[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"melanoma-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:melanoma-metastatic":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,43,76,108,142,170,196,209,233,257,286,309],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100053563","phase-2-a-phase-ii-clinical-study-of-multimodal-ablation-combined-with-systemic-drug-therapy-for-advanced-solid-tumors-100053563",false,"NCT06889610","A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.","A Single-center,Multi-cohort,Prospective Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.","Inclusion Criteria i. Common eligibility criteria for all cohorts:\n\n1\\. Age between 18-80 years,gender not limited; 2. Patients with hepatic lesions amenable to ablation, all hepatic lesions \\\u003C5 cm in diameter; 3. Expected survival≥3 months; 4. ECOG performance status score of 0-1; 5. Within 14 days before the first dose,laboratory tests indicate adequate organ function:\n\na) Hematology:WBC≥3.0×10\\^9\u002FL;ANC≥1.5×10\\^9\u002FL;PLT≥75×10\\^9\u002FL;HGB≥90 g\u002FL b) Liver function:Child-Pugh score≤7,AST≤5.0×ULN;ALT≤5.0×ULN;TBIL≤1.5×ULN c) Renal function:Cr≤1.5×ULN or CrCl≥60 mL\u002Fmin d) Coagulation function:INR≤1.5×ULN(for patients on anticoagulant therapy,≤3×ULN,anticoagulants must be discontinued one week before ablation);APTT≤1.5×ULN ii. Additional eligibility criteria for each cohort:\n\n1. Colorectal Cancer：\n\n   a) Clinically or pathologically confirmed colorectal cancer with liver metastases that are unresectable, or the patient is intolerant to or refuses surgery; b) Patients who have failed standard second-line drug therapy.\n2. Triple-negative breast cancer :\n\n   1. Clinically or pathologically confirmed triple-negative breast cancer(triple-negative defined as\\\u003C1% nuclear staining for ER and PR expression and HER2 negative);\n   2. Patients who have failed standard second-line drug therapy(including those who have failed PD-1 monoclonal antibody therapy, with progression within six months of adjuvant or neoadjuvant therapy considered as first-line therapy failure).\n3. Melanoma :\n\n   1. Clinically or pathologically confirmed melanoma liver metastasis, with inoperable or intolerable liver lesions or refusal of surgical resection;\n   2. Patients who have failed standard first-line drug therapy.\n\nExclusion Criteria:\n\ni. Common exclusion criteria for all cohorts:\n\n1. Patients with known allergy or suspected allergy to the study drugs or similar drugs;\n2. Patients who have participated in another clinical study and received at least one treatment within 4 weeks prior to enrollment;\n3. History or concurrent presence of other malignant tumors(except for cured basal cell carcinoma of the skin,superficial bladder cancer,carcinoma in situ of the cervix,and papillary thyroid carcinoma);\n4. Patients with immunodeficiency diseases within 7 days prior to the first dose,or currently receiving systemic corticosteroid therapy(≥10mg\u002Fday prednisone or equivalent dose of other corticosteroids),or other forms of immunosuppressive therapy;\n5. Symptomatic central nervous system(CNS)metastases,or other evidence indicating that the CNS metastases have not been controlled,and deemed unsuitable for enrollment by the investigator;\n6. Patients who have previously undergone organ or bone marrow transplantation;\n7. Uncontrollable pleural effusion,pericardial effusion,or ascites causing respiratory syndrome(≥CTCAE grade 2 dyspnea);\n8. Esophageal(gastric fundus)variceal rupture bleeding within the last month;\n9. Other antitumor treatments outside the combined regimen,such as radiotherapy,systemic chemotherapy,etc.;\n10. Clinically significant electrolyte abnormalities as judged by the investigator;\n11. Insufficiency or failure of major organs;\n12. Patients who have received systemic drug therapy,radiotherapy,or local liver treatment,with a time interval of less than 1 month since the last systemic treatment or local liver treatment;\n13. Patients who have received immunotherapy and experienced grade 3 or higher immune-related adverse events(irAEs)(except for thyroid function abnormalities,blood sugar abnormalities);\n14. Active or uncontrolled severe infections(≥CTCAE grade 2 infections);\n15. Any other disease,clinically significant metabolic abnormalities,physical examination abnormalities,or laboratory test abnormalities that,in the investigator's judgment,may have a disease or condition that makes the patient unsuitable for the study drug,or may affect the interpretation of the study results,or may place the patient at high risk;\n16. Pregnant or breastfeeding women,or women of childbearing age with a positive baseline pregnancy test;\n17. Known human immunodeficiency virus(HIV)infection;known clinically significant liver disease history,including viral hepatitis\\[known carriers of hepatitis B virus(HBV)must exclude active HBV infection,i.e.,HBV DNA positive(\\>1×10\\^4 copies\u002FmL or\\>2000 IU\u002FmL);known hepatitis C virus(HCV)infection and HCV RNA positive(\\>1×10\\^3 copies\u002FmL),or other hepatitis,cirrhosis;\n18. Patients with severe heart,lung,liver,or kidney dysfunction,irreversible coagulation disorders,or other uncontrolled diseases(including hypertension or diabetes,active infections,mental illness,or social conditions that may affect patient compliance);\n19. Other factors that may affect patient safety or trial compliance as judged by the investigator.\n\nii. Additional exclusion criteria for each cohort:\n\n1. Colorectal Cancer :\n\n   a) Patients with uncontrolled hypertension, defined as: patients with hypertension that cannot be well-controlled with a single antihypertensive agent (SBP ≥150 mmHg or DBP ≥100 mmHg); or patients who require two or more antihypertensive medications to control blood pressure.\n\n   b）Patients with urine dipstick proteinuria ≥2+ and a 24-hour urinary protein level \\>1.0 g.\n\n   c）Patients with gastrointestinal diseases such as active gastric or duodenal ulcers, ulcerative colitis, or active bleeding from an unresected tumor; or other conditions judged by the investigator as potentially causing gastrointestinal bleeding or perforation.\n\n   d）Patients with evidence or history of a significant bleeding tendency within 3 months prior to enrollment (e.g., bleeding \\>30 mL, hematemesis, melena, hematochezia), hemoptysis (\\>5 mL of fresh blood within 4 weeks), or a thromboembolic event (including stroke and\u002For transient ischemic attack) within the past 12 months.\n\n   e）Patients with clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within 6 months prior to enrollment.\n\n   f）Congestive heart failure of New York Heart Association (NYHA) class \\> II; ventricular arrhythmias requiring medication; or an ECG showing a QTc interval ≥480 milliseconds.\n\n   g）Patients who are unable to take fruquintinib orally.