[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"melanoma-skin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:melanoma-skin":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,44,76,100,120,140,171,198,221,242,274,299,328,352,380,410,441,464,489],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100539045","high-intensity-exercise-and-high-fiber-diet-for-immunotherapy-outcomes-in-melanoma-patients-the-duo-trial-100539045",false,"NCT06298734","High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial","Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically diagnosed with melanoma.\n* Having been or newly receiving immunotherapy for at least one month.\n* Having a plan to continue immunotherapy for at least 8 weeks at the time of recruitment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, indicating the ability to fulfill physical fitness and function assessments.\n* Ability to understand and willingness to provide informed consent.\n\nExclusion Criteria:\n\n* Participating in ≥ 150 minutes of moderate-to-vigorous aerobic exercise per week over the past month.\n* Consuming ≥ 30 grams\u002Fday of dietary fiber over the past month.\n* Having chronic medical conditions that are clinically unstable or uncontrolled with medications, deemed high-risk for exercise. These include but are not limited to unstable cardiac diseases, uncontrolled diabetes, and bone metastases with imminent risk of fracture.\n* Having a high risk for noncompliance with study procedures. This will be determined by the study team based on the history of missed oncology appointments (i.e., ≥3 no-shows in 6 months) and poor responsiveness during recruitment (i.e., ≥3 unreturned contacts).\n* Patients who are non-English speaking and cannot complete the participant surveys.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this study is to determine whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among participants with advanced melanoma receiving immunotherapy.\n\nThe names of the groups in this research study are:\n\n* High-Intensity Exercise (EX)\n* High-fiber Diet (DT)\n* Combined High-Intensity Exercise and High-Fiber Diet (COMB)\n* Attention Control (AC)",[26,27,28],"Melanoma (Skin)","Skin Cancer","Advanced Melanoma",[30,27,28],"Melanoma","RECRUITING","2026-06-15",{"date":34,"type":35},"2026-06-17","ACTUAL",{"date":37,"type":35},"2024-07-01",{"date":39,"type":20},"2027-03-31",{"name":41,"class":42},"Fred Hutchinson Cancer Center","OTHER",2,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":43},"100549893","rural-adult-and-youth-sun-protection-study-100549893","NCT06439979","Rural Adult and Youth Sun Protection Study","Rural Adult and Youth Sun Protection Study - Rural Baseball R01","RAYS","Parent inclusion criteria:\n\ni. Adults who currently have children ages 3 and older years of age playing on participating sports teams in leagues serving rural areas in Utah or West Virginia (rural is defined as ≥4 by the RUCA or RUCC systems)\n\nii. Live and\u002For work in rural communities in Utah or West Virginia (≥4 as defined by the RUCA or RUCC systems)\n\nCoach\u002Fleader inclusion criteria:\n\ni. Adults who serve as coaches or leaders of recreational sports (i.e. baseball\u002Fsoftball, soccer, flag football, etc.) teams or developmental programs serving children ages 3 and older\n\nii. Live and\u002For work in rural areas of Utah or West Virginia (rural is defined as ≥4 by the RUCA or RUCC systems)\n\nParticipant inclusion criteria for minor participants (ages 3 and older) are as follows:\n\ni. Live in rural communities and\u002For participate in sports leagues serving rural communities in Utah or West Virginia (≥4 as defined by the RUCA or RUCC systems).\n\nParticipant inclusion criteria for key informant interviews are as follows:\n\ni. Adults who serve as leaders or who are affiliated with sports leagues or community groups serving rural youths and\u002For adults who currently have minor children 3 years of age or older playing on participating sports teams and\u002For adults who live and\u002For work in rural communities in Utah or West Virginia ((≥4 as defined by the RUCA or RUCC systems)\n\nLocal sports leagues will be eligible to participate if they convene recreational sports (i.e. baseball\u002Fsoftball) teams or developmental programs (i.e. T-ball and coach pitch) for children ages 3 and older.\n\nExclusion Criteria:\n\n* Adults and children who do not speak or read English will be excluded.\n* For individuals asked to complete surveys, individuals who have a medical or other condition (e.g., developmental delay) that would preclude their completion of these surveys will be excluded.",true,"3 Years","7 Years",{"count":56,"type":20},843,[23],"The purpose of this study is to help prevent skin cancer by improving the use of sun protective behaviors among youths living in rural communities in Utah and West Virginia.",[26,27],[61,62,63,64,65,66],"Rural","Melanoma, Skin cancer","Prevention","Underserved communities","Youth","Sports","2026-06-10",{"date":69,"type":35},"2026-06-12",{"date":71,"type":35},"2024-04-08",{"date":73,"type":20},"2030-04",{"name":75,"class":42},"University of Utah",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100633487","phase-2-fianlimabcemiplimab-as-totalneoadj-the-tnt-formelanoma-100633487","NCT07527325","Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma","Fianlimab and Cemiplimab as Total Neoadjuvant Therapy (TNT) For Melanoma","Inclusion Criteria:\n\n* ≥18 years at the time of signing informed consent form (ICF) and able to independently complete informed consent. A certified translator must be used in the completion of informed consent for non-English speaking individuals.\n* Patients must have surgically resectable, macroscopic Stage IIIB-D cutaneous melanoma or oligometastatic resectable stage IV (M1a, M1b, and M1c) melanoma per American Joint Committee on Cancer 8th Edition Staging Criteria. Patients are eligible at the time of the initial diagnosis or recurrence after previous surgery. Patients should have \\> 1 RECIST measurable lesion.\n* Participants must have Eastern Cooperative Group (ECOG) performance status score of 0, 1 or 2 at initial screening.\n* Life expectancy of at least 12 weeks.\n* Adequate bone marrow, liver, and renal function:\n* Hemoglobin \\>8.0 g\u002FdL\n* Platelets \\>75\u002Fmm3\n* ANC \\>1.5\u002Fmm3\n* Creatinine Clearance \\> 30mL\u002Fmin\n* AST and ALT less than 3 times the Upper Limit of Normal. participants with Gilbert's syndrome are excluded if total bilirubin \\> 3.0 × ULN; or direct bilirubin \\> 1.5 × ULN\n* Total Bilirubin \\\u003C 3.1.\n* Albumin ≥ 3.0 g\u002FdL\n* Absolute neutrophil count ≥ 1.5 × 109\u002FL\n* Absolute lymphocyte count ≥ 0.5 × 109\u002FL\n* Women of childbearing potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment.\n* Females of childbearing potential and males must be willing and able to use a highly effective method of contraception to avoid pregnancy for the duration of the study and for at least 6 months after the last dose of study treatment. Acceptable means of contraception are listed in the fianlimab institutional brochure.\n* Male participants must be willing to abstain from donating sperm from the time of enrollment until 6 months after administration of study interventions.\n\nExclusion Criteria:\n\n* Participants with visceral, bone, or brain metastases.\n* Participants with a local recurrence in scar or surgical bed of the primary melanoma as the sole site of disease.\n* Participants with N1a or N2a only disease.\n* Participants with a diagnosis of acral, ocular or mucosal melanoma.\n* Participants with a history of a malignant disease that can interfere with interpretation of study results.\n* Participants with previous treatment with investigational or standard immunotherapy for melanoma or other malignancy.\n* Patients with a history of myocarditis.\n* Patients with a TnT or troponin I (TnI) \\> 2x institutional ULN at baseline. Patients with Troponin T (TnT) or troponin levels between \\> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \\> 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on the medical judgement in the patient's best interest.\n* Participants with known untreated or symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Known hypersensitivity to the active substances or to any of the excipients.