[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-melanoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-melanoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,44,80,106,138,169,198,225,250,277,299,321,344,376,406,431,458,485,506,536,561,593,615],{"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":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100589945","phase-2-a-clinical-study-of-intismeran-autogene-v940-and-pembrolizumab-mk-3475-in-people-with-melanoma-v940-012interpath-012-100589945",false,"NCT06961006","A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012\u002FINTerpath-012)","A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants With First-Line Advanced Melanoma (INTerpath-012)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has unresectable and histologically confirmed Stage III or IV cutaneous melanoma per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.\n* Has been untreated for melanoma except if participant received prior adjuvant or neoadjuvant therapy with targeted therapy or immunotherapy (such as anti-cytotoxic T-lymphocyte-associated protein \\[CTLA-4\\], anti-programmed cell death 1 protein \\[PD-1\\] therapy or interferon), and only if relapse did not occur within 12 months after treatment discontinuation.\n* Have documentation of serine\u002Fthreonine-protein kinase B-raf (BRAF) V600-activating mutation status or had BRAF V600 mutation testing per local institutional standards during the screening period (participants with BRAF mutation positive melanoma as well as BRAF wild-type or unknown are eligible).\n* Have the presence of at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator\u002Fradiology assessment.\n* Provides tumor tissue (preferably from a metastatic site and, if not available, from the primary tumor) that is suitable for next generation sequencing and biomarker analysis as required for this study.\n* Participants with human immunodeficiency virus (HIV) must have well controlled HIV on antiretroviral therapy (ART).\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has clinically significant heart failure, defined as New York Heart Association class III or IV, within the past 6 months, unless the disease is well controlled in the opinion of the investigator.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Has ocular or mucosal melanoma.\n* Received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 2 weeks of the Screening blood sample (including the blood sample for V940 generation).\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, lymphocyte activation gene 3 \\[LAG-3\\], tumor necrosis factor receptors \\[OX-40 or CD137\\]), with some exceptions.\n* Received prior systemic anticancer therapy for melanoma before randomization, with some exceptions.\n* Received prior radiotherapy within 2 weeks of start of study intervention or has ongoing radiation related toxicities.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Received prior treatment with another universal or personalized cancer vaccine.","ALL","18 Years",{"count":19,"type":20},160,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Researchers want to learn if intismeran autogene with pembrolizumab can stop advanced melanoma from growing or spreading. Melanoma is a type of skin cancer. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. A standard (or usual) treatment for advanced melanoma is immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Intismeran autogene is a study treatment designed to help a person's immune system attack their specific cancer. Pembrolizumab is an immunotherapy.\n\nThe goal of this study is to learn if people who receive intismeran autogene with pembrolizumab live longer without the cancer growing or spreading than people who receive placebo with pembrolizumab. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment.",[26],"Malignant Melanoma",[28,29,30],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","RECRUITING","2026-07-01",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2025-05-29",{"date":39,"type":20},"2031-09-05",{"name":41,"class":42},"Merck Sharp & Dohme LLC","INDUSTRY",38,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100564996","phase-1-a-phase-i-first-in-human-study-of-cba-1205-anti-dlk1-monoclonal-antibody-in-patients-with-advanced-solid-tumors-hepatocellular-carcinoma-hcc-melanoma-and-pediatric-cancer-100564996","NCT06636435","A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors, Hepatocellular Carcinoma (HCC), Melanoma, and Pediatric Cancer","A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors.","Inclusion Criteria:(Part 1-4)\n\n* Patients who provide voluntary written informed consent to participate in the study\n* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of≤1\n* Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (creatinine: ≤ ULN ×1.5)\n* Patients who meet the following laboratory criteria of bone marrow function as evidenced by laboratory data obtained within 7 days before enrollment: Neutrophil count;≥1500\u002FμL, Platelet count; ≥75000\u002FμL, Hemoglobin;≥9.0 g\u002FdL.\n* Patients having Solid Tumors with no standard therapy available or refractory or intolerable to standard therapy (Part2, 3)\n* Patients with Child-Pugh A or B (Part2, 3)\n* Patients with Malignant Melanoma who are refractory or intolerant to standard therapy (Part 4)\n\nInclusion Criteria:(Part 5)\n\n* Patients who provide voluntary written informed consent to participate in the study from both the subject (if aged 16 years or older) and their legal representatives\n* Japanese patients aged 2 years or older and under 20 years at the time of informed consent\n* Patients with a Lansky Performance Status (LPS) of ≥70 (for patients aged 15 years or younger) or a Karnofsky Performance Status (KPS) of ≥70 (for patients aged 16 years or older)\n* Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (eGFR ≥60 mL\u002Fmin\u002F1.73 m²)\n* Pediatric patients with cancers with no standard therapy available or refractory or intolerable to the standard therapy\n\nExclusion criteria: (Part1-5)\n\n* Patients who have undergone major surgery within 28 days before enrollment\n* Patients who have received anticancer treatment with surgical therapy, radiation therapy, and\u002For drug therapy within 14 days before enrollment\n* Patients who have received anticancer treatment with immune checkpoint inhibitor, etc. within 28 days before enrollment\n* Patients with Grade 2 or higher concurrent disease or prior therapy-related toxicity\n* Patients who have received any other investigational product within 28 days before enrollment\n* Patients with current or previous inadequately controlled or clinically significant cardiac disease\n* Patients who, in the opinion of the investigator or subinvestigator, is not appropriate","2 Years",{"count":53,"type":20},66,[55],"PHASE1","In this first-in-human, muticenter, non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 5 parts (Part 1-5). The purpose of this FIH study is to evaluate the safety and tolerability profile of CBA-1205.",[58,59,26,60],"Solid Tumors","Hepatocellular Carcinoma (HCC)","Pediatric Cancer",[62,63,64,65,66,67,68,69,60],"DLK1","First in human","Phase I","Antibody","solid tumor","Hepatocellular Carcinoma","CBA-1205","Melanoma","2026-06-15",{"date":72,"type":35},"2026-06-17",{"date":74,"type":35},"2020-06-01",{"date":76,"type":20},"2027-06-30",{"name":78,"class":42},"Chiome Bioscience Inc.",5,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100527661","phase-1-a-phase-1-of-ctx-8371-in-patients-with-advanced-malignancies-100527661","NCT06150664","A Phase 1 of CTX-8371 in Patients With Advanced Malignancies","A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients With Advanced Malignancies","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is relapsed\u002Frefractory to standard therapy or for which no effective standard therapy is available, including\n\n   1. Malignant Melanoma (MM)\n\n      * Patients who have progressed after a minimum of 2 doses of a PD-1\u002FPD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1\u002FPD-L1 blocking antibody\n      * Patients must have had prior testing for BRAF V600 mutations. Patients with BRAF V600 activating mutation must have received prior therapy with a BRAF\u002FMEK inhibitor\n      * Uveal and mucosal melanoma are excluded\n   2. Head and Neck squamous cell carcinoma (HNSCC)\n\n      * HNSCC of oral cavity, oropharynx, hypopharynx, or larynx\n      * Patients who have progressed after a minimum of 2 doses of a PD-1\u002FPD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1\u002FPD-L1 blocking antibody\n      * Patients must have received prior treatment with platinum-based chemotherapy\n   3. Non-Small Cell Lung Cancer (NSCLC)\n\n      * Patients who have progressed after a minimum of 2 doses of a PD-1\u002FPD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1\u002FPD-L1 blocking antibody\n      * Patients must have received prior treatment with platinum-based chemotherapy\n   4. Triple Negative Breast Cancer (TNBC)\n\n      * ER\u002FPR and HER2 status should be defined by ASCO\u002FCAP guidelines (JCO Allison et al 2020)\n      * Patients with HER2-low cancers (HER2 IHC 1+ or 2+\u002FISH negative) are excluded\n      * Patients must have received prior sacituzumab govitecan and if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy\n   5. Classical Hodgkin Lymphoma (HL)\n\n      * Patients must have received at least two prior systemic therapies including brentuximab vedotin (if eligible) and a prior PD-1 inhibitor\n      * Patients must have experienced less than a CR (according to Lugano criteria) to anti- PD-1 treatment\n   6. (Cohort 2 Dose Expansion): Non-Small Cell Lung Cancer (NSCLC)\n\n      * Patients who have progressed after a minimum of 2 doses of a PD-1\u002FPD-L1 treatment\n      * Patients must have received prior treatment with platinum-based chemotherapy\n   7. (Cohort 2 Dose Expansion) Triple Negative Breast Cancer (TNBC)\n\n      * ER\u002FPR and HER2 status should be defined by ASCO\u002FCAP guidelines (JCO Allison et al 2020)\n      * Patients must have received prior sacituzumab govitecan and if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy\n      * Patients with HER2-low tumors (HER2 IHC 1+ or 2+\u002FISH negative) need to have received fam-trastuzumab deruxtecan (Enhertu)\n   8. (Cohort 2 Dose Expansion) Classical Hodgkin's Lymphoma (HL)\n\n      * Patients must have received at least two prior systemic therapies including brentuximab vedotin (if eligible) and a prior PD-1 inhibitor.\n      * Patients must have received at least 12 weeks of treatment with a PD-1\u002FPD-L1 inhibitor as a monotherapy or in combination and had at least stable disease or progressive disease (PD) with overall clinical benefit.\n3. Patients with NSCLC, MM, TNBC, and HNSCC must have measurable disease per RECIST 1.1. Patients with HL must have at least one measurable lesion \\> 1.5 cm for nodal, \\> 1.0 cm for extranodal FDG-avid disease by the Lugano (2014) response criteria. Tumor sites that are considered measurable must not have received prior radiation\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n5. Adequate bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109\u002FL, platelet count of ≥ 100.0×109\u002FL, and hemoglobin of ≥ 9.0 g\u002FdL (with or without transfusion)\n\n   a. (Cohort 2 Dose Expansion) Adequate bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109\u002FL, platelet count of ≥ 100.0×109\u002FL, and hemoglobin of ≥ 9.0 g\u002FdL (with or without transfusion) within 2 weeks from the first dose of CTX-8371.\n\n   \\- Blood transfusion is not allowed within 2 weeks from the first dose of CTX-8371\n6. Adequate hepatic function defined as serum total bilirubin ≤ 1.5 × ULN, AST\u002FALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)\n7. Adequate renal function defined as creatinine clearance ≥ 30mL\u002Fmin by Cockcroft-Gault equation\n8. Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commits to use 2 acceptable forms of birth control (defined as the use of an intrauterine device (IUD), a barrier method with spermicide, condoms, any form of hormonal contraceptives) or abstinence for the duration of the study and for 4 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment\n9. Female patients who are women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening within 7 days of dosing with CTX-8371\n10. Last dose of previous PD-1 or PD-L1 therapy ≥ 28 days, other anticancer therapy \\> 21 days (or 2 half-lives for proteins, whichever is longer), radiotherapy \\>21 days (concurrent localized palliative radiotherapy is allowed during CTX-8371 treatment), or surgical intervention \\>21 days prior to the first dose of CTX-8371\n11. Resolution of all prior anti-cancer therapy toxicities ≤ Grade 2\n12. Life expectancy ≥ 12 weeks\n13. Capable of understanding and complying with protocol requirements\n14. Signed and dated institutional review board (IRB)\u002Findependent ethics committee (IEC)-approved informed consent form (ICF) before any protocol-directed screening procedures are performed\n\nExclusion Criteria:\n\n1. Developed clinically significant adverse reaction to PD-1 or PD-L1 therapy, including immune related adverse reactions, which led to discontinuation of treatment\n2. Systemic therapy with immunosuppressive agents within 7 days before the start of CTX-8371 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement for patients with adrenal insufficiency are allowed\n3. Patient is a pregnant or lactating WOCBP\n4. Prior organ transplantation\n5. Patients with evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection. Patients with positive HBsAg and\u002For detectable HBV DNA are eligible only if adequately controlled on antiviral therapy according to institutional standards and liver function eligibility criteria are also met. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll.\n6. Active autoimmune disease or medical conditions requiring chronic steroid (i.e., \\> 10 mg\u002Fday prednisone or equivalent) or immunosuppressive therapy. Patients with a prior history of autoimmune disease may be eligible following discussion with the Medical Monitor\n7. History of primary malignancy other than the malignancy under study will be excluded, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\>90%). Prior malignancy history will be evaluated on a case-by-case basis by the Sponsor Medical Monitor.\n8. Symptomatic or uncontrolled central nervous system and brain metastasis or active leptomeningeal disease. Patients with equivocal findings or with confirmed brain metastases are eligible for the study provided that they are asymptomatic and radiologically and neurologically stable without the need for corticosteroid treatment or seizure prophylaxis for ≥4 weeks before the first dose of study drug. Prior treatment with either surgery or radiation is permitted and all patients with a history of CNS or brain lesions require imaging during screening to confirm stability.\n9. Other medical condition that in the opinion of the Investigator and\u002For Sponsor Medical Monitor may interfere with the conduct and\u002For interpretation of the current study, including:\n\n   * Congestive heart failure (\\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or clinically significant cardiac arrhythmias\n   * QTc interval (using Fridericia correction calculation) \\> 480 msec",{"count":88,"type":20},85,[55],"This is a Phase 1, open-label, first-in-human study of CTX-8371 administered as a monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 cohorts: Dose Escalation and Dose Expansion.",[92,93,94,95,26],"Non Small Cell Lung Cancer","Triple Negative Breast Cancer","Hodgkin Lymphoma","Head and Neck Squamous Cell Carcinoma","2026-04-15",{"date":98,"type":35},"2026-04-20",{"date":100,"type":35},"2024-03-19",{"date":102,"type":20},"2027-05",{"name":104,"class":42},"Compass Therapeutics",9,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":137},"100591794","reducing-symptom-burden-through-physical-exercise-in-melanoma-patients-100591794","NCT06985056","Reducing Symptom Burden Through Physical Exercise in Melanoma Patients","Reducing Symptom Burden Through Physical Exercise in Melanoma Patients Under Immuno- or Targeted Therapy","RESPECT","Inclusion Criteria:\n\n* patients ≥ 18 years with malignant melanoma (Stage IIb - IV) receiving adjuvant or palliative immunotherapy or targeted therapy\n* patients with ECOG level 0-2\n* patients already on the same treatment protocol for at least 3 months and no more than 9 months\n* sufficient knowledge of German\n* completed and signed written consent form and completed medical history form\n* medical clearance for the exercise program and performance diagnostics\n* ability to participate in the exercise program\n* willingness to visit the study hospital for training sessions and examinations\n\nExclusion Criteria:\n\n* confirmation of contraindications for physical exercise by the attending physician (e.g. fracture risk in the case of bone metastases)\n* untreated, symptomatic, known brain metastases\n* severe neurological or cardiac impairment according to ACSM criteria\n* confirmation of respiratory insufficiency by the attending physician\n* life expectancy less than 3 months\n* physical or mental conditions that would not allow implementation of the exercise program or study protocol\n* excessive physical activity (i.e. \\>150 minutes\u002Fweek of moderate to intense physical activity and systematic intense strength\u002Fendurance training at least twice a week for one hour)",{"count":115,"type":20},104,[117],"NA","The aim of the clinical trial is to determine whether regular exercise can reduce fatigue in adult patients with stage IIb-IV melanoma undergoing immunotherapy or targeted therapy. Additionally, we will investigate whether a supervised exercise program improves patients' quality of life, cognitive skills, and physical fitness compared to a control group without structured exercise. We will also examine other health outcomes and various blood parameters, such as interleukins and metabolites, to understand how regular activity can affect metabolism and immune function.\n\nAfter the initial assessment at the clinic, patients will be randomly assigned to two groups. Those in the intervention group will participate in a 12-week exercise program, which includes a 60-minute personalized and supervised online training session twice a week. In weeks 3, 6, and 9, one training session will be held at the clinic. Furthermore, patients in the intervention group are encouraged to complete a self-administered 20-minute exercise session once a week. The control group will not receive a supervised exercise program. Following the 12-week intervention period, another assessment will be conducted at the clinic. All patients will then enter a 6-week follow-up phase, during which neither group will receive supervised exercise training. After this follow-up phase, a final assessment of all outcomes will take place at the clinic.",[26],[121,122,123,124,125,69,126],"Exercise","Fatigue","Physical Activity","Checkpoint Inhibitors","BRAF\u002FMEK Inhibitors","Quality of Life","2026-03-26",{"date":129,"type":35},"2026-03-27",{"date":131,"type":35},"2025-08-18",{"date":133,"type":20},"2027-11",{"name":135,"class":136},"Universität Duisburg-Essen","OTHER",1,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":148,"conditions":149,"keywords":153,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":137},"100570531","phase-2-phase-2b-of-rapa-201-cell-therapy-in-post-pd-l-1-melanoma-100570531","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.",{"count":146,"type":20},65,[23],"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.",[150,26,151,152],"Malignant Melanoma With Metastasis","Malignant Melanoma Stage IIIc","Malignant Melanoma Stage IV",[154,155,156,157,158],"Adoptive T Cell Therapy","Rapamycin","Regenerative Medicine","Malignant Malanoma","RMAT","NOT_YET_RECRUITING","2026-03-17",{"date":162,"type":35},"2026-03-19",{"date":164,"type":20},"2027-03-01",{"date":166,"type":20},"2029-09-30",{"name":168,"class":42},"Rapa Therapeutics LLC",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":185,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":197},"100621518","phase-1-an-phase-ibii-clinical-trial-of-tcc1727-combination-therapy-in-advanced-solid-tumors-100621518","NCT07371663","An Phase Ib\u002FII Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors","An Open-Label, Multicenter Phase Ib\u002FII Clinical Trial of TCC1727 in Combination With Benmelstobart\u002FOlaparib\u002FTopotecan for Advanced Solid Tumors","Inclusion Criteria:\n\n* -Voluntarily participate in this study and sign the informed consent form.\n* At the time of signing the informed consent, subjects must be ≥18 years of age (inclusive).\n* Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumors and have experienced disease progression following prior standard anti-tumor therapy; or subjects must have no available standard therapy, be intolerant to or refuse standard therapy, or meet the specific requirements for the corresponding phase and group as follows:\n\n  * Phase Ib :Subjects with advanced, recurrent, or refractory solid tumors, which may include (but are not limited to) the specific tumor types in Phase II.\n  * Phase II Study:Based on different combination therapy groups, subjects with the following specific tumor types (different population cohorts):\n\nTCC1727 combined with Benmelstobart Group:\n\nThe study will enroll subjects with advanced solid tumors lacking standard therapies, including but not limited to non-small cell lung cancer (NSCLC), endometrial cancer, and other advanced solid tumors (e.g., colorectal cancer, urothelial carcinoma, gastric cancer, and gastroesophageal junction cancer):\n\nCohort 1 (NSCLC):Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC who are eligible for second- or third-line therapy. Patients must have received prior therapy with an anti-PD-(L)1-containing regimen (either as monotherapy or in combination) and a platinum-based doublet regimen for locally advanced or metastatic NSCLC.\n\nSubgroup 1: ATM mutation. Subgroup 2: ATM wild-type, with or without other DDR functional defects.\n\nCohort 2 (Endometrial Cancer):Patients with histopathologically confirmed recurrent or metastatic advanced endometrial cancer who have received at least one prior platinum-based chemotherapy and immune checkpoint inhibitor (PD-1 or PD-L1) therapy (sequential or concurrent therapy allowed; sequential therapy refers to platinum-based chemotherapy followed by immune checkpoint inhibitor maintenance therapy).\n\nSubgroup 1: DDR functional defect, ATM wild-type or mutated. Subgroup 2: DDR functional normal.\n\nCohort 3 (Other Advanced Solid Tumors):Patients with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard therapy, are intolerant to standard therapy, have no standard therapy available, or for whom standard therapy is currently unsuitable.\n\nSubgroup 1: DDR functional defect, ATM wild-type or mutated. Subgroup 2: DDR functional normal.\n\nTCC1727 combined with Olaparib Tablets Group:\n\nThe study will enroll subjects with histopathologically confirmed recurrent ovarian cancer:\n\nCohort 4 (Ovarian Cancer):Subjects with histopathologically confirmed recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer:\n\nSubgroup 1: Subjects who have experienced disease progression after prior Olaparib Tablets therapy (maintenance or subsequent therapy). Subjects must not have received further treatment after progression on Olaparib Tablets.\n\nSubgroup 2: Subjects who have not received Olaparib Tablets and have primary platinum-resistant\u002Frefractory disease (recurrence within 6 months of last platinum-based therapy). Subjects must have received ≤3 prior lines of therapy since developing platinum resistance.\n\nTCC1727 combined with Topotecan Hydrochloride for Injection Group:\n\nThe study will enroll subjects with histopathologically or cytologically confirmed small cell lung cancer (SCLC):\n\nCohort 5 (SCLC):Subjects who have progressed after platinum-based chemotherapy combined with PD-(L)1 therapy, or subjects with extensive-stage SCLC who have relapsed or progressed within ≤6 months after first-line therapy.\n\n* At least one measurable lesion (per RECIST v1.1; lesions previously treated with local therapy may be considered target lesions if they show clear progression per RECIST v1.1).\n* Subjects must provide sufficient tumor tissue samples, including but not limited to fresh specimens (preferred) or formalin-fixed, paraffin-embedded (FFPE) tumor tissue obtained within approximately 24 months prior to randomization, unstained FFPE slides, or core needle biopsy tissue for biomarker testing.\n* ECOG performance status score of 0-1 within 7 days prior to the first dose of study drug.\n* Expected survival ≥12 weeks.