[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-melanoma-stage-iv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-melanoma-stage-iv":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100570531","phase-2-phase-2b-of-rapa-201-cell-therapy-in-post-pd-l-1-melanoma-100570531",false,"NCT06708455","Phase 2b of RAPA-201 Cell Therapy in Post-PD-(L)-1 Melanoma","Phase 2 Trial of Autologous Rapamycin-Resistant Th1\u002FTc1 (RAPA-201) Cell Therapy of PD-(L)1 Resistant Malignant Melanoma","Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months.\n3. Patients with unresectable or metastatic melanoma (Stage IIIc or Stage IV).\n4. Prior to enrollment, documented refractory status to the most recent regimen, which must include an anti-PD-(L)1 monoclonal antibody, as defined by lack of response after at least two cycles of therapy or relapse within 12-months of initiation of the anti-PD- (L)1-containing therapy.\n5. For patients with BRAF V600 mutation-positive tumors, prior therapy with a BRAF inhibitor alone or in combination with a MEK inhibitor.\n6. Presence of measurable disease to permit monitoring by iRECISTv1.1 Criteria.\n7. Must have a potential source of autologous T cells potentially sufficient to manufacture RAPA-201 cells, as defined by a circulating absolute lymphocyte count (ALC) of ≥ 500 cells\u002FμL.\n8. Patients must be ≥ two weeks from last solid tumor cancer chemotherapy, major surgery, radiation therapy and\u002For participation in investigational trials.\n9. Patients must have recovered from clinical immunotherapy-related toxicities \\[resolution of CTCAE (v5) toxicity to a value of ≤ 1; with the exception of alopecia, vitiligo, and endocrinopathy stable on hormone replacement\\].\n10. Hematologic parameters of: Absolute neutrophil count (ANC) of ≥ 1500 cells\u002FμL, Platelet count ≥ 100,000 cells\u002FμL, and Hemoglobin of ≥ 9 grams\u002FμL.\n11. Calculated creatinine clearance of ≥ 40 mL\u002Fmin.\n12. Ejection fraction (EF) by MUGA or 2-D echocardiogram within institution normal limits, with an EF level of ≥ 45%.\n13. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) (or ≤ ULN if patient has liver metastasis).\n14. Bilirubin ≤ 2.0 mg\u002FdL (if Gilbert\\'s disease, ≤ 3.0 mg\u002FdL).\n15. No history of abnormal bleeding tendency (as defined by any inherited coagulation defect or history of internal bleeding).\n16. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n\nExclusion Criteria\n\n1. Other active malignancy (except non-melanoma skin cancer).\n2. Life expectancy \\< 3 months.\n3. Seropositivity for HIV, hepatitis B, or hepatitis C, unless such conditions are in stable condition using adequate treatment.\n4. Uncontrolled hypertension.\n5. Cerebrovascular accident within 6 months of enrollment.\n6. Myocardial infarction within 6 months of enrollment.\n7. NYHA class III\u002FIV congestive heart failure.\n8. Uncontrolled angina\u002Fischemic heart disease.\n9. Cancer metastasis to the central nervous system, unless such metastasis has been adequately treated.\n10. Pregnant or breastfeeding patients.\n11. Women of childbearing potential, or males who have a partner of childbearing potential, who are unwilling to practice contraception.\n12. Patients may be excluded at the discretion of the PI or if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.","ALL","18 Years",{"count":19,"type":20},65,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The protocol is a Simon's 2-stage, non-randomized, open label, multi-site, phase 2 trial for patients with advanced metastatic, recurrent and unresectable malignant melanoma that has recurred or relapsed after prior anti-PD-(L)1 therapy.",[26,27,28,29],"Malignant Melanoma With Metastasis","Malignant Melanoma","Malignant Melanoma Stage IIIc","Malignant Melanoma Stage IV",[31,32,33,34,35],"Adoptive T Cell Therapy","Rapamycin","Regenerative Medicine","Malignant Malanoma","RMAT","NOT_YET_RECRUITING","2026-03-17",{"date":39,"type":40},"2026-03-19","ACTUAL",{"date":42,"type":20},"2027-03-01",{"date":44,"type":20},"2029-09-30",{"name":46,"class":47},"Rapa Therapeutics LLC","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":5},"100609484","phase-2-68gaga-fapi-total-body-petct-for-better-and-faster-imaging-in-cancer-100609484","NCT07215182","[68Ga]Ga-FAPI Total Body PET\u002FCT for Better and Faster Imaging in Cancer","[68Ga]Ga-FAPI PET\u002FCT for Response Evaluation During Immune Checkpoint Inhibitor Therapy in Malignant Melanoma","BEFAST","Inclusion Criteria:\n\n1. Male or female, \\>\u002F=18 years old\n2. Histological verified metastatic or locally advanced malignant melanoma\n3. Visible malignant lesions on \\[18F\\]FDG PET\u002FCT or CT\n4. Subjects must be considered inoperable\n5. Subjects must be considered medically suitable for ICT\n6. Subjects must be able to read and understand the patient information in Danish to give informed consent\n\nExclusion Criteria:\n\n1. Ocular or mucosal melanoma\n2. Other concurrent cancer disease\n3. Previous systemic oncological treatment with ICT\n4. Pregnancy or lactation\n5. Weight more than the maximum limit of a PET\u002FCT-scanner bed (140 kg)\n6. History of allergic reaction due to compounds similar to the chemical composition of \\[68Ga\\]Ga-FAPI- 46",{"count":58,"type":20},20,[23],"The goal of this clinical trial is to investigate the use of the tracer \\[68Ga\\]Ga-FAPI-46 for PET\u002FCT-imaging in response evaluation of patients with advanced stage malignant melanoma treated with immune checkpoint inhibitor therapy (ICT). The main question it aims to answer is:\n\n• Can \\[68Ga\\]Ga-FAPI-46 PET\u002FCT improve response evaluation in patients suffering from advanced stage malignant melanoma treated with ICT and potentially serve as a biomarker.\n\nResearchers will compare findings on the experimental \\[68Ga\\]Ga-FAPI-46 PET\u002FCT with findings on standard imaging (\\[18F\\]FDG PET\u002FCT).\n\nParticipants will undergo:\n\n* Two \\[68Ga\\]Ga-FAPI-46 PET\u002FCT scans: one before treatment initiation with ICT and one after three months.\n* Two blood samples\n* Passive follow-up 6 months after the last scan \\[68Ga\\]Ga-FAPI-46 PET\u002FCT",[29],[63,64,65,66],"FAPI PET\u002FCT","Immune checkpoint inhibitor therapy","malignant melanoma","response evaluation","RECRUITING","2025-10-02",{"date":70,"type":40},"2025-10-10",{"date":72,"type":40},"2025-08-15",{"date":74,"type":20},"2027-02-20",{"name":76,"class":77},"Barbara Malene Fischer","OTHER"]