\n* Participants with a known history of chronic viral infections as indicated below.\n* Known HBV infection defined as hepatitis B surface antigen reactive. NOTE: Participants with HBV infection on stable anti-viral therapy for \\> 4 weeks prior to the planned first study intervention and viral load confirmed as undetectable during Screening may be eligible.\n* Known active HCV infection defined as detectable HCV RNA (qualitative) infection. NOTE: History of HCV is not exclusionary if participant has received curative treatment and viral load is confirmed as undetectable during Screening.\n* HIV infection with CD4 count \\\u003C200\u002Fmicroliter as measured within screening time period. Patients with HIV infectious should be on combination antiretroviral medication.\n* History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.\n* Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents except for the following: . The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.\n* Participants with a history of allogeneic tissue\u002Fsolid organ transplant.\n* Live vaccine within 30 days of the planned administration of a study drug.\n* Positive pregnancy test during screening. Pregnant or lactating women are prohibited from enrolling in this study.\n* Participants must not have any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study treatment administration, impair the ability of the participant to receive protocol therapy, or interfere with the interpretation of study results.",{"count":84,"type":20},35,[86],"PHASE2","This is a phase II, open label clinical trial determining efficacy of Fianlimab in combination with Cemiplimab in subjects with Melanoma. These are subjects who will have surgery to remove their cancer.",[26],"NOT_YET_RECRUITING","2026-06-03",{"date":92,"type":35},"2026-06-05",{"date":94,"type":20},"2026-07-01",{"date":96,"type":20},"2030-02-01",{"name":98,"class":42},"University of California, Irvine",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":99},"100546867","identification-of-metabolic-phenotypes-associated-with-melanoma-metastasis-100546867","NCT06400550","Identification of Metabolic Phenotypes Associated With Melanoma Metastasis","Inclusion Criteria:\n\n* Patients with known or probable malignant melanoma lesions requiring surgical biopsy or excision.\n* Subjects of all races and ethnic origins over age 18.\n\nExclusion Criteria:\n\n* Not a surgical candidate\n* Poorly controlled diabetes",{"count":107,"type":20},400,"OBSERVATIONAL","The goal of this study is to observe metabolic features associated with human melanoma tumors.",[26],"2026-06-01",{"date":113,"type":35},"2026-06-02",{"date":115,"type":35},"2018-08-01",{"date":117,"type":20},"2028-08-01",{"name":119,"class":42},"University of Texas Southwestern Medical Center",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":99},"100493399","phase-2-phase-ii-study-of-nivolumab-in-combination-with-relatlimab-in-patients-with-active-melanoma-brain-metastases-100493399","NCT05704647","Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Life Expectancy \\> 12 weeks.\n3. Subjects must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.\n\n   • Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.\n4. Histologically confirmed malignant melanoma with measurable metastases in the brain (≥ 0.5 cm).\n5. At least one measurable intracranial target lesion, which previously was not treated with local therapy (no prior SRS to this lesion).\n\n   • Largest diameter of ≥ 0.5cm, but ≤ 3cm as determined by contrast-enhanced MRI.\n6. Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) OR at least 4 unstained slides, with an associated pathology report, for testing of tumor PD-L1 expression:\n\n   * Tumor tissue should be of good quality based on total and viable tumor content.\n   * Patients who do not have tissue specimens may undergo a biopsy during the screening period. Acceptable samples include core-needle biopsies for deep tumor tissue or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. Fine Needle Aspirations (FNA) will not be considered acceptable for tissue procurement.\n   * Tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable.\n   * However, if repeat biopsy is not feasible, and no archival tissue available patient still may be enrolled.\n7. Prior SRT and prior excision of up to 5 MBM is permitted if there has been complete recovery, with no neurologic sequelae, and measurable non irradiated lesions remain.\n8. Growth or change in a lesion previously irradiated will not be considered measurable. Regrowth in cavity of previously excised lesion will not be considered measurable.\n\n   • Any prior SRT to brain lesions or prior excision must have occurred ≥ 1 weeks before the start of dosing for this study.\n9. Radiation to NON-CNS lesions. Prior radiation to NON-CNS is allowed and does not require a washout period for treatment initiation.\n10. Subjects must be free of neurologic signs and symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroid therapy in the 5 days prior to beginning protocol therapy.\n11. ECOG performance status ≤1.\n12. Adequate organ function as described below.\n13. Women of child-bearing potential (WOCBP) must not be breastfeeding and must have a negative pregnancy test within 3 days prior to initiation of dosing. She must agree to use an acceptable method of birth control from the time of the negative pregnancy test, through the duration of treatment with the study combination plus 5 half lives of study treatment for a total of 5 months post -treatment completion. WOCBP must agree to adhere to the contraceptive guidance in Appendix 5. NOTE: A female participant is eligible to participate if she is not a woman of childbearing potential as defined Appendix 4.\n14. All associated toxicity from previous or concurrent cancer therapy must be resolved (to ≤ grade 1 or baseline) prior to study treatment administration. This excludes non-serious toxicities. However, stable endocrinopathies requiring replacement therapy will be allowed.\n15. Steroids for physiological replacement are allowed.\n\nExclusion Criteria:\n\n1. History of known leptomeningeal involvement (lumbar puncture not required).\n2. Previous stereotactic or highly conformal radiotherapy within 1 weeks before the start of dosing for this study. NOTE: The stereotactic radiotherapy field must not have included the brain index lesion(s).\n3. Subjects previously treated with SRT \\> 5 lesions in the brain. Prior whole brain radiation is not allowed.\n4. Brain lesion size \\> 3 cm.\n5. Prior checkpoint inhibitor therapy in the metastatic setting\n\n   • Patients who received ipilimumab and\u002For anti-PD1 as adjuvant or neoadjuvant therapy must have a 6-month washout before receiving any dosing on this study.\n6. 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.\n7. Subjects with major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled.\n8. Subject has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful treatment of superficial bladder cancer, in situ cervical cancer, or other in-situ cancers. Subjects with a completely treated prior malignancy and no evidence of disease for ≥ 2 years are eligible.\n\n   a. Skin Cancer Exclusion: Please note that basal cell carcinoma and squamous cell carcinoma is exempt from needing resection prior to treatment. (Resection can be completed after the start of treatment).\n9. Has a known history of or is positive for hepatitis B (hepatitis B surface antigen \\[HBsAg\\] reactive) or hepatitis C (hepatitis C virus \\[HCV\\] RNA \\[qualitative\\] is detected).\n\n   a. NOTE: Without known history, testing needs to be performed to determine eligibility. Hepatitis C antibody (Ab) testing is allowed for screening purposes in countries where HCV RNA is not part of standard of care.\n10. Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority.\n11. The use of corticosteroids is not allowed for 10 days prior to initiation of therapy (based upon 5 times the expected half-life of dexamethasone) except patients who are taking steroids for physiological replacement. If alternative corticosteroid therapy has been used, consultation with the PI is required to determine the washout period prior to initiating study treatment.\n12. Subjects with a condition requiring systemic treatment with either corticosteroids (≤ 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study initiation. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n13. Major surgical procedure, open biopsy (excluding skin cancer resection), or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed) or anticipation of the need for major surgery during the study.\n14. Non-healing wound, ulcer, or bone fracture.\n15. Women who are breast-feeding or pregnant.\n16. Uncontrolled intercurrent illness (i.e., active infection ≥ grade 2) or concurrent condition that, in the opinion of the Investigator, would interfere with the study endpoints or the subject's ability to participate.\n17. History of clinically significant cardiac disease or congestive heart failure \\> New York Heart Association (NYHA) class 2. Subjects must not have unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months or a history of myocarditis.\n18. Troponin T (TnT) or I (TnI) \\> 2 × institutional ULN. 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 \\\u003C 2 × ULN, the participant may undergo a cardiac consultation and be considered for treatment, following cardiologist recommendation. Notification of the decision to enroll the participant following cardiologist recommendation has to be made to the principal investigator.\n19. Investigational drug use within 14 days (or 5 half-lives, whichever is longer) of the first dose of nivolumab and relatlimab.\n20. With a history of non-infectious pneumonitis that required steroids or current pneumonitis.",{"count":127,"type":20},30,[86],"To learn if giving nivolumab in combination with relatlimab can help to control melanoma that has spread to the brain (melanoma with brain metastases). The safety and side effects of the study drug combination will also be studied.",[26],"2026-05-13",{"date":133,"type":35},"2026-05-15",{"date":135,"type":35},"2023-02-23",{"date":137,"type":20},"2028-07-31",{"name":139,"class":42},"M.D. Anderson Cancer Center",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":170},"100477109","phase-1-start-safety-and-anti-tumor-activity-of-pepticrad-1-in-treatment-of-cancer-100477109","NCT05492682","START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer","A Study to Evaluate the Safety and Immune Activity of PeptiCRAd-1 in Combination With Pembrolizumab in Patients With Injectable Solid Tumors in Indications Known to Express NY-ESO-1 and MAGE-A3","Inclusion Criteria:\n\n1. Written informed consent.\n2. Male or female, ≥18 years of age.\n3. Patients with any 1 of the following histologically confirmed tumors and who qualifies for new or continued CPI therapy and relapsing to\u002Fafter standard therapy or the patient has refused or does not tolerate standard therapy:\n\n   * Inoperable\u002Fmetastatic cutaneous malignant melanoma\n   * Relapsed or newly diagnosed locally advanced inoperable\u002Fmetastatic TNBC\n   * Inoperable advanced\u002Fmetastatic non-squamous NSCLC\n   * Inoperable and\u002For advanced Synovial or myxoid round cell sarcoma\n   * Inoperable and\u002For advanced osteosarcoma\n   * Inoperable and\u002For advanced colorectal cancer, patients assessed as positive for NY-ESO-1 or MAGE-A3 expression at baseline\n   * Inoperable and\u002For advanced\u002Fmetastatic sarcoma, patients assessed as positive for NY-ESO-1 or MAGE-A3 expression at baseline\n4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n5. Tumor lesion which is deemed feasible for biopsy and injection\n6. ECOG\u002FWHO performance status 0 to 1.\n7. Acceptable liver and renal function, defined as:\n\n   * Total bilirubin ≤1.5 x upper limit of normal (ULN; does not include patients with Gilbert's Disease), and\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x ULN, and\n   * Serum creatinine ≤1.5 x ULN\n8. Acceptable hematological function, defined as:\n\n   * Hemoglobin ≥9 g\u002FdL, and\n   * Neutrophils ≥1.5 x 109\u002FL, and\n   * Platelet count ≥100 x 109\u002FL Patients may be transfused to meet the hemoglobin entry criteria.\n9. Acceptable coagulation status defined by international normalized ratio (INR) of blood clotting, prothrombin time and activated partial thromboplastin time within ≤1.5 x upper limit of normal.\n10. Negative pregnancy test at screening in all women of childbearing potential (WOCBP). Such patients must agree to use a highly effective method of contraception (Appendix 1) during study intervention and for 3 months after the last virus treatment, 4 months after the last dose of pembrolizumab, and 12 months after CPO dosing. Male patients and male partners of female patients must also use barrier contraception, i.e., condom, for the time periods specified for WOCBP, plus a further 3 month period.\n\n    Urine pregnancy tests should have a sensitivity of at least 25 mIU\u002FmL for human chorionic gonadotropin (hCG). If the urine test is positive, it must be followed by a quantitative analysis of hCG concentration in blood.\n11. Prior therapy with an immune CPI is allowed provided a 6-week washout period is observed for patients with prior programmed cell death (PD)1 or PDL1 treatment\n\nExclusion Criteria:\n\n1. Receipt of any oncolytic virus treatment, or administration of a vaccine containing live virus within 4 weeks before Day 1.\n2. Use of significant immunosuppressive medication, including high dose corticosteroid (defined as the equivalent of \\>10 mg\u002Fday prednisone) within 4 weeks before Day 1. Inhaled or topical corticosteroid use is allowed.\n3. Prior or concomitant radiotherapy within 4 weeks before Day 1.\n4. Participation in a study with an investigational drug or device within 4 weeks prior to Day 1.\n5. Active bacterial, viral, or fungal infection that requires systemic therapy.\n6. Active autoimmune disease that has required systemic treatment in the past two years.\n7. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient, if included in this study.\n8. Any concomitant medical condition requiring receipt of a therapeutic anticoagulant that, in the opinion of the treating physician, cannot safely be withheld to allow for repeated injection of PeptiCRAd 1 and tumor biopsies.\n9. Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C or active tuberculosis.\n10. Known active central nervous system metastases. Patients with leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiographic signs of CNS hemorrhage are excluded.\n\n    Note: Participants with asymptomatic brain metastases (i.e. off corticosteroids and anticonvulsants for at least 7 days) are permitted.\n11. Any prior severe AE according to Common Terminology Criteria for Adverse Events (CTCAE), severe hypersensitivity reaction attributed to prior anti-PD1 or PDL1 therapy or components of the study intervention or has a history of any contraindication that, in the investigator's opinion, would contraindicate pembrolizumab administration such as:\n\n    * Resolution of side effect of prior anti-PD1 or PDL1 therapy to Grade 1\n    * Grade 2 or higher pneumonitis\n    * Grade 4 AST or ALT elevation\n    * Grade 3 or higher colitis attributable to immunotherapy Note: in the absence of clinical symptoms of pancreatitis, elevations of amylase or lipase are not contraindications to therapy on this trial.\n12. History of or planned tissue \u002F organ transplant.\n13. Females who are pregnant or breast feeding or expecting to conceive within the projected duration of the study starting with the screening visit or males expecting to father children within the projected duration of the study starting with the screening visit.\n14. Unwillingness or inability to comply with the study protocol for any reason.\n15. Admission to an institution by virtue of an order issued by the judicial or administrative authorities.\n16. Sponsor or Contract Research Organization employees, or employees under the direct supervision of the investigator or the investigational sites and\u002For involved directly in the study.