\n* Ability to swallow tablets whole and maintain this method of administration.\n* Organ function within the following ranges within 7 days prior to the first dose of study drug (no blood component or growth factor therapy within 14 days prior to the first dose):\n\n  1. Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL;\n  2. White blood cell count (WBC) ≥3.0 × 10⁹\u002FL;\n  3. Platelet count ≥100 × 10⁹\u002FL;\n  4. Hemoglobin (Hb) ≥90 g\u002FL;\n  5. Serum albumin ≥30 g\u002FL;\n  6. Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for hepatocellular carcinoma or subjects with liver metastases);\n  7. ALT and AST ≤3 × ULN (≤5.0 × ULN for hepatocellular carcinoma or subjects with liver metastases);\n  8. Alkaline phosphatase (ALP) ≤2.5 × ULN (≤5 × ULN if bone metastases are present);\n  9. Serum creatinine ≤1.5 × ULN or creatinine clearance (CrCL) ≥60 mL\u002Fmin (Cockcroft-Gault formula);\n  10. APTT ≤1.5 × ULN and INR or PT ≤1.5 × ULN (for subjects not receiving anticoagulation therapy);\n  11. QTc \\\u003C450 ms (male) or \\\u003C470 ms (female), LVEF ≥50%.\n* For non-sterilized or fertile female subjects, medically approved contraception (e.g., intrauterine device, oral contraceptives, or condoms) must be used during the study and for 6 months after the last dose. Non-sterilized female subjects must have a negative serum HCG test within 72 hours before the first dose and must not be breastfeeding. Male subjects with fertile partners must use effective contraception during the study and for 3 months after the last dose.\n\nExclusion Criteria:\n\n* Known primary central nervous system (CNS) tumors (including meningeal tumors); symptomatic brain metastases, spinal cord compression, carcinomatous meningitis, or uncontrolled CNS metastases. Exceptions: Subjects with completely resected and\u002For irradiated CNS metastases that are stable or improved for ≥4 weeks before screening (no evidence of brain edema and no need for corticosteroids or anticonvulsants). Asymptomatic brain metastases \\\u003C1 cm in diameter without surrounding edema are also allowed.\n* Major surgery, radiotherapy, chemotherapy, or other investigational anti-tumor therapy completed \\\u003C4 weeks before the first dose (exceptions: small-molecule anti-tumor therapy completed \\>5 half-lives or \\>10 days before the first dose, whichever is longer; palliative radiotherapy completed \\>2 weeks before the first dose).\n* Use of strong CYP3A4 inhibitors or inducers within 14 days before the first dose (e.g., rifampin, rifapentine, St. John's wort, carbamazepine, phenytoin, barbiturates, ketoconazole, itraconazole, clarithromycin, voriconazole, atazanavir, ritonavir, saquinavir, grapefruit juice).\n* Any unresolved ≥Grade 2 toxicity (per CTCAE v5.0) from prior anti-tumor therapy (except alopecia, pigmentation, or laboratory abnormalities meeting inclusion criteria).\n* Inability to swallow tablets, gastrointestinal dysfunction, or any condition that may affect drug absorption (per investigator's judgment).\n* Uncontrolled severe diseases, including:\n\n  1. Poorly controlled hypertension (systolic BP ≥150 mmHg or diastolic BP ≥100 mmHg);\n  2. Clinically significant cardiovascular disease within 6 months before the first dose (e.g., myocardial infarction, severe\u002Funstable angina, stroke, ≥Grade 2 congestive heart failure \\[NYHA classification\\]);\n  3. Arrhythmia (≥Grade 2 per CTCAE v5.0, including QTcF ≥450 ms \\[male\\] or ≥470 ms \\[female\\]);\n  4. Unexplained fever ≥38.5°C within 14 days before the first dose or active infection requiring systemic therapy;\n  5. Active viral hepatitis (HBV DNA ≥500 IU\u002FmL for HBsAg-positive and\u002For anti-HBc-positive subjects; HCV RNA-positive for anti-HCV-positive subjects; antiviral therapy required for eligible HBV\u002FHCV-positive subjects);\n  6. Active syphilis;\n  7. Active tuberculosis;\n  8. Immunodeficiency (e.g., HIV-positive, congenital\u002Facquired immunodeficiency, organ transplant history);\n  9. Poorly controlled diabetes (fasting blood glucose \\>10 mmol\u002FL).\n* Uncontrolled pleural effusion, pericardial effusion, ascites, or recurrent ascites requiring drainage within 28 days before the first dose.\n* Significant bleeding symptoms or tendency within 3 months before the first dose.\n* Chronic systemic corticosteroid therapy (\\>10 mg prednisone equivalent daily) or immunosuppressive therapy within 14 days before the first dose.\n* Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., immunomodulators, corticosteroids, immunosuppressants). Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement for adrenal\u002Fpituitary insufficiency) is allowed. (Applies only to Ib Phase and Phase II TCC1727 + Benmelstobart groups.)\n* History of severe allergic reactions to study drugs or their excipients.\n* Other malignancies within 3 years before screening (except cured basal cell carcinoma, cervical carcinoma in situ, or thyroid papillary carcinoma).\n* Prior ≥Grade 3 immune-mediated adverse events (imAEs) or permanent discontinuation due to imAEs during anti-PD-(L)1 therapy.\n* Prior treatment with TCC1727, other ATR inhibitors, or cell cycle checkpoint inhibitors (e.g., ATM inhibitors, WEE1 inhibitors, CHK1\u002FCHK2 inhibitors).\n* Other severe physical\u002Fmental illnesses or factors that may increase study risk or interfere with results, or any condition deemed unsuitable by the investigator.\n\nAdditional exclusions:\n\n* Phase II Cohort 1 (NSCLC):Exclude subjects with known EGFR, ALK, ROS1, BRAF, MET, RET, or RAS mutations; exclude mixed NSCLC\u002FSCLC histology.\n* Phase II Cohort 2 (Endometrial Cancer):Exclude uterine carcinosarcoma, endometrial leiomyosarcoma, or endometrial stromal sarcoma.\n* Phase II Cohort 3 (Other Solid Tumors):Exclude KRAS\u002FNRAS\u002FBRAF mutations or MSI-H status.\n* Phase II Cohort 4 (Ovarian Cancer) \\& Ib Phase TCC1727 + Olaparib Tablets: Exclude prior myelodysplastic syndrome or acute myeloid leukemia.",{"count":177,"type":20},266,[55,23],"This is a Phase Ib\u002FII clinical study. The Phase Ib dose-escalation study aims to evaluate and determine the recommended Phase II dose (RP2D) of TCC1727 in combination with benmelstobart \u002Folaparib \u002Ftopotecanfor patients with advanced solid tumors.\n\nThe Phase II expansion study will assess the efficacy and safety of TCC1727 combined with benmelstobart \u002Folaparib\u002Ftopotecanin selected advanced solid tumor indications.\n\nThe study pre-specifies three treatment combinations, with Combination 1 (TCC1727 + benmelstobart) being prioritized for initial evaluation. The decision to proceed with Combination 2 and Combination 3will be based on clinical data from Combination 1.",[181,182,183,184,26],"Solid Cancers","NSCLC (Advanced Non-small Cell Lung Cancer)","Gastric (Stomach) Cancer","Endometrial Cancer",[186,187],"Ataxia Telangiectasia and Rad3-related protein inhibitor","Advanced solid tumor","2026-01-19",{"date":190,"type":35},"2026-01-28",{"date":192,"type":35},"2025-12-03",{"date":194,"type":20},"2029-06-30",{"name":196,"class":42},"Beijing Tide Pharmaceutical Co., Ltd",3,{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":21,"phases":208,"briefSummary":209,"conditions":210,"keywords":215,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":137},"100541660","phase-1-study-to-evaluate-lb-lr1109-administered-alone-for-the-treatment-of-solid-tumor-and-in-combination-with-atezolizumab-for-the-treatment-of-nsclc-100541660","NCT06332755","Study to Evaluate LB-LR1109, Administered Alone for the Treatment of Solid Tumor and in Combination With Atezolizumab for the Treatment of NSCLC","A Phase 1a\u002F1b, First-in-Human, Open-Label, Multi-Center, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LB-LR1109, When Administered Alone for the Treatment of Advanced or Metastatic Solid Tumors, and in Combination With Atezolizumab for the Treatment of Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)","LB-LR1109","Key Inclusion Criteria:\n\n1. Age ≥18 years old at the time of signing the ICF.\n2. (Phase 1a only) Participants must have 1 of the following histologically confirmed advanced or metastatic solid tumors with measurable or non-measurable disease as determined by RECIST v1.1,\n\n   \\- NSCLC, HNSCC, RCC, urothelial carcinoma, or malignant melanoma.\n3. (Phase 1a only) Participants who have metastatic disease which has progressed during or after approved standard therapies or are intolerant to approved therapies, or for which the participant refuses or is ineligible for standard therapy.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.\n5. Life expectancy ≥12 weeks.\n6. Participants with adequate organ function\n7. No potential for childbearing or agree to use adequate contraception\n8. Ability to understand the study purpose and procedures and have the willingness to sign a written informed consent document.\n9. (Phase 1b only ) Must have histologically confirmed advanced or metastatic NSCLC without actionable genomic alteration that have approved therapies in the location where the participant's live and with measurable disease as determined by RECIST v1.1\n\nKey Exclusion Criteria:\n\n1. Clinically significant cardiac disease or cardiac failure.\n2. Untreated or unstable brain or central nervous system (CNS) metastases or Leptomeningeal disease\n3. Participants with any concurrent active malignancies\n4. Has received prior therapy targeting LILRB or immunoglobulin-like transcript pathway.\n5. History of life-threatening toxicity related to prior immune therapy\n6. Has not recovered to ≤ Grade 1 or baseline from AEs and\u002For complications from prior surgical intervention or any anti-cancer treatment before starting study treatment\n7. Participants must not have an active, known, or suspected autoimmune disease.\n8. Evidence of active infection requiring IV antibiotic treatment ≤7 days prior to initiation of study treatment therapy (does not apply to viral infections that are presumed to be associated with the underlying tumor type required for study entry).\n9. Pregnant or lactating or expecting to conceive a child during the study or within 6 months after the last dose of study intervention.\n10. Any condition that would, in the Investigator's judgment, interfere with full participation in the study, including administration of study intervention and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n11. (Phase 1b only) Participants who were previously exposed to atezolizumab",{"count":207,"type":20},76,[55],"This is a Phase 1a\u002F1b, first-in-human (FIH), multi-center, open-label, non-randomized, dose escalation study, designed to determine the Maximum tolerated dose(MTD)\u002FRecommended Phase 2 dose (RP2D) and to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, pharmacodynamics of LB-LR1109 as monotherapy in participants with advanced and\u002For metastatic non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), renal cell carcinoma (RCC), urothelial carcinoma, or malignant melanoma and no available standard of care treatment options, and as combination therapy with atezolizumab in participants with advanced and\u002For metastatic NSCLC.",[211,212,213,214,26],"Non-small Cell Lung Cancer(NSCLC)","Head and Neck Squamous Cell Carcinoma(HNSCC)","Renal Cell Carcinoma(RCC)","Urothelial Carcinoma",[66],"2025-11-19",{"date":218,"type":35},"2025-11-24",{"date":220,"type":35},"2024-06-05",{"date":222,"type":20},"2028-03",{"name":224,"class":42},"LG Chem",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":21,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":137},"100531969","fmt-in-checkpoint-inhibitor-mediated-diarrhea-and-colitis-100531969","NCT06206707","FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis","Faecal Microbiota Transplantation for Immune Checkpoint Inhibitor-mediated Diarrhea\u002FColitis: a Randomised, Double-blind Pilot Efficacy and Safety Study","Immunobiome","Inclusion Criteria:\n\n1. Age 18 years or above.\n2. Histologically proven diagnosis of malignant melanoma and\u002For kidney cancer.\n3. Treatment with any immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Durvalumab, Avelumab, Ipilimumab), alone or in combination, within the last 8 weeks.\n4. Grade 2 or higher CTCAE diarrhea, of which at least 3 stools are Bristol chart score 6-7.\n5. Negative PCR for enteric pathogens including C. difficile, after the onset of diarrhea.\n6. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosed bacterial infection requiring antibiotic treatment at inclusion.