   * Atypical melanocytic hyperplasia\n   * Multiple primary melanomas\n   * Other malignancies for which the patient has been disease free for 3 years, not requiring active anti-cancer therapy.\n8. Uncontrolled or significant cardiovascular disease including, but not limited to any of the following:\n\n   * Myocardial infarction (MI) or stroke\u002Ftransient ischemic attack within the 6 months prior to consent\n   * Uncontrolled angina within the 3 months prior to consent\n   * Any history of clinically significant arrhythmias (such as poorly controlled atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or torsades de pointes)\n   * QTc (corrected QT interval) prolongation \\> 480 ms\n   * History of other clinically significant cardiovascular disease (i.e. cardiomyopathy, congestive heart failure with New York Heart Association functional classification III-IV, pericarditis, significant pericardial effusion, significant coronary stent occlusion, poorly controlled venous thrombosis, etc)\n   * Cardiovascular disease-related requirement for daily supplemental oxygen\n   * History of 2 or more M.I.s OR 2 or more coronary revascularisation procedures (regardless of the number of stent placements during each procedure)\n   * Patients with history of myocarditis, regardless of aetiology.\n9. Troponin T (TnT) or I (TnI) \\>2 × institutional ULN (upper limit of normal). Participants with TnT or TnI levels between \\>1 to 2 × ULN will be permitted if repeat levels within 24 hours are ≤1 ULN. If TnT or TnI levels are between \\>1 to 2 × ULN within 24 hours, the participant may undergo a cardiac consultation and be considered for treatment, following cardiologist recommendation. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \\\u003C2 × ULN, the participant may undergo a cardiac consultation and be considered for treatment, following cardiologist recommendation. Notification of the decision to enrol the participant following cardiologist recommendation must be made to the Lead Investigator.\n10. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis or current interstitial lung disease.\n11. Has an active infection requiring systemic therapy.\n12. Has had an allogenic tissue\u002Fsolid organ transplant\n13. Has a known history of Human Immunodeficiency Virus (HIV). Note: no testing for HIV is required unless mandated by local health authority.\n14. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n15. Pregnant or breast-feeding females\n16. Concurrent medical or social conditions that may prevent the patient from attending assessments per schedule.",{"count":120,"type":21},[62],"The goal of this study is to test neoadjuvant therapy with the dual inhibition of Programmed cell death protein 1 (PD-1) and lymphocyte activation gene 3 (LAG-3) immune checkpoint pathways in a cohort of treatment-naïve, resectable stage II to IV cutaneous squamous cell carcinoma on the pathological response rate (pCR) and recurrence-free survival.",[175],"Cutaneous Squamous Cell Carcinoma",[177,178,179],"neoadjuvant","immunotherapy","pathological response","2025-12-08",{"date":182,"type":42},"2025-12-16",{"date":184,"type":42},"2024-06-21",{"date":186,"type":21},"2036-07",{"name":48,"class":49},{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":198,"phases":4,"briefSummary":199,"conditions":200,"keywords":204,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},"100557295","personalised-immunotherapy-platform-100557295","NCT06536257","Personalised Immunotherapy Platform","Personalised Immunotherapy Platform (PIP) - Implementation of a Predictive Model of Response to Immunotherapies in Melanoma","PIP-PREDICT","MELANOMA:\n\nInclusion Criteria:\n\n1. Written informed consent to participation for the use of tumour tissue, blood and stool and collection of standard clinical data.\n2. Histologically confirmed resected stage II (at high risk of recurrence of disease), III or stage IV melanoma (including cutaneous, mucosal, acral, subungual, uveal or unknown primary melanoma) and unresectable Stage III or IV melanoma\n3. Eligible to receive immunotherapy\n4. Availability of a melanoma tissue sample which was obtained at surgery and where no systemic treatments (e.g. adjuvant treatment) were administered between sample procurement and proposed PIP testing\n5. Patients who have received adjuvant or neoadjuvant systemic therapy in the past are eligible if they have had recurrence after neoadjuvant or adjuvant therapy has been completed and the biopsy represents this relapsed disease\n6. RECIST version 1.1 measurable disease.\n7. Tissue sample must be representative of the whole tumour and therefore excision biopsies are preferred over core biopsies.\n8. A life expectancy over 6 months.\n9. Prior treatment with BRAF (B-Raf proto-oncogene) \u002F MEK (mitogen-activated protein kinase) inhibitors are acceptable, providing the other eligibility criteria are met.\n10. If a patient has had prior radiotherapy for melanoma, the biopsy to be used for the biomarker test must be from an area that was not within the radiotherapy field.\n\nExclusion Criteria:\n\n1\\. Patients will be excluded if they have had a positive test result for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection. If receiving treatment and from HCV for at least one year, patients are allowed to participate. No new testing is required for the sole purpose of this pilot phase. Patients will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). No new testing is required\n\nNON-MELANOMA:\n\nInclusion Criteria:\n\n1. Written informed consent to participation for the use of tumour tissue and collection of standard clinical data\n2. Histologically confirmed cancer and eligibility to receive immunotherapy treatment.\n3. Availability of a tissue sample where no systemic treatments were administered between sample procurement and proposed PIP testing\n4. If treatment has been administered since the last tissue sample was obtained, a new biopsy should be planned for routine testing or clinical trial screening, where a portion of the sample can be used for the predictive assay. No new biopsies are required for the sole purpose of this study.\n5. Patients who have received adjuvant or neoadjuvant systemic therapy in the past are eligible if they have had recurrence after neoadjuvant or adjuvant therapy has been completed and the biopsy represents this relapsed disease.\n6. Have clinically detectable disease defined as one of more of the following:\n\n   * RECIST measurable. Lesions situated in a previously irradiated area are considered measurable if RECIST-defined disease progression since radiotherapy has been demonstrated in such lesions, OR,\n   * Positron Emission Tomography (PET) avid, OR,\n   * Clinically evident disease: photographically, detectable on CT or palpable, OR\n   * Clinical status measured by observable and diagnosable signs or symptoms.\n7. The tissue sample must be representative of the whole tumour and therefore excision biopsies are preferred over core biopsies.\n8. A life expectancy over 6 months.\n9. Prior treatment with targeted therapies are acceptable, providing the other eligibility criteria are met.\n10. If a patient has had prior radiotherapy for melanoma, the biopsy to be used for the biomarker test must be from an area that was not within the radiotherapy field\n\nExclusion Criteria:\n\n1\\. Patients will be excluded if they have had a positive test result for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection. If receiving treatment and from HCV for at least one year, patients are allowed to participate. No new testing is required for the sole purpose of this pilot phase. Patients will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). No new testing is required",{"count":197,"type":21},1000,"OBSERVATIONAL","This is a non-interventional study to prospectively test a suite of predictive biomarker models of immunotherapy resistance in patients with melanoma, non-melanoma skin cancers and other solid tumours. The study will evaluate the documentation, processes, accuracy and utility of the predictive biomarker model in clinical practice.",[201,175,202,124,203],"Melanoma","Basal Cell Carcinoma","Solid Tumor",[205,206,71,207,208,209,210,211,212,213,214],"Biomarker","Predictive","Multi-omic","Tumour mutation burden","Gene expression","Tissue imaging","Machine learning","Multiplex immunofluorescence","Immune checkpoint inhibitors","Quantitative pathology","2025-09-12",{"date":217,"type":42},"2025-09-18",{"date":219,"type":42},"2021-06-08",{"date":221,"type":21},"2037-06-01",{"name":48,"class":49},3,""]