\n2. Triple-negative breast cancer :\n\n   a) Patients who have previously received pucotenlimab treatment;\n3. Melanoma :\n\n   1. Patients who have previously received pembrolizumab or toripalimab treatment;\n   2. Patients currently have uncontrolled hypertension,defined as:patients with hypertension that cannot be well controlled with monotherapy(systolic blood pressure≥150 mmHg,or diastolic blood pressure≥100 mmHg);or patients using two or more antihypertensive drugs to control blood pressure;\n   3. Urine routine indicates proteinuria≥2+,and 24-hour urine protein\\>1.0g;\n   4. Significant clinically meaningful cardiovascular diseases,including but not limited to acute myocardial infarction,severe\u002Funstable angina,or coronary artery bypass grafting within 6 months before enrollment;\n   5. Congestive heart failure New York Heart Association(NYHA)classification\\>2;ventricular arrhythmias requiring drug treatment;electrocardiogram(ECG)showing QTc interval≥480 milliseconds.","ALL","18 Years","80 Years",{"count":20,"type":21},95,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study focuses on the treatment of liver metastases from three common cancers: colorectal cancer, triple-negative breast cancer and melanoma. Currently, there are limitations in the treatment of liver metastases of these cancers. Multimodal thermophysical ablation therapy can reshape the tumor microenvironment, release neoantigens, and act as an in-situ vaccine. On this basis, the combination of multimodal ablation with immunotherapeutic drugs such as pucotenlimab will be explored. The efficacy and safety of this combination therapy in patients with liver metastases of solid tumors will be investigated, with the expectation of breaking through the existing treatment limitations.",[27,28,29],"Triple Negative Breast Cancer Metastatic","Melanoma Metastatic","Colorectal Cancer Metastatic","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2026-03-30",{"date":38,"type":21},"2028-12-30",{"name":40,"class":41},"Fudan University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":42},"100642267","phase-2-a-phase-ii-trial-of-tumour-infiltrating-lymphocyte-adoptive-cell-therapy-in-patients-with-immune-checkpoint-inhibitor-resistant-unresectable-or-metastatic-melanoma-100642267","NCT07651618","A Phase II Trial of Tumour Infiltrating Lymphocyte Adoptive Cell Therapy in Patients With Immune Checkpoint Inhibitor Resistant Unresectable or Metastatic Melanoma","PERTIL-01: A Phase II Trial of Tumour Infiltrating Lymphocyte Adoptive Cell Therapy in Patients With Immune Checkpoint Inhibitor Resistant Unresectable or Metastatic Melanoma","PERTIL-01","Inclusion Criteria:\n\n1. Adult patients = 18 years = 70 years of age.\n2. ECOG 0-1 (Appendix A: Eastern Cooperative Oncology Group Performance Status Scale) with an estimated life expectancy of \\> 6 months\n3. Histologically confirmed unresectable or stage IV melanoma as per AJCC 8th edition. Unresectable melanoma is defined where the lesions are deemed to be unresectable by the treating surgeon.\n4. Metastatic melanoma with at least 1 surgically accessible metastatic lesion (or aggregate lesions) with an estimated minimum diameter of = 1.5 cm\n5. Measurable disease per RECIST 1.1 criteria (in addition to the resected lesion).\n6. At least one anti-PD1 containing line of systemic therapy for unresectable or metastatic melanoma. Alternatively, one prior line of an adjuvant or neoadjuvant anti-PD1 containing regimen and all related adverse events have either returned to baseline or stabilized.\n\nExclusion Criteria:\n\n1. Life expectancy of less than 3 months.\n2. Metastatic uveal melanoma.\n3. Requirement for immunosuppressive doses of systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive drugs (e.g. mycophenolate, infliximab, or others) within the last 3 weeks prior to patient screening. Participants receiving steroids as replacement therapy for adrenocortical insufficiency at =10 mg\u002Fday of prednisone or another steroid equivalent dose are acceptable.\n4. Participant has symptomatic untreated brain metastases.\n\n   * A participant with historically treated brain metastases (ie, treatment was completed \\>60 days prior to consenting for study participation) may be considered for study participation if the participant is clinically and radiologically stable for = 60 days\n   * Participants with previously known asymptomatic brain metastases who do not clinically require treatment may be enrolled.\n5. More than three melanoma brain metastases or evidence of leptomeningeal disease\n\nOther protocol defined exclusion criteria could apply.","70 Years",{"count":53,"type":21},10,[24],"The goal of this study is to determine the activity of Perkileucel, a tumour infiltrating lymphocyte (TIL) adoptive cell transfer therapy (ACT), in patients with unresectable stage III or metastatic melanoma who have progressed on previous treatment with immune checkpoint inhibitors in the adjuvant or metastatic setting.\n\nStudy details:\n\nAll participants will receive the investigational treatment, Perkileucel. To create this therapy, participants need to undergo surgical excision of a melanoma lesion to harvest the TILs prior to treatment. Once the TILs have been manufactured, participants will be admitted to hospital to receive 5 days of chemotherapy to prepare their body (lymphodepletion) for the TIL-ACT. Treatment with TIL-ACT will then be given on Day 0 as a single intravenous infusion followed by up to 6 intravenous infusions of high-dose interleukin 2. Blood tests and other assessments will be performed regularly to monitor safety and response.\n\nThe total duration of the study is 8 years. Safety will be assessed throughout the full duration of the study. Patients will be monitored for delayed adverse events.\n\nThis study will show whether Perkileucel can help control melanoma that has not responded to other treatments and demonstrate feasibility of manufacture and delivery of this treatment in an Australian healthcare setting.",[57,28],"Melanoma (Skin Cancer)",[59,60,61,62,63,64],"Unresectable Melanoma","Melanoma","Perkileucel","TILs","Tumour Infiltrating Lymphocytes","Metastatic Melanoma","NOT_YET_RECRUITING","2026-06-11",{"date":68,"type":34},"2026-06-16",{"date":70,"type":21},"2026-07",{"date":72,"type":21},"2032-04",{"name":74,"class":75},"East Metropolitan Health Service, Australia","OTHER_GOV",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100584471","phase-1-ny-eso-1-redirected-t-cells-in-patients-with-advanced-melanoma-and-sarcoma-100584471","NCT06889766","NY-ESO-1-redirected T Cells in Patients With Advanced Melanoma and Sarcoma","A Phase I Study Evaluating Safety and Feasibility of Redirected Autologous T Cells Expressing a High Affinity TCR Specific for NY-ESO-1 (LauT-1) in Patients With Advanced Melanoma and Sarcoma","LauT1","Inclusion criteria at pre-screening\n\n1\\) Patients with histologically confirmed advanced or metastatic cutaneous melanoma or any type of sarcoma.