\n2. Pregnancy or breastfeeding. Pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hCG) urine test.\n3. Primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease.\n4. Unable to ingest capsules.\n5. Unable to understand written or oral patient information.",{"count":234,"type":20},20,[117],"The goal of this clinical trial is to determine the outcome of patients with immune checkpoint inhibitor-mediated diarrhea\u002Fcolitis (IMC) treated with faecal microbiota transplantation (FMT) in a randomised, placebo-controlled trial.\n\nThe aim of the present study is to assess the feasibility, pilot efficacy, and safety of FMT for patients with IMC.\n\nParticipants will be treated two times with capsule FMT or placebo capsules in a 1:1 ratio. The intervention treatment will be an add-on to the patients' standard treatment for IMC.\n\nResearchers will compare the FMT-treated group to the placebo-treated group to see if FMT promotes remission of IMC.",[238,239,26,240],"Diarrhea","Colitis","Kidney Cancer","2025-11-14",{"date":243,"type":35},"2025-11-17",{"date":245,"type":35},"2024-01-23",{"date":247,"type":20},"2026-10-31",{"name":249,"class":136},"University of Aarhus",{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":21,"phases":259,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":137},"100201394","phase-1-modified-vaccine-for-high-risk-or-low-residual-melanoma-patients-100201394","NCT01898039","Modified Vaccine for High Risk or Low Residual Melanoma Patients","Allogeneic Vaccine Modified to Express HLA A2\u002F4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients - Phase I\u002FII Study.","Inclusion Criteria:\n\n1. Patients included in this protocol must carry one or more of the following tissue typing alleles: HLA-A2, -A24, -A33, -B35, -B49, -CW04\u002F12(04\u002F08). We estimate that 50% of melanoma patients will be eligible.\n2. Cutaneous malignant melanoma AJCC stage IIb (\\>4 mm) or IIc (ulcerated melanoma \\>4mm).\n3. Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post-surgical removal of lymph nodes.\n4. Metastatic melanoma AJCC stage IV, completely resected.\n5. Non-resectable metastatic melanoma of low burden disease and normal LDH who have undergone at least two treatment lines, including chemotherapy (DTIC, temodal, taxanes, platinum compounds), anti-CTLA-4 (ipilimumab) and B-RAF inhibitor if harboring the V600E BRAF mutation in their tumor.\n6. Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.\n7. Melanoma can be of either mutant or wild-type B-RAF.\n8. Karnofsky performance status \\> 80 (Normal activity with effort).\n9. No active cardio-respiratory disease.\n10. Not pregnant or nursing. Women must take contraceptives during the treatment period.Hematocrit \\>25% and WBC \\>3000.\n11. Informed consent of the patient.\n\nExclusion Criteria:\n\n1. Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.\n2. Active brain metastases requiring corticosteroids.\n3. Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).\n4. Active serious infection.\n5. Allergy to penicillin.\n6. Patient's will to withdraw from the study at any stage.\n7. HIV and chronic hepatitis B and C carrier",{"count":258,"type":20},50,[55,23],"This study is designed for patients who had malignant melanoma and, following tumor removal, are now free of disease, or have only very minor residual disease, and are at a very high risk of disease recurrence. These patients will be treated with the A2\u002F4-1BBL melanoma vaccine, a compatible melanoma cell line that has been engineered to express a molecule termed 4-1BBL, which enhances the chances of the cell line to be recognized by the patient's immune system, and to induce its stimulation. The hypothesis that drives the study states that the immune response against the cell line will also be effective against the residual tumor that may still be present in the body.",[26],[263,264,265,266,267],"malignant melanoma","vaccine","cell line","high risk","residual disease","2025-09-29",{"date":270,"type":35},"2025-10-02",{"date":272,"type":4},"2013-05",{"date":274,"type":20},"2027-04",{"name":276,"class":136},"Hadassah Medical Organization",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":21,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":137},"100532190","phase-1-amt-253-in-patients-with-advanced-solid-tumours-100532190","NCT06209580","AMT-253 in Patients With Advanced Solid Tumours","Phase I\u002FII Study of AMT-253 in Patients With Unresectable or Metastatic Malignant Melanoma and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Patients must be willing and able to understand and sign the ICF, and to adhere to the study visit schedule and other protocol requirements.\n* 2\\. Patients with histologically confirmed melanoma or other advanced solid tumor.\n* 3\\. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease (PD) during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.\n* 4\\. Patients must have at least one measurable lesion as per RECIST version 1.1.\n* 5\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* 6\\. Life expectancy ≥ 3 months.\n* 7\\. Patients must have adequate organ function\n* 8\\. Women of child bearing potential (WCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months must agree to use two effective contraceptive methods while on study treatment and for at least twelve weeks after the last dose of the IMP.\n* 9\\. WCBP must have a negative serum pregnancy test within 7 days prior to first dose of the IMP.\n* 10\\. Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least twelve weeks after the last dose of the IMP.\n* 11\\. Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.\n* 12\\. Availability of tumor tissue sample at screening.\n\nExclusion Criteria:\n\n* 1\\. Prior treatment with any agent that has the same target.\n* 2\\. Central nervous system (CNS) metastasis.\n* 3\\. Active or chronic skin disorder requiring systemic therapy.\n* 4\\. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.\n* 5\\. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \\>1.\n* 6\\. Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.\n* 7\\. Major surgery within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention.\n* 8\\. Significant cardiac disease, such as recent myocardial infarction or acute coronary syndromes, congestive heart failure， uncontrolled hypertension, uncontrolled cardiac arrhythmias.\n* 9\\. History of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within six months prior to first dose of the IMP.\n* 10\\. Acute and\u002For clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).\n* 11\\. Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.",{"count":285,"type":20},96,[55,23],"This is a non-randomized, open-label, multicenter Phase I\u002FII study of AMT-253 in patients with Unresectable or Metastatic Malignant Melanoma and other Advanced Solid Tumors. This study include phase I dose escalation and phase II dose expansion.",[26,289],"Advanced Solid Tumors","2025-08-28",{"date":292,"type":35},"2025-09-05",{"date":294,"type":35},"2024-01-31",{"date":296,"type":20},"2026-12-31",{"name":298,"class":42},"Multitude Therapeutics Inc.",{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":306,"minAge":17,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":21,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":137},"100559190","phase-2-preoperative-planning-with-psma-pet-in-melanoma-surgery-trial-100559190","NCT06560905","Preoperative Planning With PSMA-PET in Melanoma Surgery Trial","PPPIMS","Inclusion Criteria:\n\n* Males ≥18 years of age\n* Biopsy proven first and recurrent metastatic melanoma with palpable nodal disease who have undergone a staging FDG PET-CT scan as part of routine clinical care and are scheduled for surgery for resection of the primary site\n\nExclusion Criteria:\n\n* Patients unable to give voluntary written informed consent to participate in this study\n* Patients not willing to complete all the study assessments\n* Patients who are females\n* Patients who are taking androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists.\n* Patients who have or have previously been diagnosed with prostate cancer\n* Patients who have had Lu-177 PSMA therapy or barium studies within a period of 10 days prior to undergoing PSMA PET-CT scanning\n* Patients not fluent in English","MALE",{"count":308,"type":20},16,[23],"This is a non-randomised, single-centre Phase 2 study, investigating whether the diagnostic biomarker, prostate-specific membrane antigen (PSMA), can detect melanoma metastases using PSMA PET\u002F CT.",[26],"2025-06-26",{"date":314,"type":35},"2025-07-01",{"date":316,"type":35},"2025-03-11",{"date":318,"type":20},"2025-12-31",{"name":320,"class":136},"Royal Marsden NHS Foundation Trust",{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":330,"phases":4,"briefSummary":331,"conditions":332,"keywords":334,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":197},"100591462","video-tumorboard-plus-100591462","NCT06980740","Video-Tumorboard PLUS","vTB+","Inclusion Criteria:\n\n* The study includes adult, external patients who, according to the certification requirements of the German Cancer Society, should be presented to the CCCs in a tumor board .\n\nInclusion criteria for patients:\n\n* Minimum age 18 years\n* Consent to participate in the study (signing of patient consent) should be presented in vTB+ according to the doctor, based on the disease\u002Fdiagnosis, especially in the case of:\n\n  * Malignant melanoma from stage IIB\n  * Malignant melanoma and stage shift\u002Frecurrence o Extracutaneous melanoma o Cutaneous lymphoma from stage Ib o Problem cases with malignant, epithelial tumors (BCC, SCC) with interdisciplinary issues, e.g. complicated localization, extension\u002F infiltration (e.g. Ulcus rodens, Ulcus terebrans), metastasized tumors, immunosuppressed patients o all rare malignant skin tumors (including Merkel cell carcinoma, DFSP, MFH, leiomyosarcoma, S., Kaposi's sarcoma, angiosarcoma), regardless of stage o severe side effects from drug-based tumor therapy • is an external patient: An external patient is someone who receives tumor therapy exclusively or in co-treatment in the branch or in an external clinic (in distinction to patients without prior treatment for initial presentation at the CCC) . This also applies to patients who are only seen once at the vTB.\n\nIn this case, revenue\u002Fcost aspects and the DKG requirement are ignored. This means that so-called external patients can also be treated at the center, including initiation of therapy. The decisive factor is the presentation of the external patient (personal presentation of the external patients is not mandatory) and that external co-treaters are consistently informed and involved.\n\nInclusion criteria for external doctors:\n\n* has a medical license\n* has dermatological patients who are eligible to be presented in the vTB+\n\nExclusion Criteria:\n\nPatients will be excluded from the study if they meet the following criteria:\n\n* Linguistic or other limitations (such as dementia) that prevent independent consent to the privacy policy.\n* No consent to participate in the study (patient consent) or withdrawal of consent during the course of the study In addition, external physicians will be excluded from the study if no joint cooperation agreement can be negotiated and signed.",{"count":329,"type":20},300,"OBSERVATIONAL","In weekly expert meetings for oncological diagnostics and therapy, known as tumor boards, individual therapy recommendations are developed for cancer patients. By further developing and optimizing the CCCs' video tumor boards, initially using skin cancer as an example, we want to ensure that more patients can benefit from the expertise of several specialist disciplines and innovations - regardless of where they live.",[26,333],"Telemedicine",[26,333],"2025-05-16",{"date":337,"type":35},"2025-05-20",{"date":339,"type":35},"2025-05-01",{"date":341,"type":20},"2027-05-31",{"name":343,"class":136},"University Hospital Muenster",{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":21,"phases":353,"briefSummary":354,"conditions":355,"keywords":364,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":375,"locationsCount":137},"100450377","phase-1-rapa-201-therapy-of-solid-tumors-100450377","NCT05144698","RAPA-201 Therapy of Solid Tumors","Phase I\u002FII Trial of Autologous Rapamycin-Resistant Th1\u002FTc1 (RAPA-201) Cell Therapy of PD-(L)1 Resistant Solid Tumors","Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n3. Advanced metastatic, recurrent, and unresectable solid tumor that has relapsed after ≥ one prior line of therapy.