\n17. Prior or concurrent malignancy, unless the natural history or treatment of the disease does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.",{"count":148,"type":20},15,[150],"PHASE1","This study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy.",[26,153,154,155,156,157,158,159],"Triple-Negative Breast Cancer","Non-Small Cell Lung Cancer","Synovial Sarcoma","Myxoid Liposarcoma","Colorectal Cancer","Osteosarcoma","Sarcoma","2026-05-11",{"date":162,"type":35},"2026-05-12",{"date":164,"type":35},"2023-02-02",{"date":166,"type":20},"2027-05-31",{"name":168,"class":169},"Valo Therapeutics Oy","INDUSTRY",7,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":99},"100575381","phase-2-metronomic-cyclophosphamide-with-pembrolizumab-in-checkpoint-inhibitor-refractory-melanoma-100575381","NCT06771544","Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma","Inclusion Criteria:\n\n* Age ≥18 years at the time of signing informed consent form (ICF)\n* Patients must have unresectable Stage III or Stage IV non-ocular melanoma per American Joint Committee on Cancer 8th Edition Staging Criteria not amenable to local therapy\n* Participants must have measurable disease by RECIST v1.1 criteria as assessed by investigator\u002F radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n* Participants must have Eastern Cooperative Group (ECOG) performance status score of 0, 1 or 2 at screening visit.\n* Life expectancy of at least 12 weeks\n* Adequate bone marrow, liver, and renal function\n* Hemoglobin ≥9.0 g\u002FdL\n* Platelets ≥100\u002Fmm3\n* ANC ≥1.5\u002Fmm3\n* Creatinine Clearance ≥ 30mL\u002Fmin Cockcroft-Gault CrCl, mL\u002Fmin = (140 - age) × (weight, kg) × (0.85 if female) \u002F (72 × Cr, mg\u002FdL).\n* AST and ALT less than 3 times the Upper Limit of Normal or less than 5 times the Upper Limit of normal with liver metastases. T Bilirubin \\\u003C 3.1 mg\u002FdL.\n* Has progressed on a prior PD-1\u002FPD-L1 treatment\n* Recovered from toxicities of pembrolizumab to Grade ≤1, excluding endocrine toxicities\n* Prior Receipt of PD-1\u002FPD-L1 therapy within 9 weeks prior to the first dose of the investigational therapy.\n* Women of childbearing potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment\n* Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study.\n* Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the trial screening date until 3 months after the final dose of study intervention; cessation of birth control after this point shall be discussed with a responsible physician.\n* Pregnant or lactating women are prohibited from enrolling in this study.\n* Male participants are not allowed to donate sperm from the time of enrollment until 6 months after administration of study interventions.\n\nExclusion Criteria:\n\n* Participants with a diagnosis of ocular or metastatic uveal melanoma\n* Participants with a history of a malignant disease other than those being treated in this study. The following exceptions are permitted:\n* Malignancies that were treated curatively and have not recurred within 2 years. Shorter intervals can be considered after discussion with the Principal Investigator.\n* Completely resected basal cell and squamous cell skin cancers.\n* Any malignancy considered to be indolent and that has never required therapy, such as chronic lymphocytic leukemia.\n* Completely resected carcinoma in situ of any type\n* Participants ineligible to be retreated with pembrolizumab due to a treatment-related AE while on a prior anti-PD(L)-1 regimen that led to discontinuation of that prior therapy and would thus prevent retreatment or with an immune-related adverse event (irAE) of grade 3 or greater\n* Participants with known untreated or symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis. NOTE: Participants with previously treated brain metastases may participate provided ALL of the following apply:\n* Treated CNS lesions are radiographically stable (without evidence of progression for ≥ 28 days prior to the first dose of study intervention) after intervention (eg, surgery and\u002For radiation).\n* Neurologically stable and on stable dose of ≤ 10mg of prednisone equivalent steroids for at least 7 days prior to the first dose of study intervention.\n* Any prior investigational or standard cancer therapy, with exception of PD-1\u002FPD-L1 (includes nivolumab + Relatlimab) therapy, chemotherapy or radiation within 6-9 weeks of the first dose of the investigational therapy (see Inclusion Criteria)\n* Presence of B-RAF driver mutation without prior receipt of BRAF +\u002F- MEK inhibitors, unless patient declines BRAF +\u002F-MEK inhibition for any reason or is unable to tolerate BRAF and\u002For MEK inhibitors.\n* Participants with a known history of chronic viral infections as indicated below. If patients do not have a known history, testing is not required during the screening period to confirm the patient has an active infection.\n* Known HBV infection defined as hepatitis B surface antigen reactive. NOTE: Participants with HBV infection on stable anti-viral therapy for \\> 4 weeks prior to the planned first study intervention and viral load confirmed as undetectable during Screening may be eligible.\n* Known active HCV infection defined as detectable HCV RNA (qualitative) infection. NOTE: History of HCV is not exclusionary if participant has received curative treatment and viral load is confirmed as undetectable during Screening.\n* Active HIV infection. Those with HIV infections on combination antiretroviral medications with stable CD4 count \\>200\u002Fmicroliters as measured within screening time period. If the patient does not have a known history of HIV, then testing is not required during screening to confirm presence or absence of HIV.\n* Positive serum pregnancy test\n* Participants with out-of-range screening laboratory values as defined below. NOTE: Hematology evaluations must be performed \\>7 days from any blood transfusion. Or blood product transfusion or from any dose of hematologic growth factor.\n* Glomerular filtration rate (calculated using the Chronic Kidney Disease Epidemiology Collaboration formula) \\\u003C 30 mL\u002Fmin\n* Total bilirubin \\> 1.5 × ULN; participants with Gilbert's syndrome are excluded if total bilirubin \\> 3.0 × ULN; or direct bilirubin \\> 1.5 × ULN\n* Albumin \\\u003C 3.0 g\u002FdL\n* Absolute lymphocyte count \\\u003C 0.5 × 10\\^9\u002FL\n* Participants with a history of allogeneic tissue\u002Fsolid organ transplant",{"count":178,"type":20},14,[86],"This is a phase 2, single-arm, open label clinical trial determining efficacy of Cyclophosphamide and Pembrolizumab in subjects with melanoma.",[30,182,26,183],"Melanoma Stage III","Melanoma Stage IV",[30,185,186,187,188,189],"Melanoma, Stage III","Skin","Melanoma, Stage IV","Pembrolizumab","Cyclophosphamide","2026-03-06",{"date":192,"type":35},"2026-03-10",{"date":194,"type":35},"2024-12-23",{"date":196,"type":20},"2028-12",{"name":98,"class":42},{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":21,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":170},"100589613","phase-1-a-phase-12-clinical-trial-to-assess-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-hmbd-501-in-patients-with-her3-expressing-solid-tumors-100589613","NCT06956690","A Phase 1\u002F2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With HER3-Expressing Solid Tumors","A First-in-Human, Open-label, Phase 1\u002F2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With Advanced-Stage, Relapsed\u002FRefractory HER3-Expressing Solid Tumors","Inclusion Criteria:\n\n* Body weight ≥ 40 kg.\n* Willing and able to provide signed written informed consent before any study-related screening procedures are performed.\n* Patients with histologically or cytologically confirmed diagnosis of advanced-stage or metastatic HER3+ solid tumors that are relapsed or refractory to or ineligible for standard therapy, or for whom no standard therapy is available; or the patient has documented their refusal of standard of care therapies. These include the following:\n\n  1. Unresectable or metastatic cutaneous melanoma (HER3+)\n  2. Locally advanced or metastatic mutated EGFR (mEGFR) NSCLC (HER3+)\n  3. Unresectable, locally advanced or metastatic breast cancer\n  4. Relapsed or refractory solid tumors, with documented HER3+ expression such as Pancreatic Ductal Adenocarcinoma (PDAC) and gastric cancers, may be allowed in the protocol following sponsor approval on a case-by -case basis.\n* If molecular pathology report to confirm HER3+ status is not available, willingness to undergo fresh tumor biopsy for retrospective assessment of HER3+ status following enrollment..\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.\n* Contraceptive requirements:\n\n  1. Women of childbearing potential (WOCBP) must use contraception from at least 28 days prior to study start, during the study, and for at least 6 months after the last dose of study drug.