\n\nInclusion criteria at screening\n\n1. Patients with sarcoma, who have received at least one line of standard therapy (if available) and failed to respond, progressed or were intolerant to that therapy, will be eligible. If the participant refuses or is, in the opinion of the investigator, ineligible for these treatments, the reason must be documented in the medical record.\n2. Patients with metastatic melanoma:\n\n   1. Without proto-oncogene B-Raf (BRAF) mutation who have received at least one line of standard therapy and failed to respond, progressed or were intolerant to that therapy, will be eligible. If the participant refuses or is, in the opinion of the investigator, ineligible for these treatments, the reason must be documented in the medical record.\n   2. With BRAF mutation who have received at least two lines of standard therapy and failed to respond, progressed or were intolerant to that therapy, will be eligible. If the participant refuses or is, in the opinion of the investigator, ineligible for these treatments, the reason must be documented in the medical record.\n3. Patient must have immunohistochemically documented NY-ESO-1 expression, defined as ≥ 1+ expression on either archival or fresh tumor tissue by immunohistochemistry, in ≥50% of the sampled tumor tissue AND HLA-A\\*0201 and\u002For HLA-A\\*0205 positive, as identified by high-resolution genomic deoxyribonucleic acid (DNA) typing of the HLA-A locus.\n4. Age ≥ 18 years\n5. Able to undergo apheresis\n6. At least one lesion accessible to biopsy for translational research (TR) at D30, without putting the patient at unusual risk.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n8. Life expectancy of greater than 12 weeks.\n9. Radiologically measurable disease (as per RECIST v1.1).\n10. Adequate organ function\n\nExclusion Criteria:\n\n1. Patients with an active second malignancy\n2. Patients with symptomatic and\u002For untreated brain metastases, as well as leptomeningeal carcinomatosis. Patients with definitively treated brain metastases will be considered for enrolment after agreement with the Principal Investigator, as long as lesions are stable, there are no new brain lesions, and the patient does not require chronic corticosteroid treatment.\n3. History of idiopathic pulmonary fibrosis or evidence of active pneumonitis (any origin). History of radiation pneumonitis in the radiation field (fibrosis) is allowed.\n4. History of recent myocardial infarction, or unstable angina, within six months prior to enrolment\n5. Patients with prior allogeneic stem cell transplantation or organ transplantation\n6. Active severe systemic infections within 2 weeks prior to apheresis\n7. Patient requiring regular systemic immunosuppressive therapy. All immunosuppressive medications including but not limited to steroids, mycophenolate mofetil, azathioprine, methotrexate, thalidomide, and anti-Tumor Necrosis Factor-alpha (TNF-alpha) agents must have been discontinued at least 2 weeks before apheresis .\n8. History of severe immediate hypersensitivity reaction to any of the agents\u002F excipients of the study products.\n9. Women who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.\n10. Subjects, for whom there are concerns that they will not reliably comply with the requirements for contraception, should not be enrolled into the study.\n11. Any serious underlying medical condition that could interfere with study medication and potential adverse events.",{"count":85,"type":21},9,[87],"PHASE1","A single center, dose escalaion, Phase I clinical trial to demonstrate safety and efficacy of LauT-1, autologous \"New York Esophageal Squamous Cell Carcinoma-1 T-Cell Receptor (NY-ESO-1 TCR)-directed T cells in combination with non-myeloablative (NMA) lymphodepleting chemotherapy and low dose irradiation (LDI) in patients with NY-ESO-1 positive sarcoma and melanoma.",[90,28,91],"Advanced Melanoma","Sarcoma",[93,94,95,96,91,97],"NY-ESO-1","LauT-1","TCR redirected T cell","metastatic melanoma","autolog T-cell","2026-05-12",{"date":100,"type":34},"2026-05-15",{"date":102,"type":34},"2025-03-24",{"date":104,"type":21},"2029-06",{"name":106,"class":41},"Centre Hospitalier Universitaire Vaudois",2,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":141},"100575055","phase-2-stereotactic-ablative-radiotherapy-xrt-and-immunotherapy-for-oligometastatic-extracranial-melanoma-100575055","NCT06767306","Stereotactic Ablative Radiotherapy (XRT) and Immunotherapy for Oligometastatic Extracranial Melanoma","A Phase II, Multicentre, Non-Comparative, Randomised Controlled Trial of Stereotactic Ablative Body Radiotherapy and Immunotherapy Versus Immunotherapy Alone in Patients With Treatment Naïve Oligometastatic Extracranial Melanoma","AXIOM","Inclusion Criteria:\n\n* Female or male patients, age 18 or older\n* Willing to provide signed informed consent\n* Life expectancy \\> 6 months\n* First presentation of AJCC Stage IV (any N, M1a, M1b, M1c), histologically confirmed cutaneous, acral or unknown primary melanoma with one to five extracranial metastases detected on CT and whole body PET-CT, and considered unresectable\n* A primary lesion and \u002F or up to 4 in-transit metastases(is) (ITM) in addition to distant metastases(is) are permitted and will be counted in the maximum number of permitted baseline lesions\n* Prior surgery for symptomatic disease (e.g. small bowel obstruction) for this first presentation of Stage IV melanoma is permitted, provided the total number of remaining extracranial metastases is ≤ 5 (NOT including the resected lesion). No more than one excised metastatic lesion is permitted\n* At least one metastasis should be measurable as a target lesion per RECIST version 1.1\n* No evidence of cerebral metastases on MRI brain (CT brain is acceptable if there is contraindication to MRI)\n* All lesions can be treated with a minimum SBRT biologically effective dose (BED) of 48Gy\n* Able to tolerate treatment with immunotherapy as determined by the medical oncologist\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of randomisation\n\nExclusion Criteria:\n\n* Ocular or mucosal melanoma\n* Serious or unstable medical co-morbidities or other conditions that could interfere with the patient's safety, consent, or compliance\n* Patients for whom there is a definite and immediate indication for radiotherapy (e.g., spinal cord compression, rapidly progressing disease associated with clinical signs and symptoms)\n* Prior radiotherapy for Stage IV disease (prior adjuvant radiotherapy to primary site or nodal field (Stage I-III disease) is permitted, however adjuvant-treated sites must not be included in the baseline lesions\n* Inability to treat all disease sites with SBRT as determined by radiation oncologist\n* Prior systemic drug therapy for melanoma, unless given in the neoadjuvant or adjuvant setting for Stage I-III disease\n* Any contraindication to the planned standard of care immunotherapy regimen per regulatory approved product information\n* For patients with liver metastases - moderate\u002Fsevere liver dysfunction\n* A known history of another malignancy or concurrent malignancy unless the patient is disease-free for a minimum of 1 year, is completely treated and is at low risk of recurrence\n* Pregnant or breastfeeding females",{"count":117,"type":21},129,[24],"The purpose of this research is to evaluate the addition of radiotherapy to the standard immunotherapy drugs that are given to patients with advanced or metastatic melanoma that has spread to other parts of the body. Radiotherapy uses x-rays to target and kill melanoma cells and immunotherapy works by activating the body's own immune system to seek out and fight melanoma cells. Both of these treatments are commonly given to patients with advanced melanoma and other cancers. Both treatments are usually given separately but can also be given together. The aim of this research is to find out if giving radiotherapy and immunotherapy together is better than giving immunotherapy alone.