\n4. Subject must have received prior therapy with disease-specific regimens that have been established to convey a clinical benefit. Alternatively, subject must have been offered such regimens and provided written documentation of refusal to receive such regimens.\n5. Subject with solid tumors with genetic alterations and mutations (including but not limited to BRAF, BRCA, EGFR mutations, and ALK translocations) must have either received targeted therapy for such conditions or provided written documentation of refusal to receive such regimens.\n6. Exposure to an anti-PD-(L)1 monoclonal antibody therapeutic in the most recent line of prior therapy.\n7. 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 anti-PD-(L)1-containing therapy.\n8. Solid tumor disease types that are eligible for enrollment consist of:\n\n   1. head and neck cancer (squamous cell carcinoma of oral cavity, larynx, nasopharynx, and other sites);\n   2. malignant melanoma;\n   3. small cell carcinoma, thoracic and extra-thoracic; and,\n   4. non-small cell lung cancer.\n9. Presence of measurable disease to permit monitoring by RECISTv1.1 Criteria.\n10. 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 ≥ 300 cells\u002FμL.\n11. Patients must be ≥ two weeks from last solid tumor cancer chemotherapy, major surgery, radiation therapy and\u002For participation in investigational trials.\n12. Patients must have recovered from clinical toxicities (resolution of CTCAE (v5) toxicity to a value of ≤ 2).\n13. Ejection fraction (EF) by MUGA or 2-D echocardiogram within institution normal limits, with an EF level of ≥ 40%.\n14. Calculated creatinine clearance of ≥ 60 mL\u002Fmin\u002F1.73 m\\^2.\n15. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x upper limit of normal.\n16. ANC (Absolute neutrophil count) of ≥ 1500 cells\u002FμL.\n17. Platelet count ≥ 100,000 cells\u002FμL.\n18. Hemoglobin count ≥ 8 grams\u002FμL.\n19. Bilirubin ≤ 1.5 mg\u002FdL (except if due to Gilbert's disease).\n20. Corrected DLCO ≥ 50% (Pulmonary Function Test)\n21. No history of abnormal bleeding tendency (as defined by any inherited coagulation defect, or history of internal bleeding).\n22. 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 \\\u003C 4 months.\n3. Seropositivity for HIV, hepatitis B, or hepatitis C, unless such conditions are in stable condition using adequate treatment.\n4. Uncontrolled hypertension.\n5. History of cerebrovascular accident within 6 months of enrollment.\n6. Myocardial infarction within 6 months prior to 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. Patients of childbearing age, 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.",{"count":352,"type":20},37,[55,23],"The therapy of solid tumors has been revolutionized by immune therapy, in particular, approaches that activate immune T cells in a polyclonal manner through blockade of checkpoint pathways such as PD-1 by administration of monoclonal antibodies. In this study, the investigators will evaluate the adoptive transfer of RAPA-201 cells, which are checkpoint-deficient polyclonal T cells that represent an analogous yet distinct immune therapy treatment platform for solid tumors. The administration of polyclonal, metabolically-fit RAPA-201 cells is a novel adoptive T cell therapy approach that is suitable for regenerative medicine efforts.\n\nRAPA-201 is a novel immunotherapy product consisting of reprogrammed autologous CD4+ and CD8+ T cells of Th1\u002FTc1 cytokine phenotype. RAPA-201, which have acquired resistance to the mTOR inhibitor temsirolimus, are manufactured ex vivo from peripheral blood mononuclear cells collected from solid tumor patients using a steady-state apheresis. The novel RAPA-201 manufacturing platform, which incorporates both an mTOR inhibitor (temsirolimus) and an anti-cancer Th1\u002FTc1 polarizing agent (IFN-alpha) generates polyclonal T cells with five key characteristics:\n\n1. Th1\u002FTc1: polarization to anti-cancer Th1 and Tc1 subsets, with commensurate down-regulation of immune suppressive Th2 and regulatory T (TREG) subsets;\n2. T Central Memory: expression of a T central memory (TCM) phenotype, which promotes T cell engraftment and persistence for prolonged anti-tumor effects;\n3. Rapamycin-Resistance: acquisition of rapamycin-resistance, which translates into a multi-faceted anti-apoptotic phenotype that improves T cell fitness in the stringent conditions of the tumor microenvironment;\n4. T Cell Quiescence: reduced T cell activation, as evidence by reduced expression of the IL-2 receptor CD25, which reduces T cell-mediated cytokine toxicities such as cytokine-release syndrome (CRS) that limit other forms of T cell therapy; and\n5. Reduced Checkpoints: multiple checkpoint inhibitory receptors are markedly reduced on RAPA-201 cells (including but not limited to PD-1, CTLA4, TIM-3, LAG3, and LAIR1), which increases T cell immunity in the checkpoint-replete, immune suppressive tumor microenvironment.\n\nThis is a non-randomized, open label, multi-site, phase I\u002FII trial of outpatient RAPA-201 immune T cell therapy in patients with advanced metastatic, recurrent, and unresectable solid tumors that have recurred or relapsed after prior immune therapy. Patients must have tumor relapse after at least one prior line of therapy and must have refractory status to the most recent regimen, which must include an anti-PD-(L)1 monoclonal antibody. Furthermore, accrual focuses upon solid tumor disease types potentially amenable to standard-of-care salvage chemotherapy consisting of the carboplatin + paclitaxel (CP) regimen that will be utilized for host conditioning prior to RAPA-201 therapy. Importantly, carboplatin and paclitaxel are \"immunogenic\" chemotherapy agents whereby the resultant cancer cell death mechanism is favorable for generation of anti-tumor immune T cell responses. Thus, the CP regimen that this protocol incorporates is intended to directly control tumor progression and indirectly promote anti-tumor T cell immunity.\n\nProtocol therapy consists of six cycles of standard-of-care chemotherapy (carboplatin + paclitaxel (CP) regimen) administered in the outpatient setting every 28 days (chemotherapy administered on cycles day 1, 8, and 15). RAPA-201 cells will be administered at a target flat dose of 400 X 10\\^6 cells per infusion on day 3 of cycles 2 through 6.\n\nIn the original protocol design, a sample size of up to 22 patients was selected to determine whether RAPA-201 therapy, when used in combination with the CP regimen, represents an active regimen in solid tumors that are resistant to anti-PD(L)-1 checkpoint inhibitor therapy, as defined by a response rate (≥ PR) consistent with a rate of 35%. The first stage of protocol accrual consisted of n=10 patients; to advance to the second protocol accrual stage (accrual of an additional n=12 patients), RAPA-201 therapy must result in a tumor response (≥ PR) in at least 2 out of the 10 initial patients. As described below in the detailed description, this original protocol implementation demonstrated that RAPA-201 represented an active treatment regimen for solid tumor patients, and as such, the protocol was expanded to evaluate the combination of RAPA-201 therapy followed by anti-PD1 maintenance therapy.",[356,357,358,359,360,361,362,26,363],"Solid Tumor","Small Cell and Non-small Cell Lung Cancer","Head and Neck Cancer","Squamous Cell Carcinoma of Oral Cavity","Squamous Cell Carcinoma of Larynx","Squamous Cell Carcinoma of Nasopharynx","Squamous Cell Carcinoma of Other Specified Sites of Skin","Esophageal Squamous Cell Carcinoma",[365,366,367,368,156],"Refractory to Checkpoint Therapy","PD-1","PD-L1","Adoptive T cell therapy","2025-05-09",{"date":371,"type":35},"2025-05-14",{"date":373,"type":35},"2021-08-01",{"date":296,"type":20},{"name":168,"class":42},{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":21,"phases":386,"briefSummary":387,"conditions":388,"keywords":392,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":4},"100591099","phase-2-immune-pet-and-proteomics-for-the-assessment-of-response-to-spatially-fractionated-or-palliative-radiotherapy-with-or-without-immunotherapy-100591099","NCT06976021","Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy","Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy Ocena Efektu immunomodulującego Radioterapii Paliatywnej, w Tym Radioterapii z Przestrzennym zróżnicowaniem Dawki, Podanej Samodzielnie Lub z immunoterapią, u Chorych którzy Wyczerpali możliwość Leczenia Systemowego i Radioterapii Radykalnej, Przy Wykorzystaniu Immuno-PET i badań Proteomicznych","INTROSPECTION","Inclusion Criteria:\n\n1. Pathologically confirmed diagnosis of clear cell renal cell carcinoma, melanoma, cervical cancer, endometrial cancer or triple negative breast cancer.\n2. Patients nnot eligible for radical treatment with radiotherapy (including stereotactic radiotherapy of the tumor in the potential planned area of irradiation in the study), chemotherapy and palliative immunotherapy in accordance with applicable national standards but who qualify for palliative radiation treatment\n3. General condition according to Karnofsky scale: 60-100\n4. Patients with tumor (index lesion) larger than 5 cm in size that can be irradiated with either SHORT or SFRT technique (presence of other tumors that may be independently treated locally is not an exclusion criterion)\n5. The tumor may be assessed using iRECIST\n6. Age over 18 years\n7. Granted written, informed consent to participate in the research experiment\n8. No contraindications to treatment with Pembrolizumab (according to the information provided in the product characteristics).\n9. Expected survival time over 6 months.\n\nExclusion criteria\n\n1. Lack of consent to participate in the experiment\n2. Contraindications to Pembrolizumab according to the product characteristics\n3. Pregnancy and lactation\n4. Inability of the patient to cooperate, including claustrophobia that prevents imaging tests from being performed as planned.\n5. Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout treatment and for 5 months after its completion.\n6. Condition after organ transplantation",{"count":385,"type":20},60,[23],"The aim of the study is to evaluate the response to four schemes of treatment with novel diagnostic tools - Immuno-PET and proteomics as well as standard imaging (magnetic resonsonce imaging and computed tomography). Two fractionation schedules of radiotherapy will be used. The first will be a common standard of palliative irradiation - 20 Gy delivered in five fractions of 4 Gy (SHORT). The other is called Spatially Fractionated Radiotherapy (SFRT). SFRT is delivered in one fraction of 20 Gy but the dose is diversified inside the tumor to produce areas of high and low doses distributed alternately. This kind of irradiation may be able to stimulate immune response and improve the efficiency of immunotherapy. A drug belonging to the class of immunotherapeutic agents - Pembrolizumab will be added to the treatment scheme in two arms of the study to check that assumption. The response of the target tumor will be evaluated with PET study using Pembrolizumab labeled with zirconium-89 which will show the spatial distribution of immune receptors within the target tumor and other involved sites if there are any. The examination will be repeated after the treatment to evaluate changes in distribution of the immune receptors necessary for the drug to work. Additionally, the researchers will repeatedly test the presence and concentration of a wide panel of proteins in blood to evaluate response to the treatment more precisely.",[93,389,390,26,391],"Uterine Cervical Cancer","Uterine Corpus Cancer","Clear Cell Renal Cell Carcinoma",[393,394,395,396,397],"spatially fractionated radiotherapy","immunotherapy","immuno-PET","proteomics","signaling pathways","2025-05-08",{"date":335,"type":35},{"date":401,"type":20},"2025-06",{"date":403,"type":20},"2029-12",{"name":405,"class":136},"Maria Sklodowska-Curie National Research Institute of Oncology",{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":330,"phases":4,"briefSummary":416,"conditions":417,"keywords":418,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":430},"100272594","follow-up-of-a-national-cohort-of-melanoma-resectable-stage-ii-stage-iii-or-iv-patients-or-unresectable-primary-100272594","NCT02828202","Follow-up of a National Cohort of Melanoma Resectable Stage II, Stage III or IV Patients or Unresectable Primary","Constitution of a National Cohort of Patients With Metastatic Melanoma Resectable Stage II or Stage III or IV or Unresectable Primary With the Objective of Setting up Epidemiological Monitoring and Clinico-biological Database, MELBASE","MelBase","1. Cohort Patients with Resectable stage II or III\n\n   Inclusion Criteria:\n\n   Patients diagnosed with resectable stage IIA\u002FIIB\u002FIIC or III melanoma, confirmed by histological exam.