\n  2. Males who are sexually active with partner(s) who are WOCBP must agree to use a male condom with spermicide beginning at study start, during the study and for at least 6 months after the last dose of study drug.\n* Females must:\n\n  1. Agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 6 months after the last dose of study drug.\n  2. Agree to not breastfeed and do not plan to become pregnant during the study and for at least 6 months after the last dose of study drug.\n* Males must:\n\n  1. Agree to not donate sperm beginning at study start, during the study, and for at least 6 months after the last dose of study drug.\n  2. Agree to not plan to father a child beginning at study start, during the study, and for at least 6 months after last dose of study drug.\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Any of the following treatment interventions within the specified time frame prior to study drug administration at study start:\n\n  1. Any anti-tumor-directed drug therapy within 21 days or 5 times the elimination half-life (whichever is shorter).\n  2. Treatment with investigational drugs within 21 days.\n  3. Major surgery within 21 days.\n  4. Radiation therapy ≤4 weeks or radiotherapy that included \\>30% of the bone marrow.\n  5. Autologous or allogeneic stem cell transplantation or allogeneic tissue\u002Forgan transplant within 3 months.\n  6. CYP3A4 strong inhibitor (including any prescription or non-prescription drugs or herbal supplements) ≤4 half-lives.\n  7. CYP3A4 strong inducer ≤4 half-lives.\n  8. OATP1B inhibitor (including any prescription or non-prescription drugs or herbal supplements) ≤4 half-lives.\n* Prior treatment with a HER3-targeted ADC or any exatecan- or exatecan-derivative-conjugated ADC inhibitor as last line of therapy.\n* Prior treatment with a topoisomerase I inhibitor as last line of therapy.\n* Primary immune deficiency (e.g. congenital syndromes).\n* Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment within 2 weeks prior to study start.\n* Known\u002Fsuspected hypersensitivity against ENV-501, human or humanized immunoglobulin Gs (IgGs), or their ingredients.\n* History of noninfectious or drug-induced pneumonitis or interstitial lung disease (ILD).\n* Known seropositivity (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).\n* Leptomeningeal disease, symptomatic or uncontrolled (active) brain metastasis (note: brain metastases not requiring steroids or anti-epileptic therapy are allowed if stable for ≥4 weeks prior to study start and patient is neurologically stable).\n* Pregnant or WOCBP who have a positive b-human chorionic gonadotropin (HCG) test result at Screening or within 7 days prior to study start.\n* Patients with second malignancies that are active (uncontrolled, metastatic) or requiring therapy.\n* Patient who is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study site or the Sponsor.",{"count":206,"type":20},180,[150,86],"This study is a Phase 1\u002F2, first-in-human, open-label, clinical trial to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of HMBD-501 in patients with advanced-stage, relapsed and\u002For refractory human epidermal growth factor receptor 3 (HER3)-expressing solid tumors. The study consists of 2 phases: a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2).\n\nThe primary objectives of Phase 1 are to characterize the overall safety and tolerability profile of increasing doses of HMBD-501 in patients with advanced-stage solid tumors and identify the recommended Phase 2 dose (RP2D) of ENV-501. During Phase 1, successive cohorts of patients will receive escalating doses of HMBD-501. The results of the dose escalation will determine the RP2D and dosing schedule of HMBD-501 to be administered in the Phase 2 part of the study. The primary objective of Phase 2 is to evaluate the preliminary clinical efficacy of HMBD-501 in dose expansion cohorts.",[26,210,211],"Non Small Cell Lung Cancer","Breast Cancer","2026-02-26",{"date":214,"type":35},"2026-03-02",{"date":216,"type":35},"2025-12-17",{"date":218,"type":20},"2027-07",{"name":220,"class":169},"Hummingbird Bioscience",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":21,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":99},"100462869","study-of-alterations-in-tumor-metabolism-associated-with-the-development-of-immunotherapy-resistance-in-melanoma-100462869","NCT05307289","Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma","MEL-META","Inclusion Criteria:\n\n* Female or male, 18 years of age or older\n* Stage III unresectable or histologically confirmed stage IV cutaneous melanoma (melanoma of unknown origin is accepted), treatment naïve (metastatic stage) and for which immunotherapy will be started\n* Performance Status ≤1\n* BRAF status available; BRAF status determination is required but patient will be eligible regardless of BRAF status\n* For women of childbearing potential, effective contraception must be initiated during the study.\n* Patient affiliated to social security plan\n* Patient having signed informed consent\n\nExclusion Criteria:\n\n* Breastfeeding or pregnant patients: for women of childbearing age, a urine pregnancy test will be performed\n* Patients with ocular or mucosal melanoma of metastatic ocular melanoma\n* Patients with metastatic melanoma not treated with immunotherapy (i.e. treated with a combination of targeted therapies).\n* Contraindication to the initiation of immunotherapy: HIV and\u002For HCV and\u002For HBV positive, active autoimmune disease (chronic inflammatory bowel disease such as ulcerative colitis, Crohn's disease, vasculitis, etc.), patients with autoimmune motor neuropathy (such as Guillain Barré syndrome).\n* Vulnerable patients: minors, adults under guardianship or curatorship, deprived of liberty\n* Vulnerable persons (minors, patients under guardianship or curatorship, deprived of liberty, under court protection, etc.).\n* A psychiatric or addiction history that will compromise the patient's ability to consent and follow the proper protocol procedures\n* Any other clinical finding that, in the opinion of the principal investigator, could interfere with the results of the study or pose a risk to the patient during the study.",{"count":229,"type":20},20,[23],"Among the mechanisms responsible for resistance to immunotherapy, metabolism seems to play a major role. A better understanding of tumor metabolism appears to be absolutely necessary in order to propose efficient therapeutic alternatives to target tumor cells without exerting a deleterious effect on the cells responsible for the anti-tumor immune response. The main objective is to evaluate metabolism modulations in melanoma cells extracted from metastases of patients sensitive and resistant to immunotherapies (anti-PD1 or anti-PD1+anti-CTLA4).",[26],"2025-12-24",{"date":235,"type":35},"2025-12-31",{"date":237,"type":35},"2022-05-25",{"date":239,"type":20},"2028-10-25",{"name":241,"class":42},"Centre Hospitalier Universitaire de Nice",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":250,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":21,"phases":253,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":99},"100574101","omitting-therapeutic-lymph-node-dissection-in-patients-with-melanoma-stage-3-and-major-pathological-response-in-the-index-lymph-node-100574101","NCT06754904","Omitting Therapeutic Lymph Node Dissection in Patients With Melanoma (Stage 3) and Major Pathological Response in the Index Lymph Node","OMIT Trial: Omitting Therapeutic Lymph Node Dissection in Patients With Stage IIIB\u002FC Melanoma and Major Pathological Response in the Index Lymph Node After Neoadjudvant Immunotherapy","OMIT","Inclusion Criteria:\n\n* Patients must be eligible for neoadjuvant treatment (ipilimumab and nivolumab)\n* Patients must be 16 years of age or older.