\n\nThe type of radiotherapy to be used in this project is known as 'stereotactic' body radiotherapy or SBRT (also known as stereotactic body ablative radiotherapy, SABR). SBRT targets the radiation very precisely at the metastatic deposits in the body. This method protects the healthy areas near the melanoma. SBRT works by delivering a high dose of radiation precisely to the areas of melanoma which causes the melanoma cells to break apart and eventually die. SBRT is given in 'fractions' which means the high dose is given in small measures over several days, depending on the number and size of metastases.",[28],[122,123,124,125,126,127,128,129,130,131],"SABR","stereotactic body radiotherapy","Stereotactic Ablative Body Radiotherapy","SABRT","Immunotherapy","Immune Checkpoint Inhibitors","Oligometastases","Extracranial","Quality of life","Biomarkers","2026-05-03",{"date":134,"type":34},"2026-05-07",{"date":136,"type":34},"2025-03-06",{"date":138,"type":21},"2033-04-01",{"name":140,"class":41},"Melanoma Institute Australia",5,{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":156,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":169},"100598827","phase-1-a-phase-1-1b-study-to-evaluate-the-safety-efficacy-and-dosimetry-of-study-drug-a9-3408-in-subjects-with-metastatic-melanoma-100598827","NCT07076550","A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of Study Drug A9-3408 in Subjects With Metastatic Melanoma","A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of [225Ac]Ac-A9-3408 in Subjects With Unresectable or Metastatic Melanoma","Inclusion Criteria:\n\n* Able to provide written informed consent\n* \\[68Ga\\]Ga-A9T-3202 uptake in at least one measurable lesion (per RECIST v1.1) on PET scan\n* Histologically or cytologically confirmed unresectable or metastatic melanoma with disease progression on prior standard of care therapy\n* Adequate ECOG performance status\n* Adequate baseline organ function within 14 days of first dose of investigational product\n* Recovered from side effects of prior anticancer therapy\n* Women of childbearing potential (WOCBP) must have a negative pregnancy test and follow adequate birth control method(s) during the treatment period and for at least 6 months after last dose of \\[225Ac\\]Ac-A9-3408. Sexually active males with partners who are WOCBP must agree to adequate birth control method(s) during the treatment period and for at least 3 months after last dose of \\[225Ac\\]Ac-A9-3408\n\nExclusion Criteria:\n\n* Previous treatment with radioactive nuclides except radioactive imaging tracers\n* Treatment with another investigational product shortly prior to first dose of \\[225Ac\\]Ac-A9-3408 with exception of anti-PD-1\u002FPD-L1 agents.\n* Concurrent anticancer therapy\n* Major surgery within 4 weeks of first dose of investigational product\n* Second malignancy within 2 years\n* Active, clinically serious infection\n* Known infusion reactions to components of the investigational product\n* Other clinically serious health conditions including cardiovascular and or severe infectious diseases\n* Significant central nervous system metastatic disease\n* Pregnant, breastfeeding or unwilling to practice adequate birth control method(s)\n* Any condition per the opinion of the investigator that would impact the safety of the subject, protocol adherence or ability to provide informed consent",{"count":150,"type":21},50,[87],"The goal of this trial is to see if this investigational drug is safe for adult patients with melanoma that has spread to other parts of the body or cannot be removed by surgery. It will also see if this investigational drug can shrink melanoma tumors in the body. The main questions this study aims to answer are:\n\n* What are the side effects of this investigational drug?\n* What is the highest dose of this investigational drug that can be given safely?\n\nParticipants will:\n\n* Take the investigational drug once every 6 weeks, for up to 6 times in total\n* Visit a doctor's office on a regular basis for checkups and tests",[28,154,155],"Uveal Melanoma, Metastatic","Mucosal Melanoma",[64,60,157,158],"Radiopharmaceuticals","Theranostic","2026-03-12",{"date":161,"type":34},"2026-03-16",{"date":163,"type":34},"2025-11-19",{"date":165,"type":21},"2028-01",{"name":167,"class":168},"Alpha-9 Oncology USA Inc.","INDUSTRY",4,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":180,"phases":4,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":4},"100626950","pd-l1-targeting-peptide-probe-for-pet-imaging-of-solid-tumor-100626950","NCT07442292","PD-L1 Targeting Peptide Probe for PET Imaging of Solid Tumor","PD-L1 Targeting Peptide Probe 68Ga-cPP-BCH for PET Imaging of Solid Tumor","Inclusion Criteria:\n\n1. Aged 18-75, male and female, with ECOG score of 0 or 1;\n2. Subjects with lung cancer, melanoma, or other solid tumors scheduled for immunotherapy or combined immunotherapy;\n3. underwent PD-L1 IHC examination before therapy;\n4. The expected survival was more than 26 weeks;\n5. Blood routine test, liver and kidney function meet the following standards: blood routine: WBC \\>= 4.0 x 10\\^9\u002FL or neutrophil \\>= 1.5 x 10\\^9\u002F:, PLT \\>= 100 x 10\\^9 \u002F L, Hb \\>= 90g \u002F L; Pt or APTT \\\u003C= 1.5 upper limit of normal value; liver and kidney function: total bilirubin \\\u003C= 1.5 x ULT (upper limit of normal value), ALT \u002F AST \\\u003C= 2.5 upper limit of normal value or \\\u003C= 5 x ULT (subject with liver metastasis), ALP \\\u003C= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP \\\u003C= 4.5 upper limit of normal value); BUN \\\u003C= 1.5 x ULT, SCR \\\u003C= 1.5 x ULT;\n6. According to RECIST1.1, there was at least one measurable target lesion;\n7. Understand and sign informed consent voluntarily with good compliance.