\n\n   Naïve of systemic treatment for resectable stage II or III. Whose metastatic tumoral material can be collected by the Biological Resource Centers (optional criteria).\n\n   Aged ≥ 18 years. Consenting to participate (signed informed consent).\n\n   Exclusion Criteria:\n\n   Patients refusal. Choroid melanoma. Resectable stage 1 melanoma. Stage 4, unresectable primitive or unresectable stage 3 melanoma. Patients under guardianship and under trusteeship.\n2. Cohort patients with Unresectable stage III or stage IV (resectable or not) or unresectable primary:\n\nInclusion Criteria:\n\nPatients diagnosed with an advanced melanoma, confirmed by histological exam. Unresectable primitive or unresectable stage III or stage IV (resectable or not) melanoma ; or patients treated by neoadjuvant treatment (exceptional) Naïve of systemic treatment for unresectable primitive or unresectable stage III or stage IV (resectable or not) melanoma, except adjuvant treatment.\n\nWhose metastatic tumoral material can be collected by the Biological Resource Centers (optional criteria).\n\nAged ≥ 18 years. Consenting to participate (signed informed consent).\n\nExclusion Criteria:\n\nResectable stage 1, 2 or 3 melanoma. Patients refusal. Choroid melanoma. Patients under guardianship and under trusteeship.",{"count":415,"type":20},6000,"Prevention of melanoma can be efficient but mortality remains unchanged and 15 to 20% of patients still die from melanoma. Indeed metastatic melanoma is a heterogeneous highly and multiple mutations driven cancer. Significant survival benefit was demonstrated since 2011 with anti-CTLA4 +\u002F- programmed death-1 (anti PD1) antibodies, B-Raf proto-oncogene, serine\u002Fthreonine kinase (BRAF) and MAP-ERK kinase (MEK) inhibitors. Future improvement of advanced melanoma prognosis will rely on clinico-epidemiological studies and on biological studies to validate and identify new prognostic and predictive factors based on clinico-epidemiological and histological data, genomic host and tumor alterations, tumor microenvironment characteristics, individual immunological profile and functional imaging. In the context of marketing of costly innovative molecules, prospective collection of economic data on treatment and toxicity are required. Large biobanks collecting data from cohorts of advanced melanoma are mandatory for such projects.\n\nMELBASE is a French prospective national cohort enrolling advanced melanoma patients whose objectives are to :\n\n* provide an annual instrument panel with descriptive and correlative analysis of advanced melanoma patients in France including epidemiological, clinical, biological and economic characteristics\n* validate and identify new clinical, epidemiological, and biological prognostic factors such as genomic host and tumor alterations, tumor microenvironment characteristics, individual immunological profile in advanced melanoma\n* evaluate the risk-benefit, quality of life, the management cost of patients treated with validated and future treatments. The project also aims to define predictive biomarkers of response and toxicity including pharmacogenetics and tumor genetics alterations, tumor microenvironment characteristics, individual immunological profile.\n\nPatients with resectable stage II or III will be enrolled since June 2023 with a 10 years follow-up.\n\nPatients with unresectable stage III or IV (resectable or not) or unresectable primary melanoma will be enrolled prospectively since March 2013 with a 10 years follow-up (up to 6000 patients) from 27 French centers.",[26],[69,419,420],"Skin","Biobank","2025-02-10",{"date":423,"type":35},"2025-02-11",{"date":425,"type":35},"2013-02",{"date":427,"type":20},"2026-03",{"name":429,"class":136},"Assistance Publique - Hôpitaux de Paris",27,{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":437,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":21,"phases":441,"briefSummary":442,"conditions":443,"keywords":444,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":234},"100294708","a-randomized-trial-to-assess-the-role-of-imaging-during-follow-up-after-radical-surgery-of-high-risk-melanoma-100294708","NCT03116412","A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma","A Prospective Randomized Multicenter Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of Stage IIb-c and III Cutaneous Malignant Melanoma","TRIM","Inclusion Criteria:\n\n* At least 18 years of age.\n* Radical surgery for Cutaneous Malignant Melanoma (CMM) stage IIb-c and III.\n* Sufficient renal function for i.v. contrast scannings.\n\nExclusion Criteria:\n\n* The patient is assessed as unfit to receive treatment in the case of recurrence.\n* Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease, terminal multiple sclerosis, liver cirrhosis).\n* Inability to provide informed consent or refusal to do so.\n* Inability to comply with the control or intense follow-up program.\n* Participation in other clinical trials interfering with the control-program.\n* Existing or previous malignancies within the past 5 years (except for in situ breast and cervical cancer, melanoma in situ and non-melanoma skin cancer).\n* Pregnancy or currently planned pregnancy.",{"count":440,"type":20},1300,[117],"It is not known whether radiological assessments during follow up after surgery for high risk melanoma improve survival. Since radiological examinations are resource demanding, could inflict worry and cause irradiation exposure it is an important question to address. With the introduction of effective medical treatments for malignant melanoma patients, there is a tendency to introduce radiological assessments despite the lack of evidence.",[26],[445,446,447,448],"Malignant melanoma","Follow up","Radiology","Survival","2024-12-11",{"date":451,"type":35},"2024-12-16",{"date":453,"type":35},"2017-06-08",{"date":455,"type":20},"2028-12-31",{"name":457,"class":136},"Uppsala University",{"id":459,"slug":460,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":11,"sex":466,"minAge":467,"maxAge":468,"enrollmentInfo":469,"targetDuration":4,"studyType":21,"phases":470,"briefSummary":471,"conditions":472,"keywords":474,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":137},"100476049","carbon-ion-radiation-therapy-in-the-treatment-of-mucous-melanomas-of-the-female-lower-genital-tract-100476049","NCT05478876","Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract","CNAO 40-2020 C CYCLE \"Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract\" \"Radioterapia Con Ioni Carbonio Per il Trattamento Dei Melanomi Mucosi Ginecologici\"","CYCLE","Inclusion Criteria:\n\n* Histological diagnosis\n* Absence of skin extension\n* N + (only if confined to the groin and pelvis)\n* Age between 20-80 years\n* ECOG 0-2\n* No evidence of metastasis\n* At least 5 mm away with rectum and bladder wall\n* No previous RT\n* Written informed consent\n* Patient's ability to understand the characteristics and consequences of the clinical trial\n* Molecular characterization\u002F mutational state\n* Disease staging (baseline exams)\n\nExclusion Criteria:\n\n* Hip prosthesis, or metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan\n* Psychic or other disorders that may prevent informed consent\n* Previous invasive tumor unless patient has been disease free for at least 3 years\n* Contraindication to MRI\n* Pregnancy or breastfeeding in progress","FEMALE","20 Years","80 Years",{"count":105,"type":20},[117],"The present monocentric prospective phase 2 study aims to reproduce the results obtained at NIRS thus offering the possibility of obtaining a promising rate of progression-free survival (PFS) and local control (LC) in patients diagnosed with mucosal melanoma of lower genital tract. Systemic treatment with immunotherapy is not the subject of this study but is allowed both in the neoadjuvant and sequential regimens.\n\nMelanomas have always been considered poorly radiosensitive. It is now accepted that high LET (Linear Energy Transfer) particle beams, such as carbon ions, can offer a biological advantage, compared to photons treatment, in radio-resistant neoplasms treatment, thanks to their higher biological efficacy (RBE) against tumours with a low α\u002F ß ratio. In addition, carbon ions have the physical advantage of an inverted depth deposition profile compared to photons, allowing then a steep dose gradients that ensure increased sparing of adjacent healthy organs at risk (OARs).",[26,473],"Gynecologic Cancer",[475],"hadrontherapy, gynecological melanoma","2024-08-20",{"date":478,"type":35},"2024-08-21",{"date":480,"type":35},"2020-09-03",{"date":482,"type":20},"2027-09",{"name":484,"class":136},"CNAO National Center of Oncological Hadrontherapy",{"id":486,"slug":487,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":491,"enrollmentInfo":492,"targetDuration":4,"studyType":21,"phases":494,"briefSummary":495,"conditions":496,"keywords":4,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":4},"100558642","a-single-arm-multicenter-clinical-study-of-fruquintinib-combined-with-cadonilimab-injection-and-temozolomide-in-second-line-and-subsequent-treatment-of-advanced-melanoma-100558642","NCT06553781","A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Cadonilimab Injection and Temozolomide in Second-line and Subsequent Treatment of Advanced Melanoma","Inclusion Criteria:\n\n1. Have fully understood the study and voluntarily signed the informed consent;\n2. Age 18-75 years old (including 18 and 75 years old), gender is not limited;\n3. Stage IV melanoma determined by pathology or cytology;\n4. Patients with advanced malignant melanoma who have failed previous first-line therapy (cutaneous melanoma patients are excluded) and patients with BRAF V600 mutations need to be admitted after targeted therapy.\n5. 4 weeks or more since the last systematic treatment before enrollment;\n6. ECOG physical condition 0-1 score;\n7. Expected survival ≥3 months;\n8. Must have at least one measurable lesion (RECIST version 1.1);\n9. The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors within 14 days prior to enrollment is not allowed) :\n\n   Absolute neutrophil count ≥1.5×109\u002FL;\n\n   Platelet ≥100×109\u002FL;\n\n   Hemoglobin ≥90g\u002FL;\n\n   Total bilirubin \\\u003C 1.5 ULN;\n\n   ALT and\u002For AST \\\u003C 1.5 times ULN;\n\n   Serum creatinine \\\u003C 1.5 ULN;\n\n   endogenous creatinine clearance ≥50ml\u002Fmin;\n10. Women of childbearing age need to take effective contraceptive measures;\n11. Good compliance, cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Failure to comply with the study protocol or study procedure;\n2. Patients with active brain metastases;\n3. Received organ surgery 6 weeks before enrollment;\n4. Had other malignant tumors within 5 years prior to admission, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;\n5. Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, in the 6 months prior to enrollment;\n6. Subjects who are allergic to the investigational drug or any of its adjuncts;\n7. Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment;\n8. International Standardized Ratio (INR) \\>1.5 or partially activated prothrombin time (APTT) \\>1.5×ULN;\n9. The investigator identified clinically significant electrolyte abnormalities;\n10. Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg;\n11. Poorly controlled diabetes mellitus was present before enrollment (fasting glucose concentration ≥CTCAE level 2 after formal treatment);\n12. Had any disease or condition affecting drug absorption before enrollment, or the patient could not take the drug orally;\n13. Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresectable tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;\n14. Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding within 3 months \\> 30 mL, hematemesis, stool, stool blood), hemoptysis (within 4 weeks \\>; 5 mL of fresh blood) or had a thromboembolic event (including stroke events and\u002For transient ischemic attacks) within 12 months;\n15. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe\u002Funstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure \\>Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) \\\u003C 50%;\n16. Active or uncontrolled severe infection (≥CTCAE v5.0 grade 2 infection);\n17. Known human immunodeficiency virus (HIV) infection. A known history of clinically significant liver disease, including viral hepatitis \\[active HBV infection, i.e., positive HBV DNA (\\>1×104 copies \u002FmL or \\>2000 IU\u002Fml) must be ruled out for a known hepatitis B virus (HBV) carrier; Known hepatitis C virus infection (HCV) and HCV RNA positive (\\>1×103 copies \u002FmL);\n18. Unmitigated toxicity higher than CTCAE v5.0 grade 1 due to any previous anticancer therapy, excluding alopecia, lymphocytopenia, and oxaliplatin grade ≤2 neurotoxicity;\n19. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;\n20. Received blood transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF), within 14 days before enrollment;\n21. Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or which would affect the interpretation of the study results or place the patient at high risk;\n22. Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume \\>1.0g;\n23. The patients considered by the investigators to be unsuitable for inclusion in this study.","75 Years",{"count":493,"type":20},28,[117],"This single-arm, multicenter clinical study enrolled patients with advanced malignant melanoma who had failed previous first-line therapy (cutaneous melanoma patients were excluded), and patients with BRAF V600 mutations required targeted therapy.",[26],"2024-08-12",{"date":499,"type":35},"2024-08-14",{"date":501,"type":20},"2024-09-01",{"date":503,"type":20},"2027-09-01",{"name":505,"class":136},"Fudan University",{"id":507,"slug":508,"hasResults":11,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":21,"phases":515,"briefSummary":516,"conditions":517,"keywords":522,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":535},"100536453","phase-1-gm103-intratumoral-injection-in-patients-with-locally-advanced-unresectable-refractory-andor-metastatic-solid-tumors-100536453","NCT06265025","GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and\u002For Metastatic Solid Tumors","A Phase I\u002FII, Open-label, Dose-escalation With Expansion Study of GM103 Via Intratumoral Injection, Alone and in Combination With Pembrolizumab in Adult Patients With Locally Advanced, Unresectable, Refractory and\u002For Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Patient must be 18 years of age or over, at the time of signing the informed consent.\n2. Have a diagnosis of locally advanced, unresectable, refractory and\u002For metastatic solid tumors\n3. Have a tumor that is accessible and is willing to consent to tumor biopsies during the study.\n4. Have at least one measurable site of disease according to RECIST 1.1 criteria; The lesions should be either previously non irradiated or progressive lesions after irradiation, that can be accurately measured at baseline (for measurable lesions) with computed tomography (CT) or magnetic resonance imaging (MRI).\n5. Part A, B and C: Have at least one intratumorally injectable lesion (measurable and\u002For non-measurable based on RECIST 1.1), that can be accurately measured at baseline (for measurable lesions) with computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography-computed tomography (PET-CT); or clinical examination and which is suitable for repeated measurement.\n6. Part B and C (only for dose expansion cohort): Have paired pre- and on treatment tumor biopsies for patients with metastases that are safely accessible as determined by the investigator.\n7. Patients with brain metastasis must have stable disease and must be neurologically asymptomatic and not requiring corticosteroid treatment.\n8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n9. Have a predicted life expectancy of 12 weeks or more.\n10. Able to comply with study procedures in the Investigator's opinion.\n11. Adequate organ function determined within 4 weeks prior to screening\n12. Patient is male or female.\n13. Contraceptive use by women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n14. Patient is capable of giving signed informed consent.\n\nExclusion Criteria:\n\n1. Known history or eiciency virus \\[HIV\\]\u002Facquired immunodeficiency syndrome \\[AIDS\\]) and\u002For medication.\n2. Patients with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisolone equivalent) or other immunosuppressive medications within 14 days of the first dose of study treatment.\n3. Patients with a history of, or active, known or suspected auto-immune disease or a syndrome that requires systemic or immunosuppressive agents.\n4. Active infections requiring antibiotics, physician monitoring or recurrent fevers (\\>38.0 ̊C) associated with a clinical diagnosis of active infection.\n5. Patient who has a history of seizures, central nervous system abnormalities, mental disorders, and heart disease.\n6. Patient who has a history of pleural effusion, pulmonary embolism, and intestinal obstruction.\n7. Treatment with any systemic anticancer therapies for locally advanced or metastatic within 4 weeks or 6 half-lives of prior anticancer therapy, whichever is shorter, prior to initiation of study treatment.\n8. Previous treated with GM103 or other oncolytic viruses.\n9. Radiation therapy within 2 weeks prior to enrollment.\n10. Use of the antiviral agents within 7 days prior to the first dose of study treatment; or pegylated interferon in the 14 days before the first dose of study treatment\n11. Patients who have received a live vaccine within 30 days of study enrollment.\n12. Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results.\n13. Participation of any other clinical trials within 4 weeks prior to first administration of study treatment.\n14. Administration of an investigational drug in the 28 days before the first dose of study treatment.\n15. Has an ejection fraction (EF) of 50% or less, based on a multigated acquisition (MUGA) scan or echocardiogram (ECHO).\n16. Major surgery within 4 weeks prior to enrollment.\n17. Inability or unwillingness to follow study procedures including drug administration.\n18. Any serious medical condition or abnormality in clinical laboratory tests",{"count":514,"type":20},125,[55,23],"The purpose of this study is to measure safety, tolerability, and preliminary antitumor efficacy of GM103 administered alone and in combination with pembrolizumab in patients with locally advanced, unresectable, refractory and\u002For metastatic solid tumors (including but not limited to head and neck cancer, malignant melanoma, CRC, renal cell carcinoma, cervical cancer, and breast cancer). Study details include:",[358,26,518,519,520,521],"Colorectal Cancer","Renal Cell Carcinoma","Cervical Cancer","Breast Cancer",[523,524,525],"Oncolytic Virus","OV","Solid tumor","2024-03-20",{"date":528,"type":35},"2024-03-21",{"date":530,"type":35},"2024-02-20",{"date":532,"type":20},"2028-10-30",{"name":534,"class":42},"GeneMedicine Co., Ltd.",4,{"id":537,"slug":538,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":21,"phases":544,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":197},"100384158","phase-1-study-of-crx100-as-monotherapy-and-in-combination-with-pembrolizumab-in-patients-with-advanced-solid-malignancies-100384158","NCT04282044","Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies","A Phase 1 Study of the Safety and Efficacy of CRX100 as Monotherapy and in Combination With Pembrolizumab in Advanced Solid Malignancies","Inclusion Criteria:\n\nSubjects must meet all the following criteria to be enrolled in this study:\n\n1. Age ≥18 years at the time of consent.\n2. Written informed consent in accordance with national, local, and institutional guidelines obtained prior to any study procedures. (Screening assessments performed prior to informed consent but within the 28-day screening window are acceptable for inclusion purposes).\n3. Subjects must have histologically confirmed diagnosis of one of the following tumors: triple negative adenocarcinoma of the breast (human epidermal growth factor receptor 2 negative, estrogen receptor negative and progesterone receptor negative \\[HER2-\u002FER-\u002FPR-\\]), adenocarcinoma of the colon or rectum, hepatocellular carcinoma (HCC), osteosarcoma, epithelial ovarian cancer, malignant melanoma, non-small cell lung cancer (NSCLC), or gastric cancer. Documentation of the diagnosis with the original pathology report, or a recent biopsy, is required.\n4. Subjects must have relapsed disease or refractory disease. Subjects must have received, completed, or become intolerant of prior standard of care therapies or are not expected to derive any clinical benefit from standard of care therapies.\n5. Subjects with Ovarian cancer must have received at least one prior standard of care for their relapsed or refractory disease, which must include a platinum-based regimen.\n6. Subjects agree to provide fresh tumor tissue that has not been previously irradiated. If biopsy procedure is not safe to perform, then archival tumor tissue (20 slides or a tissue block) can be submitted.\n7. Subjects must have iRECIST evaluable disease using computed tomography (CT) or magnetic resonance imaging (MRI) with IV contrast, with at least one measurable target lesion.\n8. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n9. Subjects are expected to have a life expectancy of at least 12 weeks from the time of enrollment.\n10. Adequate hematologic function at the time of screening, defined as: absolute lymphocyte count (ALC) \\>500 cells\u002Fmm3, absolute neutrophil count (ANC) \\>750 cells\u002Fmm3, hemoglobin \\>8 g\u002FdL, and platelet count \\>50,000 cells\u002Fmm3. For subjects enrolling into the LDC cohorts, the criteria are defined as: ALC\\>500 cells\u002Fmm3, ANC\\>1000 cells\u002Fmm3, hemoglobin\\>8g\u002FdL, and platelet count\\>100,000 cells\u002Fmm3.\n\n    a. Hemoglobin and platelet count thresholds must be achievable without transfusion of red blood cells or platelets, or use of growth factors administered within two weeks.\n11. Adequate organ function, defined as:\n\n    1. Renal function: serum creatinine \\\u003C1.5x institutional upper limit of normal (ULN) or calculated creatinine clearance \\>50 mL\u002Fmin.\n    2. Adequate hepatic function: total bilirubin ≤1.5x institutional ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x institutional ULN, unless liver metastases are present, in which case it must be ≤5x ULN; International Normalized Ratio (INR) ≤1.5. For subjects with HCC, adequate hepatic function is defined as: total bilirubin ≤3x institutional upper limit of normal, AST\u002FALT ≤5x institutional ULN, INR ≤1.7, Child-Turcotte-Pugh score \\\u003C8.\n12. Women of childbearing potential (defined as all subjects physiologically capable of becoming pregnant) must have negative serum ß-human chorionic gonadotropin (hCG) or urine pregnancy test.\n13. Women of childbearing potential must agree to use highly effective methods of contraception throughout the study and for six months after the last dose of CRX100.\n14. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method throughout the study and for six months after the last dose of CRX100.\n15. Subjects must be willing and able to comply with all study procedures, requirements, and follow-up examinations.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Subjects with new or progressive brain metastasis. Subjects with treated brain metastases are eligible if there is no evidence of progression for at least four weeks after central nervous system-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.\n2. Subjects who received any chemotherapy or immunotherapies (non-cell-based therapies) or oncolytic virus therapy, radiotherapy, radiosurgery or investigational agents within three weeks of enrollment.\n3. Subjects who still are experiencing Grade 2 or higher AEs from prior therapies such as surgery, radiation therapy and systemic anti-cancer therapies unless approved by sponsor.\n4. Subjects who received any type of cell-based therapies within the last 12 weeks from the planned apheresis date.\n5. Subjects experiencing any active infections (bacterial, viral, or fungal) for which systemic antimicrobials are required. Subjects who need prophylactic anti-viral agents that can inhibit the replication of VACV will be excluded from participating.