[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-cutaneous-melanoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-cutaneous-melanoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100640848","phase-1-circadian-optimized-light-therapy-for-the-treatment-of-patients-with-advanced-melanoma-receiving-tumor-infiltrating-lymphocyte-therapy-100640848",false,"NCT07628894","Circadian-Optimized Light Therapy for the Treatment of Patients With Advanced Melanoma Receiving Tumor-Infiltrating Lymphocyte Therapy","A Single-Center, Prospective Pilot Trial of Circadian-Optimized Light Therapy (COLT) in Patients Undergoing Tumor-Infiltrating Lymphocyte (TIL) Therapy for Metastatic Melanoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Age: ≥ 18 years\n* Ability to read and understand English for questionnaires\n* Progression on or after immune checkpoint inhibitor therapy\n* Deemed eligible and consented for standard-of-care TIL therapy (lifileucel\u002FAmtagvi)\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (typically required for TIL therapy; confirm with clinical standards of practice \\[SOP\\])\n\nExclusion Criteria:\n\n* Explicit Munich Chronotype Questionnaire (MCTQ) cutoffs (\\\u003C 2:00, \\> 5:00)\n* Use of melatonin or pharmacologic sleep aids (e.g., zolpidem, trazodone, benzodiazepines) within 14 days prior to enrollment\n* Night shift work within the past 30 days or expected during the intervention\n* Travel across ≥ 2 time zones within the past 14 days\n* Diagnosed or suspected untreated moderate to severe obstructive sleep apnea\n* History of mania, hypomania, bipolar disorder, migraine (with or without photophobia), or active seizure disorder\n* Active psychosis, suicidal ideation, or recent psychiatric hospitalization (\\\u003C 3 months)\n* Ocular conditions exacerbated by bright light exposure\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","ALL","18 Years",{"count":19,"type":20},8,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial tests the effect of Circadian-Optimized Light Therapy (COLT) in conjunction with standard of care tumor-infiltrating lymphocytes (TIL) therapy in treating patients with melanoma that may have spread from where it first started to nearby tissue, lymph nodes or distant parts of the body (advanced). Circadian rhythm is the body's natural 24 hour clock which helps keep the body operating on a healthy wake-sleep cycle. Exposure to morning light has been shown to have a positive impact. Patients with advanced cancers often experience circadian disruption, including exposure to hospital-related light, treatment side effects, and inflammation. TIL are made by collecting and growing specialized T cells (a type of white blood cell) from a patient's tumor and given back to the patient to help stimulate the immune system in different ways to stop tumor cells from growing. However, disruptions in the circadian rhythm may impact the effectiveness of TIL therapy. COLT is a home-based digital intervention that delivers circadian-effective morning light using the Circadian OS iPad application. Daily light exposure may help prevent circadian disruption and improve immune and inflammatory responses. Adding COLT sessions to standard of care therapy with TIL may be safe and tolerable in patients with advanced melanoma.",[26,27,28,29],"Advanced Cutaneous Melanoma","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Metastatic Cutaneous Melanoma","NOT_YET_RECRUITING","2026-06-01",{"date":33,"type":34},"2026-06-05","ACTUAL",{"date":36,"type":20},"2026-12-23",{"date":38,"type":20},"2027-07-05",{"name":40,"class":41},"City of Hope Medical Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":5},"100604884","phase-2-time-of-day-specified-immunotherapy-for-advanced-melanoma-the-time-trial-100604884","NCT07155317","Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial","The TIME Trial - Phase II Randomized Controlled Trial of Time-of-Day Specified Immunotherapy for Advanced Melanoma","Inclusion Criteria:\n\n* Pathologically confirmed American Joint Committee on Cancer (AJCC) 8th edition stage IV unresectable cutaneous, acral, or mucosal melanoma\n* No uveal melanoma\n* Patients with asymptomatic, non-hemorrhagic brain metastases \\\u003C 2 cm are eligible\n* No prior immunotherapy within 1 year, (serine\u002Fthreonine-protein kinase B-raf \\[BRAF\\]\u002Fmitogen-activated protein kinase \\[MEK\\] inhibitors allowed)\n* Eastern Cooperative Oncology Group (ECOG) 0-1\n* Age ≥ 18\n* Adequate organ function to receive ipilimumab\u002Fnivolumab\n\nExclusion Criteria:\n\n* Immunosuppression (\\> 10mg prednisone daily)\n* Active autoimmune disease that would preclude the administration of immunotherapy\n* Active leptomeningeal disease",{"count":51,"type":20},99,[53],"PHASE2","This phase II trial tests the safety and effectiveness of giving ipilimumab and nivolumab in the morning compared to other times of day in treating patients with melanoma that is stage IV or that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread. While some patients have impressive outcomes with both of these drugs, over 40% of patients do not experience any clinical benefit. Studies have shown that the time of day that vaccines and other therapies are given have had an impact on response and survival. It is not known, however, whether time of day has an impact on response to immune checkpoint inhibitors, such as ipilimumab and nivolumab. Giving ipilimumab and nivolumab earlier in the day compared to later in the day may improve response to treatment and survival in patients with stage IV or unresectable melanoma.",[56,26,57,28,58,29,59,60,61,62],"Advanced Acral Melanoma","Advanced Mucosal Melanoma","Metastatic Acral Melanoma","Metastatic Mucosal Melanoma","Unresectable Acral Melanoma","Unresectable Cutaneous Melanoma","Unresectable Mucosal Melanoma","RECRUITING","2025-11-10",{"date":66,"type":34},"2025-11-12",{"date":68,"type":34},"2025-10-29",{"date":70,"type":20},"2027-12-31",{"name":72,"class":41},"Emory University"]