\n\nExclusion Criteria:\n\n1. The function of liver and kidney was seriously abnormal;\n2. Preparation for pregnant, pregnant and lactating women;\n3. Inability to lie flat for half an hour;\n4. Suffering from claustrophobia or other mental disorders;\n5. Other researchers considered it unsuitable to participate in the trial.","75 Years",{"count":179,"type":21},40,"OBSERVATIONAL","The objective of this study is to construct a noninvasive approach using radiolabbled peptide 68Ga-cPP-BCH PET\u002FCT to detect the PD-L1 expression of tumor lesion in patients with lung cancer, melanoma and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.",[183,184,57,28,185,186],"Lung Cancer (NSCLC)","Lung Cancer (SCLC)","PD-L1","PET \u002F CT","2026-03-03",{"date":189,"type":34},"2026-03-05",{"date":191,"type":21},"2026-02",{"date":193,"type":21},"2027-06",{"name":195,"class":41},"Peking University Cancer Hospital & Institute",{"id":197,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":25,"conditions":201,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":208,"locationsCount":42},"100584459","Inclusion Criteria i. Common eligibility criteria for all cohorts:\n\n1\\. Age between 18-80 years,gender not limited; 2. The number of liver metastases is≥3.Besides the ablation lesions,there must be at least one measurable lesion(≥1cm),and the diameter of the ablation lesions is\\\u003C5cm; 3. Expected survival≥3 months; 4. ECOG performance status score of 0-1; 5. Within 14 days before the first dose,laboratory tests indicate adequate organ function:\n\na) Hematology:WBC≥3.0×10\\^9\u002FL;ANC≥1.5×10\\^9\u002FL;PLT≥75×10\\^9\u002FL;HGB≥90 g\u002FL b) Liver function:Child-Pugh score≤7,AST≤5.0×ULN;ALT≤5.0×ULN;TBIL≤1.5×ULN c) Renal function:Cr≤1.5×ULN or CrCl≥60 mL\u002Fmin d) Coagulation function:INR≤1.5×ULN(for patients on anticoagulant therapy,≤3×ULN,anticoagulants must be discontinued one week before ablation);APTT≤1.5×ULN ii. Additional eligibility criteria for each cohort:\n\n1. Colorectal Cancer：\n\n   a) Clinically or pathologically confirmed colorectal cancer with liver metastases that are unresectable, or the patient is intolerant to or refuses surgery; b) Patients who have failed standard second-line drug therapy.\n2. Triple-negative breast cancer :\n\n   1. Clinically or pathologically confirmed triple-negative breast cancer(triple-negative defined as\\\u003C1% nuclear staining for ER and PR expression and HER2 negative);\n   2. Patients who have failed standard second-line drug therapy(including those who have failed PD-1 monoclonal antibody therapy, with progression within six months of adjuvant or neoadjuvant therapy considered as first-line therapy failure).\n3. Melanoma :\n\n   1. Clinically or pathologically confirmed melanoma liver metastasis, with inoperable or intolerable liver lesions or refusal of surgical resection;\n   2. Patients who have failed standard first-line drug therapy.\n\nExclusion Criteria:\n\ni. Common exclusion criteria for all cohorts:\n\n1. Patients with known allergy or suspected allergy to the study drugs or similar drugs;\n2. Patients who have participated in another clinical study and received at least one treatment within 4 weeks prior to enrollment;\n3. History or concurrent presence of other malignant tumors(except for cured basal cell carcinoma of the skin,superficial bladder cancer,carcinoma in situ of the cervix,and papillary thyroid carcinoma);\n4. Patients with immunodeficiency diseases within 7 days prior to the first dose,or currently receiving systemic corticosteroid therapy(≥10mg\u002Fday prednisone or equivalent dose of other corticosteroids),or other forms of immunosuppressive therapy;\n5. Symptomatic central nervous system(CNS)metastases,or other evidence indicating that the CNS metastases have not been controlled,and deemed unsuitable for enrollment by the investigator;\n6. Patients who have previously undergone organ or bone marrow transplantation;\n7. Uncontrollable pleural effusion,pericardial effusion,or ascites causing respiratory syndrome(≥CTCAE grade 2 dyspnea);\n8. Esophageal(gastric fundus)variceal rupture bleeding within the last month;\n9. Other antitumor treatments outside the combined regimen,such as radiotherapy,systemic chemotherapy,etc.;\n10. Clinically significant electrolyte abnormalities as judged by the investigator;\n11. Insufficiency or failure of major organs;\n12. Patients who have received systemic drug therapy,radiotherapy,or local liver treatment,with a time interval of less than 1 month since the last systemic treatment or local liver treatment;\n13. Patients who have received immunotherapy and experienced grade 3 or higher immune-related adverse events(irAEs)(except for thyroid function abnormalities,blood sugar abnormalities);\n14. Active or uncontrolled severe infections(≥CTCAE grade 2 infections);\n15. Any other disease,clinically significant metabolic abnormalities,physical examination abnormalities,or laboratory test abnormalities that,in the investigator's judgment,may have a disease or condition that makes the patient unsuitable for the study drug,or may affect the interpretation of the study results,or may place the patient at high risk;\n16. Pregnant or breastfeeding women,or women of childbearing age with a positive baseline pregnancy test;\n17. Known human immunodeficiency virus(HIV)infection;known clinically significant liver disease history,including viral hepatitis\\[known carriers of hepatitis B virus(HBV)must exclude active HBV infection,i.e.,HBV DNA positive(\\>1×10\\^4 copies\u002FmL or\\>2000 IU\u002FmL);known hepatitis C virus(HCV)infection and HCV RNA positive(\\>1×10\\^3 copies\u002FmL),or other hepatitis,cirrhosis;\n18. Patients with severe heart,lung,liver,or kidney dysfunction,irreversible coagulation disorders,or other uncontrolled diseases(including hypertension or diabetes,active infections,mental illness,or social conditions that may affect patient compliance);\n19. Other factors that may affect patient safety or trial compliance as judged by the investigator.\n\nii. Additional exclusion criteria for each cohort:\n\n1. Colorectal Cancer :\n\n   a) Patients with uncontrolled hypertension, defined as: patients with hypertension that cannot be well-controlled with a single antihypertensive agent (SBP ≥150 mmHg or DBP ≥100 mmHg); or patients who require two or more antihypertensive medications to control blood pressure.\n\n   b）Patients with urine dipstick proteinuria ≥2+ and a 24-hour urinary protein level \\>1.0 g.\n\n   c）Patients with gastrointestinal diseases such as active gastric or duodenal ulcers, ulcerative colitis, or active bleeding from an unresected tumor; or other conditions judged by the investigator as potentially causing gastrointestinal bleeding or perforation.\n\n   d）Patients with evidence or history of a significant bleeding tendency within 3 months prior to enrollment (e.g., bleeding \\>30 mL, hematemesis, melena, hematochezia), hemoptysis (\\>5 mL of fresh blood within 4 weeks), or a thromboembolic event (including stroke and\u002For transient ischemic attack) within the past 12 months.\n\n   e）Patients with clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within 6 months prior to enrollment.