\n6. Subjects must not have history of active or symptomatic autoimmune disease or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, other symptomatic autoimmune disease, documented history of autoimmune disease or syndrome requiring systemic treatment in the past two years (i.e., with use of disease modifying agents, steroids or immunosuppressive agents) Exceptions are permitted for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring only hormone replacement, psoriasis not requiring systemic treatment, conditions not expected to recur in the absence of an external trigger or other conditions approved by the medical monitor.\n7. Have a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to apheresis, and within 14 days prior to infusion. Inhaled, intramuscular injection, or topical steroids and adrenal replacement doses (≤10 mg daily prednisone equivalents) are permitted. Stable doses of steroids are permitted for subjects with pre-treated brain metastases. Short-term (\\\u003C48 hr) steroid pretreatment for contrast allergy for imaging is permitted.\n8. Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illnesses unrelated to cancer, or any serious medical or psychiatric illness that could, in the Investigator's opinion, interfere with participation in this study.\n9. Pregnant or nursing an infant (subject or household contacts).\n10. Clinically significant immunodeficiency (e.g., due to underlying illness and\u002For medication) in a subject or household contacts.\n11. Have any underlying medical condition (including, but not limited to, ongoing or active infection requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia), psychiatric condition that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs.\n12. Have a history of another invasive malignancy, except for the following circumstance: individuals with a history of invasive malignancy are eligible if they have been disease free and off treatment for at least two years or are deemed by the Investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated: carcinoma in situ of the breast, oral cavity, or cervix, localized prostate cancer, or basal cell or squamous cell carcinoma of the skin. When enrolling a subject with another malignancy, the Investigator must discuss the subject with the Medical Monitor.",{"count":385,"type":20},[55],"This clinical study is an open-label, Phase 1, dose-escalation study to determine the safety, tolerability, and efficacy of the drug product produced by Administering CRX100 alone and in combination with Pembrolizumab in advanced solid malignancies. Patients will be screened and evaluated to determine whether or not they meet stated inclusion criteria. Enrolled subjects will undergo leukapheresis to enable the ex vivo generation of CRX100. Patients with non-small cell lung cancer (NSCLC), ovarian cancer, colorectal cancer, hepatocellular carcinoma (HCC), malignant melanoma (excluding uveal melanoma), gastric cancer, triple negative breast cancer, and osteosarcoma.\n\nThe study will start with monotherapy dose escalation followed by combination cohorts.",[547,93,518,67,548,549,550,551,26],"Solid Tumor, Adult","Osteosarcoma","Epithelial Ovarian Cancer","Gastric Cancer","Non-small Cell Lung Cancer","2024-02-07",{"date":554,"type":35},"2024-02-08",{"date":556,"type":35},"2021-01-08",{"date":558,"type":20},"2026-10",{"name":560,"class":42},"BioEclipse Therapeutics",{"id":562,"slug":563,"hasResults":11,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":567,"eligibilityCriteria":568,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":569,"targetDuration":4,"studyType":21,"phases":571,"briefSummary":572,"conditions":573,"keywords":574,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":197},"100329016","phase-2-melanoma-metastasized-to-the-brain-and-steroids-100329016","NCT03563729","Melanoma Metastasized to the Brain and Steroids","Efficacy of Immunotherapy in Melanoma Patients With Brain Metastases Treated With Steroids","MEMBRAINS","Inclusion Criteria:\n\n* Histologically confirmed metastatic melanoma with radiologically verified brain metastasis\n* Need for systemic steroid treatment (prednisolone \\> 10 mg daily; dexamethasone \\> 1.6 mg daily, hydrocortisone \\> 40 mg daily or equivalent) due to brain metastasis\n* At least one measurable lesion according to RECIST version 1.1 guidelines\n* Evaluable intracranial disease\n* 18 years of age or older\n* Performance status 0-2\n* Able to undergo MRI with gadolinium contrast agent\n* Adequate hematological and organ function\n* No significant toxicity from previous cancer treatments (CTC\\\u003C1)\n* Women of childbearing potential: Negative serum pregnancy test and must use effective contraception. This applies from screening and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered effective contraceptives\n* Men with female partner of childbearing potential must use effective contraception from screening and until 6 months after treatment. Effective contraceptives are as described above for the female partner. In addition documented vasectomy and sterility or double barrier contraception are considered effective contraceptives\n* Signed statement of consent after receiving oral and written study information.\n* Willingness to participate in the planned treatment and follow-up and capable of handling toxicities.\n* For arm E specifically: Tumor cells must harbor BRAF mutation.\n\nExclusion Criteria:\n\n* Another malignancy or concurrent malignancy unless disease-free for 3 years\n* Ocular melanoma\n* Neurological symptoms from brain metastases present at baseline despite steroid treatment, unless symptoms are related to prior surgery\n* Known hypersensitivity to one of the active drugs or excipients\n* Acute or chronic infections with HIV or hepatitis\n* Any medical condition that will interfere with patient compliance or safety\n* Prior treatment with anti-PD-1\u002FPD-L1\u002FPD-L2\u002FCTLA-4 antibodies in the metastatic setting\n* Prior systemic treatment with anti-PD-1\u002FPD-L1\u002FPD-L2\u002FCTLA-4 antibodies in the adjuvant setting, unless completed more than 6 months before enrolment in this study\n* Simultaneous treatment with other experimental drugs or other anti-cancer drugs\n* Pregnant or breastfeeding females.\n* For arm E specifically: Prior treatment with BRAF\u002FMEK inhibitors.",{"count":570,"type":20},80,[23],"This clinical trial is to clarify whether treatment with a checkpoint inhibitor alone (pembrolizumab) or two in combination (ipilimumab and nivolumab), results in clinical benefit for MM patients with brain metastases and in need of steroid treatment. Patients will be treated in four arms depending on steroid dose level at inclusion (\\> 10 \\\u003C 25 mg prednisolone or \\> 25 mg prednisolone) and treatment (pembrolizumab alone or the combination of ipilimumab and nivolumab).",[26],[575,576,577,578,579,580,581,582,583],"Immune therapy","checkpoint inhibitor","pembrolizumab","ipilimumab","nivolumab","steroid","brain metastasis","BRAF inhibitor","MEK inhibitor","2023-07-12",{"date":586,"type":35},"2023-07-13",{"date":588,"type":35},"2018-06-06",{"date":590,"type":20},"2028-06-06",{"name":592,"class":136},"Inge Marie Svane",{"id":594,"slug":595,"hasResults":11,"nctId":596,"briefTitle":597,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":330,"phases":4,"briefSummary":602,"conditions":603,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":137},"100442164","the-gut-microbiome-and-immune-checkpoint-inhibitor-therapy-in-solid-tumors-100442164","NCT05037825","The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors","PARADIGM","Inclusion Criteria:\n\n1. Men or women ≥18 years of age\n2. Screened negative for COVID-19 symptoms at time of consent, as per institutional policy and as applicable for the duration of the COVID-19 pandemic\n3. Diagnosed with stages I-IV primary NSCLC, MM, TNBC or RCC\n4. Plan to be treated at a partner cancer site with a checkpoint inhibitor (anti-PD-1, anti-PD-L1, or anti-CTLA-4) as a single agent or in combination with another checkpoint inhibitor or other treatment agent or modality (e.g., targeted therapy, chemotherapy, surgery, radiation, etc.) in accordance with FDA-labeled use of the agent\n5. Able to provide informed consent and answer study questionnaires in either English or Spanish\n6. Able to provide stool specimens for research purposes\n\nExclusion Criteria:\n\n1. Mental incapacity\n2. Incarcerated individuals\n3. Pregnancy (by self-report of pregnancy status)\n4. Experiencing active brain metastasis\u002Fmetastases\n5. Treatment with checkpoint inhibitor in off-label capacity or through a clinical\u002Finterventional trial\n6. Active participation in an immuno-oncology clinical\u002Finterventional trial or pharma-sponsored observational study",{"count":601,"type":20},800,"The microbiome has the potential to serve as a robust biomarker of clinical response to immunotherapy. Additionally, microbial manipulation, through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, may prove to be beneficial in promoting anti-tumor immune responses. However, large prospective studies in humans with longitudinal sample collection and standardized methods are needed to understand how microbiota and their byproducts affect cancer therapies, particularly among patients undergoing identical therapy but experiencing different outcomes. The proposed observational study builds upon these hypotheses by proposing a large cohort design to further assess the associations between the gut microbiota (composition and function), host immune system, and ICI treatment efficacy across multiple cancer types.",[604,26,519,605],"Non-Small-Cell Lung Carcinoma","Triple-Negative Breast Cancer","2022-04-25",{"date":608,"type":35},"2022-04-27",{"date":610,"type":35},"2021-11-22",{"date":612,"type":20},"2028-09-14",{"name":614,"class":42},"VastBiome",{"id":616,"slug":617,"hasResults":11,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":621,"eligibilityCriteria":622,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":623,"targetDuration":4,"studyType":21,"phases":625,"briefSummary":626,"conditions":627,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":137},"100372244","phase-2-a-randomized-controlled-phase-ii-trial-with-intradermal-imo-2125-in-pathological-tumor-stage-p-t3-4-cn0m0-melanoma-100372244","NCT04126876","A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma","A Randomized Controlled Phase II Clinical Trial With Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma","INTRIM","Inclusion Criteria:\n\n* 18 years or older\n* Histologically confirmed primary malignant melanoma cutis with a Breslow tumor depth \\>2.0 mm\n* Scheduled to undergo a combines re-excision and sentinel node biopsy (SNB)\n* World Health Organization (WHO) Performance Status ≤1\n* Agreement to use effective contraceptive methods from screening until at least 90 days after the IMO-2125 administration\n* Written informed consent\n\nExclusion Criteria:\n\n* Known hypersensitivity to any oligodeoxynucleotide\n* Active auto-immune disease requiring disease-modifying therapy at the tumr of screening\n* Pathologically confirmed loco-regional or distant metastasis\n* Non-skin melanoma\n* Patients with another primary malignancy (some exceptions)\n* Active systemic infections requiring antibiotics\n* Women who are pregnant or breast-feeding",{"count":624,"type":20},214,[23],"Currently, there is no widely used adjuvant treatment available to improve survival after surgical excision of a primary melanoma. In a previous study, loco-regional and systemic immune stimulations, as well as favourable clinical outcomes in terms of sentinel lymph node (SLN) tumor status and recurrence-free survival (RFS) in patients with clinical stage I-II melanoma who received a low dose of toll-like receptor 9 (TLR-9) CPG7909 (CpG-B ODN) intradermally at the excision site of the primary tumor prior to SLN biopsy (SNB) were described. In this phase II trial the investigators had investigated the clinical activity of a next-generation CpG-ODN, IMO-2125, and it's ability to induce loco-regional and systemic immune stimulation in pT3-4 cN0M0 melanoma patients who are scheduled to undergo a combined re-excision and SNB is",[26],"2021-04-14",{"date":630,"type":35},"2021-04-15",{"date":632,"type":35},"2020-01-22",{"date":634,"type":20},"2031-11-01",{"name":636,"class":136},"A.J.M. van den Eertwegh"]