\n* Patients must have a histologically confirmed diagnosis of macroscopic resectable stage III melanoma (stage III B\u002FC\u002FD) with one or more macroscopic lymph node metastase defined as either one:\n* a palpable node, confirmed as melanoma by pathology; a non-palpable but enlarged lymph node according to RECISTv1.1 (at least 15 mm in short axis), confirmed as melanoma by pathology;\n* a PET scan positive lymph node of any size confirmed as melanoma by pathology;\n* The patient must have a measurable tumor burden that qualifies (according to clinical practice) for neoadjuvant therapy with immune checkpoint inhibitors\n* Patients in whom ILN marking is feasible\n* Written informed consent\n\nExclusion Criteria:\n\n* Uveal\u002Focular or mucosal melanoma\n* WHO performance status of two or more\n* In-transit metastases only (without cytological or histological proven lymph node involvement)\n* Prior targeted therapy targeting BRAF and\u002For MEK for melanoma\n* Prior immunotherapy targeting CTLA-4, PD-1 or PD-L1 for melanoma\n* Patients with (history of) distant metastasis (stage IV melanoma)","16 Years",{"count":252,"type":20},213,[23],"Rationale: The randomized trial NADINA has demonstrated that neoadjuvant treatment with nivolumab with ipilimumab improves event-free survival (EFS) in patients with macroscopic resectable stage III melanoma. In this study, therapeutic lymph node dissection (TLND) was standard of care, showing that patients achieving a major pathological response (MPR, i.e., ≤10% residual viable tumor bed) have an excellent outcome (EFS and Distant Metastasis Free Survival (DMFS)). The PRADO trial indicated that the MPR definition can also be revealed from a surrogate lymph node response, the index lymph node (ILN), allowing sparing the extensive surgery in MPR patients. In these MPR patients the DMFS was 100% after 1 year and 98% after 2 years, and recurrence-free survival (RFS) was 95% after 1 year and 93% after 2 years. Given that TLND is associated with morbidity and has a significant impact on health-related quality of life (HR-QoL) and healthcare costs, this study aims to prospectively investigate the safety of omitting TLND in patients who have an MPR within the ILN after neoadjuvant immunotherapy.\n\nObjectives: To investigate whether TLND can be safely omitted in patients with macroscopic resectable stage III (B\u002FC\u002FD) melanoma achieving an MPR within the ILN upon neoadjuvant treatment with immune checkpoint inhibitors (ipilimumab and nivolumab).\n\nStudy design: This study is a prospective, single-arm phase 2 nationwide multicenter trial.\n\nStudy population:\n\nInclusion criteria for study participants are as follows:\n\n* Patients must be eligible for neoadjuvant treatment\n* Patients must have a histologically confirmed diagnosis of macroscopic resectable stage III melanoma (stage III B\u002FC\u002FD) with one or more macroscopic lymph node metastasis\n* The patient must have a measurable tumor burden that qualifies (according to clinical practice) for neoadjuvant therapy\n\nIntervention: Omitting TLND in patients who achieve an MPR in the ILN following neoadjuvant ipilimumab and nivolumab.\n\nMain study endpoints: The two coprimary endpoints are 2-year Local Recurrence Free Survival (LRFS) and 2-year DMFS.",[256],"Melanoma, Skin",[258,259,260,261,262,263,264],"Neoadjuvant","Ipilimumab","Nivolumab","Immunotherapy","Index node","Therapeutic lymph node dissection","Omitting","2025-08-04",{"date":267,"type":35},"2025-08-07",{"date":269,"type":35},"2025-04-23",{"date":271,"type":20},"2032-04-01",{"name":273,"class":42},"D.J. (Dirk) Grünhagen",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":284,"conditions":285,"keywords":286,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":99},"100309984","french-clinical-datbase-of-melanoma-patients-ric-mel-100309984","NCT03315468","French Clinical Datbase of Melanoma Patients (RIC-Mel)","French National Cohort of Patients With Melanoma (Any Stage). Network for Research and Clinical Investigation, the RIC-Mel Network.","RIC-Mel","Inclusion Criteria:\n\n* Patient with melanoma, of any stage,\n* Patient agreed to participate.\n\nExclusion Criteria:\n\n* Individuals under court protection",{"count":283,"type":20},16000,"With a high incidence, low survival rates and limiter availability of effective treatment, melanoma is one of the research priorities for health authorities. Optimizing the development of both academic and private research requires the availability information on the features of patients.\n\nTo meet this need, the French Multidisciplinary Melanoma Group (GMFMel) in collaboration with INCa (French National Cancer Institute), the CeNGEPS (National Centre for Healthcare Products Trial Management) and the CIC-BT0503 from Nantes University Hospital (Biotherapy Clinical Centre of Investigation) has set up in April 2011 a Clinical Investigation Network for melanoma, called the CeNGEPS-GMFMel network. Nowadays, the network is named :\n\nRIC-Mel : network for Research and Clinical Investigation on Melanoma. Aims of the network are to promote translational and epidemiological projects as well as to optimize the achievements of clinical trials.\n\nTo achieve these goals, a database was launched in 2012 that gives a permanently updates mapping of melanoma treated in France with the key information needed for any research projects.",[26],[287,288,289],"melanoma","database","cohort","2025-07-17",{"date":292,"type":35},"2025-07-22",{"date":294,"type":35},"2012-03-01",{"date":296,"type":20},"2030-03-01",{"name":298,"class":42},"Nantes University Hospital",{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":21,"phases":308,"briefSummary":309,"conditions":310,"keywords":314,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":327},"100565523","evaluation-of-a-personalised-survivorship-care-plan-app-for-patients-with-melanoma-100565523","NCT06643286","Evaluation of a Personalised Survivorship Care Plan App for Patients With Melanoma","Personalised Survivorship Care for Patients With Melanoma: A Multicenter Randomised Controlled Trial of the Survivorship Care Plan App","Melanoma SCP","Inclusion Criteria:\n\n* 18 years or older\n* Patients who have received a primary diagnosis of cutaneous melanoma stage I to II in the past 0-4 months\n\nExclusion Criteria:\n\n* Patients with irresectable stage III melanoma, patients receiving neo-adjuvant treatment and patients with stage IV melanoma.\n* Patients who do not have (sufficient) command of the Dutch language.",{"count":206,"type":20},[23],"A multicentre randomised controlled trial (RCT) will be conducted to evaluate the effectiveness of the digital personalised Melanoma Survivorship Care Plan (SCP) app. A total of hundred-eighty melanoma patients (stage I and II) will be randomised to receive either the SCP Melanoma app or usual care. The app provides survivors with personalized healthcare information on diagnosis, treatment and follow-up and supportive care, tailored to their melanoma stage and phase and information needs.Through questionnaires, medical file records, patient-reported outcomes and use of medical care will be evaluated. In addition, log-data, questionnaires and interviews will be used to evaluate the process of the uptake and implementation of the digital SCP.",[26,311,312,313],"Melanoma, Stage II, Stage I","Melanoma Stage","Survivorship",[315,316,317],"Survivorship care","Application","RCT","2025-06-06",{"date":320,"type":35},"2025-06-11",{"date":322,"type":35},"2025-04-01",{"date":324,"type":20},"2026-12-01",{"name":326,"class":42},"Erasmus Medical Center",4,{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":337,"conditions":338,"keywords":339,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":99},"100575646","real-life-pharmacological-monitoring-of-encorafenib-binimetinib-in-the-treatment-of-metastatic-melanoma-100575646","NCT06774989","Real-life Pharmacological Monitoring of Encorafenib-Binimetinib in the Treatment of Metastatic Melanoma","SPEBINI","Inclusion Criteria:\n\nAdults ≥ 18 years of age\n\n* Histologically confirmed advanced melanoma, stage III\u002Fstage IV inoperable (primary cutaneous, mucosal or unknown)\n* Treatment with encorafenib and\u002For binimetinib, whatever the line of treatment, for curative purposes.\n* Affiliated to a social security scheme or beneficiary of such a scheme\n* informed and non-opposition collected.