\n\n   f）Congestive heart failure of New York Heart Association (NYHA) class \\> II; ventricular arrhythmias requiring medication; or an ECG showing a QTc interval ≥480 milliseconds.\n\n   g）Patients who are unable to take fruquintinib orally.\n2. Triple-negative breast cancer :\n\n   a) Patients who have previously received Pucotenlimab treatment;\n3. Melanoma :\n\n   1. Patients who have previously received Pucotenlimab treatment;\n   2. Patients currently have uncontrolled hypertension,defined as:patients with hypertension that cannot be well controlled with monotherapy(systolic blood pressure≥150 mmHg,or diastolic blood pressure≥100 mmHg);or patients using two or more antihypertensive drugs to control blood pressure;\n   3. Urine routine indicates proteinuria≥2+,and 24-hour urine protein\\>1.0g;\n   4. Significant clinically meaningful cardiovascular diseases,including but not limited to acute myocardial infarction,severe\u002Funstable angina,or coronary artery bypass grafting within 6 months before enrollment;\n   5. Congestive heart failure New York Heart Association(NYHA)classification\\>2;ventricular arrhythmias requiring drug treatment;electrocardiogram(ECG)showing QTc interval≥480 milliseconds.",{"count":20,"type":21},[24],[27,28,29],"2025-11-18",{"date":204,"type":34},"2025-11-21",{"date":206,"type":34},"2025-11-04",{"date":38,"type":21},{"name":40,"class":41},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":42},"100583736","study-to-evaluate-impact-as-support-to-anti-pd1-or-anti-pd1-based-regimen-treatment-in-patients-with-inoperable-locally-advanced-or-metastatic-melanoma-100583736","NCT06880198","Study to Evaluate Impact® as Support to Anti PD1 or Anti PD1 Based Regimen Treatment in Patients With Inoperable Locally Advanced or Metastatic Melanoma","An Interventional, Not Pharmacological Study to Evaluate Impact® as Support to Anti PD1 or Anti PD1 Based Regimen Treatment in Patients With Inoperable Locally Advanced or Metastatic Melanoma","MELA-IMPACT","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Histologically confirmed stage III (unresectable) or stage IV Cutaneous Melanoma;\n3. PD-L1 evaluation and as per standard clinical practice, patients with PD-L1 \\\u003C 1% will be treated with anti PD1 based regimen and patients with PD-L1\\>1% will be treated with anti-PD1 in monotherapy;\n4. Anti-PD1 (Nivolumab) or anti PD1 based regimen (Nivolumab plus Ipilimumab or Nivolumab plus Relatlimab) planned as per standard clinical practice and decision by the treating oncologist; ;\n5. Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria;\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;\n7. Screening laboratory values must meet the following criteria before starting the treatment:\n\n   1. WBCs ≥2000\u002FμL\n   2. Neutrophils ≥1500\u002FμL\n   3. Platelets ≥100 x 10³\u002FμL\n   4. Hemoglobin ≥9.0 g\u002FdL\n   5. Serum creatinine of ≤1.5 times the upper normal limits or creatinine clearance \\>40 mL\u002Fminute\n   6. AST ≤ 3 times the upper normal limits\n   7. ALT ≤ 3 times the upper normal limits\n   8. Total bilirubin ≤1.5 times the upper normal limits (except patients with Gilbert Syndrome who must have total bilirubin \\\u003C3.0 mg\u002FdL)\n8. Prior palliative radiotherapy must have been completed at least 2 weeks prior to study drug administration;\n9. Patients of reproductive potential, must use adequate contraception methods;\n10. Signed written consent form;\n\nExclusion Criteria:\n\n1. Active brain metastases;\n2. Patients with previous malignancies unless a complete remission was achieved at least 2 years prior to study entry;\n3. Patients with prior systemic anticancer therapy for unresectable or metastatic melanoma;\n4. Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy;\n5. Presence of active, known, or suspected autoimmune disease;\n6. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of treatment;\n7. Participation in any interventional drug or medical device study within 30 days prior to treatment start;\n8. Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) or active C hepatitis or active HIV;\n9. History of severe hypersensitivity reactions to other monoclonal antibodies;\n10. Pregnant and breast-feeding women;\n11. Patients of reproductive who refuse to use effective methods of contraception.",{"count":218,"type":21},20,[220],"NA","This is a monocentric, prospective study evaluating the effectiveness in reducing immune-related adverse events, and translational study conducted on 20 patients with inoperable locally advanced or metastatic melanoma.\n\nThe patients will be treated with Oral Impact® administered at the dose of two bricks\u002Fday for 21 days + one brick\u002Fday for 14 days, starting exactly one week before Anti PD-1 treatment (nivolumab) or anti PD1 based regimen therapy (Nivolumab plus Ipilimumab or Nivolumab plus Relatlimab) as per clinical practice.\n\nThe comparison will be done with historical literature data on patients matched by age, sex, disease stage, and therapy dosage, not treated with Impact.",[28,223],"Locally Advanced Melanoma","2025-09-11",{"date":226,"type":34},"2025-09-17",{"date":228,"type":34},"2024-08-01",{"date":230,"type":21},"2027-07",{"name":232,"class":41},"Fondazione Melanoma Onlus",{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":245,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":141},"100596858","anti-pd-1-plus-postbiotic-versus-anti-pd-1-alone-in-locally-advanced-or-metastatic-treatment-nave-cutaneous-melanoma-study-100596858","NCT07050940","Anti PD-1 Plus Postbiotic Versus Anti PD-1 Alone in Locally Advanced or Metastatic, Treatment naïve, Cutaneous Melanoma Study","Anti PD-1 Plus Postbiotic Versus Anti PD-1 Alone in Locally Advanced or Metastatic, Treatment naïve, Cutaneous Melanoma: a Phase II Randomized Study With Correlative Biomarkers' Analysis:","Inclusion Criteria:\n\n* Patients 18 years or older\n* Histologically confirmed, unresectable stage IIIC or IV metastatic melanoma;\n* Eastern Cooperative Oncology Group performance status of 0 or 1;\n* The patient must treatment naïve for metastatic disease\n* Patients who have received anti-PD-1 therapy or anti BRAF\u002FMEK in adjuvant setting and relapsed after 6 months of ending adjuvant therapy are allowed to enter clinical study.\n* Patient has at least one measurable lesion that qualifies as a target lesion based on RECIST 1.1. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are not considered measurable unless there has been demonstrated progression in the lesion.\n* Patient is willing to undergo a pretreatment tumor biopsy or provide qualifying archival tumor tissue. To qualify, archival tissue must have been sampled after last exposure to any systemic anti-neoplastic agent (including TVEC or anti-PD-L1 therapy whichever is last). Patients unable to undergo a biopsy may be enrolled if risk\u002Fbenefit ratio of biopsy is considered unfavorable and\u002For when a biopsy would likely lead to significant delays in care. This decision must be accompanied by supporting documentation from the Investigator and performed in consultation with Medical Monitor. All pretreatment tissue must have been collected no more than 120 days prior to screening.