\n\nExclusion Criteria:\n\n\\-",{"count":336,"type":20},66,"In recent years, the prognosis for BRAFV600E-mutant metastatic melanoma has been transformed with targeted therapies combining BRAF and MEK inhibitors (dabrafenib-trametinib and encorafenib-cobimetinib), which have improved progression-free survival and overall survival. However, adverse events are very frequent, and a significant proportion of patients progress secondarily. Several clinical studies have shown that inter-individual variability in plasma exposure to BRAF inhibitors (dabrafenib, vemurafenib) or MEK inhibitors (trametinib) may contribute in part to the occurrence of severe toxicities, and on the efficiency of the treatment. To our knowledge, no data are currently available on the exposure\u002Ftoxicity relationship for encorafenib and binimetinib.\n\nThe aim of this study is to assess the association between plasma exposure of encorafenib and binimetinib and the occurrence of dose-limiting toxicity during the first 3 months of treatment.\n\nOur secondary objectives are the identification of factors of variability in plasma exposure to encorafenib and binimetinib, the assessment of the exposure-response relationship to treatment (PFS, OS), the evaluation of the influence of the residual plasma concentration of checkpoint inhibiting antibodies (nivolumab, pembrolizumab, ipilimumab) in the first month on the occurrence of dose-limiting toxicity during treatment with encorafenib\u002Fbinimetinib. Also, the investigators will study the relationship between the kinetics of circulating tumour DNA levels and plasma exposure to encorafenib and binimetinib. Finally, the investigators will assess compliance with treatment.\n\nAll patients over the age of 18 receiving encorafenib-binimetib for BRAF-mutated metastatic or locally advanced non-operable melanoma, regardless of line, in our 5 centres, will be included.\n\nAfter the patient has been informed and informed that he or she does not wish to be included in the study, an additional blood test will be taken during follow-up visits to the HDJ or specific follow-up consultation for his or her metastatic melanoma, where blood sampling is already planned as part of the treatment, during 1 year.\n\nThe tubes will be sent to the laboratories for analysis in the usual way as part of routine care. A self-questionnaire will be given to the patient at different follow-up visits.\n\nResearch data, including clinical, biological and self-questionnaire data, will be collected in the study via a web interface (e-CRF).\n\nFollow-up of the population will follow the rhythm of visits scheduled as part of the usual care of patients with melanoma undergoing targeted therapy. the investigators plan a 1-year sampling period, and a 2-year clinical follow-up period for each patient from the time of inclusion. Finally, the investigators plan a period of 1 year to analyze the data and write the article.\n\nStatistical analysis will be carried out by the investigating team (R software).",[26],[287,340,341,342],"targeted therapy","BRAF and MEK inhibitors","pharmacokinetics","2025-03-17",{"date":345,"type":35},"2025-03-18",{"date":347,"type":35},"2025-01-02",{"date":349,"type":20},"2028-01",{"name":351,"class":42},"Assistance Publique - Hôpitaux de Paris",{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":362,"conditions":363,"keywords":367,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":377,"locationsCount":379},"100576398","observational-study-of-patients-with-advanced-melanoma-skin-cancer-to-assess-if-iopener-melanoma-test-can-predict-response-to-immunotherapy-100576398","NCT06784778","Observational Study of Patients With Advanced Melanoma (Skin Cancer) to Assess if IOpener®-Melanoma Test Can Predict Response to Immunotherapy.","A Prospective, Observational, Multicenter Clinical Performance Study to Evaluate IOpener®-Melanoma Test for Predicting Response to Combination or Mono Immunotherapy in Stage III or IV Cutaneous Melanoma Patients.","COMO","Inclusion Criteria:\n\n* First line treatment for unresectable stage III or IV cutaneous melanoma (according to AJCC version 8) with anti-PD1 monotherapy (nivolumab or pembrolizumab) or anti-PD1 + anti-CTL4A combination therapy (nivolumab and ipilimumab).\n* Anticipated life expectancy exceeding 3 months.\n* Aged 18 years or older and able to provide written informed consent.\n\nPatients who have completed adjuvant treatment with anti-PD1 immunotherapy at least 6 months ago can be included.\n\nExclusion Criteria:\n\n* Prior treatment for irresectable stage III or stage IV melanoma with BRAF\u002FMEK inhibitors.\n* Presence of progressive\u002Fsymptomatic brain metastases at baseline.\n* WHO performance score ≥ 2.\n* Adjuvant treatment with anti-PD1 immunotherapy received within the last 6 months.\n* Patients undergoing experimental treatments or therapies.\n* Presence of any medical or other condition that in the opinion of the investigator(s) would preclude the participation in a clinical study.\n* Unwillingness or inability to comply with study and follow-up procedures.",{"count":361,"type":20},196,"The goal of this observational study is to assess whether the IOpener® melanoma test can assist treating physicians in deciding which therapy is most suitable for patients with skin cancer (advanced cutaneous melanoma). For this purpose it is evaluated how well the IOpener-melanoma test can predict the result of cancer treatment in the treatment groups (standard of care anti-PD1 mono-therapy and standard of care anti-PD1 + anti-CTLA-4 therapy).\n\nParticipants will be asked to provide blood sample for analysis using IOpener®-melanoma test. Patients will receive regular medical care, the test results will not be used to make any treatment decisions. The patients will visit the clinic for treatment administration and clinical evaluation as part of their regular medical care.",[364,256,365,366],"Melanoma Metastatic","Melanoma Stage III or IV","Melanoma Advanced",[287,368,369,370],"IOpener","immunotherapy","immune checkpoint inhibitor","2025-02-25",{"date":373,"type":35},"2025-02-28",{"date":375,"type":35},"2024-07-12",{"date":218,"type":20},{"name":378,"class":169},"Pamgene International B.V.",3,{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":390,"conditions":391,"keywords":394,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":43},"100562611","understanding-the-transition-from-normal-melanocytes-to-nevus-to-melanoma-100562611","NCT06605417","Understanding the Transition from Normal Melanocytes to Nevus to Melanoma","Understanding the Transition from Normal Melanocytes to Nevus to Melanoma (NevustoMel)","NevustoMel","Inclusion criteria:\n\n* Congenital nevus with estimated size of 20 cm\n* Be over 18 years of age\n\nExclusion criteria:\n\n* No available biological material\n* Not having signed the informed consent",{"count":389,"type":20},100,"The primary objective of this study is to identify the molecular identity profiles of all cellular states that characterize the progression from benign nevi to malignant melanoma in CAYA patients with L\u002FGCMN. The secondary objectives are:\n\n* To longitudinally characterize the cell-free DNA (cfDNA) from CAYA patients.\n* To improve the early diagnosis and treatments for intermediate conditions such as L\u002FGCMN through evidence-based interpretation of personal risk from endogenous or exogenous sources.\n* To test pre-clinical strategies to best model and improve patient response.",[392,256,393],"Congenital Melanocytic Nevi","Nevi and Melanomas",[395,30,396,397,398,399,400,401],"Congenital melanocytic nevi","Liquid biopsy","cfDNA","Methylomics","L\u002FGCMN","RNAseq","Molecular profiles",{"date":403,"type":35},"2025-02-27",{"date":405,"type":35},"2024-01-01",{"date":407,"type":20},"2026-11-30",{"name":409,"class":42},"Fundacion Clinic per a la Recerca Biomédica",{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":418,"conditions":419,"keywords":428,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":99},"100342582","genomic-investigation-of-unusual-responders-100342582","NCT03740503","Genomic Investigation of Unusual Responders","GENIUS","Inclusion Criteria:\n\n1. The patient must have either an exceptionally good or poor response to treatment, as indicated by their treating physician.\n\n   1. The exact definition of this is adaptable to the disease but a suggested guideline is a Complete Response, Partial Response or progression free interval of at least 6 months\n   2. Exceptionally poor response includes patients who were expected to respond favourably to a treatment but instead responded poorly (e.g dramatic tumor growth or death)\n2. The patient must have sufficient archival tumor available for sequencing.\n3. Deceased patients will also be considered for analysis (up to 30 patients per year) if they meet at least one of the following requirements:\n\n   a)) Patients who have archival tissue stored within the UHN Laboratory Medicine Program who have had a consent waiver granted by the REB to access the tissue.\n\n   b) Patients who have archival tissue banked for further research within the UHN Biospecimen Sciences Program\n\n   Exclusion Criteria:\n   * None",{"count":389,"type":20},"Studies have shown that tumors from the same patient may respond very differently to the same therapeutic agents. This study aims to investigate the genetic basis of tumors that respond abnormally well or poorly to therapeutic agents in an effort to understand the fundamental genetic basis of this response. The present protocol seeks to retrospectively perform Exome, next-generation (DNA) sequencing and\u002For other molecular techniques on tumor samples to identify the genetic basis of a patient's exceptional response to chemotherapy.",[420,211,421,157,422,423,424,425,26,426,427],"Cancer","Non-small Cell Lung Cancer","Genitourinary Cancer","Gynecological Cancer","Upper Aerodigestive Tract Cancer","Pancreatobiliary Gastrointestinal Cancer","Rare Cancer","Carcinoma of Unknown Primary",[420,211,429,157,422,423,424,425,430,426,431],"Non- small Cell Lung Cancer","Melanoma Cancer","Unknown Primary Cancer","2025-01-30",{"date":434,"type":35},"2025-01-31",{"date":436,"type":35},"2013-11-01",{"date":438,"type":20},"2025-11",{"name":440,"class":42},"University Health Network, Toronto",{"id":442,"slug":443,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":449,"targetDuration":53,"studyType":108,"phases":4,"briefSummary":450,"conditions":451,"keywords":453,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":99},"100511505","versatile-ampification-single-molecule-detection-in-liquid-biopsy-100511505","NCT05940311","Versatile Ampification Single-Molecule Detection in Liquid Biopsy","Versatile Ampification Method for Single-Molecule Detection in Liquid Biopsy","VerSiLiB","Inclusion Criteria:\n\n* age: ≥ 18\n* PFS≤2\n* Patients willing to sign an informed consent;\n* Confirmed (cytologically or histologically) cutaneous melanoma diagnosis\n* Confirmed BRAF p. V600E tumor status\n* Eligible for BRAFi\u002FMEKi treatment or Immune checkpoint blockade in either the adjuvant or advanced settings (the latter typically stages III\u002FIV, high risk).\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C8 weeks\n* Other clinical conditions preventing blood drawing compliance, as per physician's choice.",{"count":229,"type":20},"The trial will test a paradigm-changing in vitro diagnostic device for Liquid Biopsy enabling facile simultaneous detection of protein and nucleic acid analytes with sensitivity at single-molecule level, e.g. not achievable with any alternative technology. A novel affinity-mediated transport amplification (AMT) method will be tested allowing for the multiplexed quantification of rare biomarkers circulating in blood. The Versilib AMT photonic biosensor will test two analytes: the known actionable DNA mutation BRAF p.V600E, and a melanoma-restricted protein antigen. The results will be compared to digital PCR and ELISA methods.",[452,26,182,183],"Liquid Biopsy",[454],"BRAFV600E","2024-11-25",{"date":457,"type":35},"2024-11-27",{"date":459,"type":35},"2022-04-27",{"date":461,"type":20},"2026-03-31",{"name":463,"class":42},"Regina Elena Cancer Institute",{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":11,"sex":16,"minAge":470,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":21,"phases":473,"briefSummary":474,"conditions":475,"keywords":476,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":43},"100567330","dermasensor-postmarket-surveillance-study-100567330","NCT06666790","DermaSensor Postmarket Surveillance Study","Inclusion Criteria:\n\n1. Men or women of any ethnic group aged 40 and older\n2. Primary skin lesion suspicious for melanoma\n3. Patient is willing and able to read, understand, and sign the informed consent form (ICF)\n\nExclusion Criteria:\n\n1. Lesion is not accessible to the DermaSensor device Handheld Unit and tip (e.g., inside ears, under nails, etc.)\n2. Lesion is on areas of psoriasis, eczema, acne, or similar inflammatory skin conditions that may impede appropriate DermaSensor device tip placement on the lesion.\n3. Lesion is greater than 15mm in diameter at the widest point.\n4. Lesion has a targeted area less than 2.5mm in diameter where the DermaSensor device tip cannot be placed entirely within the border of the targeted area of the lesion.\n5. Lesion has no contiguous area of at least 2.5mm due to ulceration, erosion or liquid discharge (e.g., blood).\n6. Lesion is covered by a crust or scale, and lesion surface cannot be cleared of crust or scale such that there is a contiguous area of at least 2.5mm of cleared intact skin that is free of any crust, ulceration, erosion or liquid discharge (e.g., blood).\n7. Lesion is obstructed by foreign matter that cannot be non-invasively removed (e.g., tattoo, splinter, etc.)\n8. Lesion is not completely cleared of (i.e., free of any remaining residue) dermoscopy oils, makeup, sunscreen, other topical solutions or powders, markings, and staining treatments (e.g., iodine).\n9. Lesion is located on acral skin (e.g., sole or palms).\n10. Lesion is located within 10mm of the eye.\n11. Lesion is on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention.\n12. Lesion is located on mucosal surfaces (e.g. genitals, lips).\n13. Lesion is located in an area with acute sunburn.\n14. Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent and\u002For completing any required follow-up visits","40 Years",{"count":472,"type":20},396,[23],"The objective of this study is to evaluate the sensitivity of the DermaSensor device and Investigators when used on skin lesions concerning for melanoma.",[256],[477,478,479],"medical device","skin cancer detection","elastic scattering spectroscopy","2024-10-29",{"date":482,"type":35},"2024-10-31",{"date":484,"type":35},"2024-10-08",{"date":486,"type":20},"2027-09-10",{"name":488,"class":169},"DermaSensor, Inc.",{"id":490,"slug":491,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":21,"phases":499,"briefSummary":500,"conditions":501,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":379},"100489174","immunological-functionnal-test-validation-to-predict-melanoma-metastatic-patient-response-to-checkpoint-inhibitors-100489174","NCT05649683","Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors","Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors - Melanoma Quantiferon","mela-quantif","Inclusion\n\n* persone of major age,\n* advanced melanoma confirmed,\n* RECIST 1.1 disease,\n* first line treatment\n\nExclusion Criteria:\n\n* occular and mucosal melanoma,\n* previous checkpoint inhibitor treatment,\n* active brain metastasis,\n* concomitant immunosuppressive treatment",{"count":498,"type":20},60,[23],"Checkpoint inhibitor such as anti-CTLA-4 and anti-PD-1 are known to block inhibitory signals and increase the immune antimutoral response. Nivolumab and Ipilimumab association is considered as a more efficient immunotherapy to treat advanced melanoma. This combined immunotherapy is also responsible of severe immunes toxicyties. Identification of predictives biomarqueurs remains a challenge to predict the balance between tolerability and efficency. Previous data showed that advanced melanoma patient had lower level of Th1 cytokines that predict a less efficient immune system than healthy donors. The second point was that high level of Th1 and Th17 cytokines were correlate to a better tumor response. The last point was that patients with severe immune toxicity showed an increase of IL-6 and IL17a production. The investigators would like to identify the predictive values of Th1, Th2 and Th17 at the begining and during the combined immunotherapy and correlate these cytokines levels secretions to a potential efficient tumor response or to the emergence of induced immunes toxicities. This study is an original approach using functionnal test to predict the balance between efficienty and tolerability.",[26],"2024-06-03",{"date":504,"type":35},"2024-06-04",{"date":506,"type":35},"2023-01-31",{"date":508,"type":20},"2027-06-01",{"name":241,"class":42}]