\n* Patient has recovered from the effects of any previous chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy, and\u002For surgery (ie, residual toxicity no worse than Grade 1 \\[Grade 2 treatment-associated peripheral neuropathy and\u002For any grade of alopecia are acceptable assuming all other inclusion criteria are met\\]).\n* Patient who has received prior systemic anti-neoplastic agent(s) must wait at least 5 half-lives or 4 weeks (whichever is shorter) following prior therapy before enrollment into the study, or 4 weeks if the half-life of a given investigational agent is not known.\n* Patient has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 within 5 days before the first dose of study drug and an estimated life expectancy of at least 3 months.\n* Patient has adequate hematologic reserve as evidenced by:\n\nAbsolute neutrophil count (ANC) of ≥1000\u002FμL, Absolute lymphocyte count of\n\n≥500\u002FμL, Platelet count of ≥75,000\u002FμL, and Hemoglobin of ≥9 g\u002FdL (patients may be transfused to this level, if necessary, but transfusion must occur \\>1 week prior to the first dose of study drug).\n\n* Patient has adequate hepatic function as evidenced by aspartate transaminase and alanine transaminase values ≤3 × the upper limit of normal (ULN) and serum total bilirubin values of ≤1.5 × ULN (≤2 × ULN for patients with known Gilbert's syndrome) for the reference laboratory measured within 7 days prior to the first dose of study drug. For patients with documented baseline liver metastasis, the following limits will apply: 5 × ULN for transaminase and 2 × ULN for bilirubin.\n* Patient has adequate renal function as evidenced by a serum creatinine ≤1.5 × the ULN for the reference laboratory or a calculated creatinine clearance of ≥45 mL\u002Fmin by the Cockcroft-Gault Equation measured within 7 days prior to the first dose of study drug.\n* Patient has international normalized ratio (INR) AND\u002FOR prothrombin time (PT) AND activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless the patient is receiving anticoagulant therapy, in which case INR and\u002For PT and aPTT must be within the desired therapeutic range of intended use for such anticoagulants.\n* Patient agrees to abide by the contraceptive requirements detailed in the protocol.\n* Women of childbearing potential (WOCBP) must have a negative pregnancy test (serum or urine) within 3 days before the first dose of study drug (see the protocol for the definition of WOCBP).\n* Life expectancy more than 3 months\n* Presence of instrumentally or clinically measurable or evaluable lesions Informed consent obtained\n\nExclusion Criteria:\n\n* Patients with mucosal or with a primary ocular melanoma\n* Active symptomatic or asymptomatic brain metastases\n* Patients with the following disorders: active, known, or suspected autoimmune disease (except for some non-serious disorders, such as vitiligo and type 1 diabetes mellitus, as specified in the study protocol);\n* Previous malignancies (exceptions skin basocellular or squamocellular carcinoma radically resected, in situ uterine cervix in situ carcinoma radically resected) in the previous 2 years.",{"count":241,"type":21},35,[220],"The association between microbiota and response to ICI-based therapy reflects the ability of bacterial metabolites to upregulate MHC class I APM component expression and\u002For function in cancer cells, leading to their elimination by the host's immune system.\n\nThus, the aim of this project is to evaluate the ability of anti PD-1 combined with postbiotic, that here will be a coadjuvant of a standard immunotherapy to upregulate MHC class I APM component expression and\u002For function in cancer cells compared to anti PD-1 alone in first line advanced melanoma patients.",[28],[246,247],"melanoma stage IIIC or IV","untreated for metastatic disease","2025-07-02",{"date":250,"type":34},"2025-07-03",{"date":252,"type":34},"2025-02-01",{"date":254,"type":21},"2026-08-01",{"name":256,"class":41},"Azienda Ospedaliera di Perugia",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":180,"phases":4,"briefSummary":267,"conditions":268,"keywords":272,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":283,"locationsCount":285},"100576398","observational-study-of-patients-with-advanced-melanoma-skin-cancer-to-assess-if-iopener-melanoma-test-can-predict-response-to-immunotherapy-100576398","NCT06784778","Observational Study of Patients With Advanced Melanoma (Skin Cancer) to Assess if IOpener®-Melanoma Test Can Predict Response to Immunotherapy.","A Prospective, Observational, Multicenter Clinical Performance Study to Evaluate IOpener®-Melanoma Test for Predicting Response to Combination or Mono Immunotherapy in Stage III or IV Cutaneous Melanoma Patients.","COMO","Inclusion Criteria:\n\n* First line treatment for unresectable stage III or IV cutaneous melanoma (according to AJCC version 8) with anti-PD1 monotherapy (nivolumab or pembrolizumab) or anti-PD1 + anti-CTL4A combination therapy (nivolumab and ipilimumab).\n* Anticipated life expectancy exceeding 3 months.\n* Aged 18 years or older and able to provide written informed consent.\n\nPatients who have completed adjuvant treatment with anti-PD1 immunotherapy at least 6 months ago can be included.\n\nExclusion Criteria:\n\n* Prior treatment for irresectable stage III or stage IV melanoma with BRAF\u002FMEK inhibitors.\n* Presence of progressive\u002Fsymptomatic brain metastases at baseline.\n* WHO performance score ≥ 2.\n* Adjuvant treatment with anti-PD1 immunotherapy received within the last 6 months.\n* Patients undergoing experimental treatments or therapies.\n* Presence of any medical or other condition that in the opinion of the investigator(s) would preclude the participation in a clinical study.\n* Unwillingness or inability to comply with study and follow-up procedures.",{"count":266,"type":21},196,"The goal of this observational study is to assess whether the IOpener® melanoma test can assist treating physicians in deciding which therapy is most suitable for patients with skin cancer (advanced cutaneous melanoma). For this purpose it is evaluated how well the IOpener-melanoma test can predict the result of cancer treatment in the treatment groups (standard of care anti-PD1 mono-therapy and standard of care anti-PD1 + anti-CTLA-4 therapy).\n\nParticipants will be asked to provide blood sample for analysis using IOpener®-melanoma test. Patients will receive regular medical care, the test results will not be used to make any treatment decisions. The patients will visit the clinic for treatment administration and clinical evaluation as part of their regular medical care.",[28,269,270,271],"Melanoma, Skin","Melanoma Stage III or IV","Melanoma Advanced",[273,274,275,276],"melanoma","IOpener","immunotherapy","immune checkpoint inhibitor","2025-02-25",{"date":279,"type":34},"2025-02-28",{"date":281,"type":34},"2024-07-12",{"date":230,"type":21},{"name":284,"class":168},"Pamgene International B.V.",3,{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":177,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":294,"briefSummary":295,"conditions":296,"keywords":297,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":42},"100576282","phase-1-t-cell-therapy-with-crispr-pd1-edited-tumor-infiltrating-lymphocytes-for-patients-with-metastatic-melanoma-100576282","NCT06783270","T-cell Therapy with CRISPR PD1-edited Tumor Infiltrating Lymphocytes for Patients with Metastatic Melanoma","CRISPR-TIL","Inclusion Criteria:\n\n1. Histologically confirmed inoperable or metastatic melanoma (stage IIIc or IV).\n2. Progressive disease after standard treatment with anti-PD-1 check-point inhibition or combination of aforementioned with anti-CTLA-4 check-point inhibition.\n3. Age: 18 - 75 years at the time of signed Informed consent.\n4. ECOG performance status of ≤1 (Appendix 2).\n5. Is fit for tumor resection and has at least one lesion (\\> 1 cm3) available for surgical resection for manufacture of TIL. (Unless TILs are already available through metastasectomy prior to enrollment in this study, as described in step one under study design)\n6. At least one measurable parameter in accordance with RECIST 1.1 -criteria (excluding the lesion to be resected).\n7. LVEF assessment with documented LVEF ≥50% by either TTE or MUGA.\n8. Sufficient organ function, including:\n\n   * Absolute neutrophil count (ANC) ≥ 1.500 \u002Fμl\n   * Leucocyte count ≥ lower normal limit\n   * Platelets ≥ 100.000 \u002Fμl and \\\u003C700.000 \u002Fμl\n   * Hemoglobin ≥ 6.0 mmol\u002Fl\n   * eGFR \\> 70\n   * S-bilirubin ≤ 1.5 times upper normal limit (Exception: Subjects with liver metastasis ≤ 2.5 × ULN)\n   * ASAT\u002FALAT ≤ 2.5 times upper normal limit (Exception: Subjects with liver metastasis ≤ 5.0 × ULN)\n   * Alkaline phosphatase ≤ 5 times upper normal limit\n   * Lactate dehydrogenase ≤ 5 times the upper normal limit\n   * Sufficient coagulation: APPT\\\u003C40 and INR\\\u003C1.5\n9. Signed statement of consent after receiving oral and written study information\n10. Willingness to participate in the planned controls and capable of handling toxicities.\n11. Subject must receive CRISPR-TIL as the next therapy following tumor resection unless bridging therapy is administered:\n\n    * Bridging therapy is discouraged. However, if in the opinion of the Investigator, the subject requires immediate therapy after tumor resection, the subject may receive bridging therapy for the period during which the subject is awaiting the manufacture of TIL-infusion product. Bridging therapy may be a continuation of the therapy the subject was receiving prior to tumor resection or may be a new therapy.\n    * Following this bridging therapy, the subject must adhere to the mandatory washout periods (described in exclusion criterion 1) and must continue to have measurable disease prior to receiving CRISPR-TIL.\n12. Age and Reproductive Status:\n\n    * Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test AND must agree to use an effective method of contraception starting at the first dose of chemotherapy for at least 12. WOCB must also agree to refrain from egg donation, storage, or banking during these same time periods. The following are considered safe methods of contraception:\n\n      * Hormonal anticonception (birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring, and transdermal depot patch)\n      * Intrauterine device\n      * Surgical sterilization\n      * Surgical sterilization of male partner with verification of no sperm after the procedure\n      * Menopause (for more than 12 months)\n    * Male subjects must be surgically sterile or agree to use a double-barrier contraception method or abstain from sexual activity with an WOCBP starting at the first dose of chemotherapy and for 6 months thereafter. Male subjects must also agree to refrain from sperm donation, storage, or banking.\n\nExclusion Criteria:\n\n1. Subject has received or plans to receive the following therapy\u002Ftreatment prior to tumor resection (TR) or lymphodepleting chemotherapy (LDC):\n\n   * Cytotoxic chemotherapy: Washout period 3 weeks before TR and LDC.\n   * Small molecules\u002FTKI: Washout period 1 week before TR and LDC.\n   * Immune therapy (monoclonal AB therapy, CPI, and biologics): 2 weeks before TR and LDC\n   * Prior T-cell therapy, including gene therapy using an integrating vector.\n   * Corticosteroids at dose equivalent \\> 10 mg prednisone or any other immunosuppressive therapy. 2 weeks before TR and LDC. Note: Use of topical steroids is not an exclusion.\n   * Investigational treatment: 4 weeks or 5 half-lives, whichever is shorter before TR and LDC.\n   * Radiation to the pelvis and\u002For multiple bones containing ≥ 25% of bone marrow: 4 weeks before TR and LDC.\n   * Whole brain radiotherapy or brain stereotactic radiosurgery: 4 weeks before TR and LDC.\n   * Radiotherapy to the target lesions: 3 months prior to TIL infusion. A lesion with unequivocal progression post-radiotherapy may be considered a target lesion.\n2. A history of prior malignancies. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 2 years after treatment. Subjects with curatively treated ductal carcinoma in situ (DCIS or LCIS) breast cancer for which they are taking hormonal therapy is acceptable. Resectable squamous or basal cell carcinoma of the skin is acceptable.\n3. Patients with metastatic ocular\u002Fmucosal or other non-cutaneous melanoma. Unknown primary melanoma is eligible.\n4. Toxicity from previous anti-cancer therapy must have resolved to ≤ Grade 1 or baseline prior to enrollment (except for non-clinically significant toxicities e.g., alopecia, vitiligo). Subjects with Grade 2 toxicities who are deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.\n5. Patients who have more than 2 CNS metastases or who have any CNS lesion that is symptomatic, greater than 1 cm in diameter, or show significant surrounding edema on MRI scan will not be eligible until they have been treated and demonstrated no clinical or radiologic CNS progression for at least 2 months.\n6. The following patients will be excluded because of their inability to receive high-dose interleukin-2 (See appendix 5):\n\n   * History of coronary revascularization\n   * Documented LVEF of less than 45% in patients with clinically significant atrial and\u002For ventricular arrhythmias including but not limited to atrial fibrillation, ventricular tachycardia, 2o or 3o heart block\n   * Documented FEV-1 less than or equal to 60% predicted value for patients with: A prolonged history of cigarette smoking (greater than 20 pack years), large tumor burden in the lungs, or Symptoms of respiratory distress.\n7. Known hypersensitivity to one of the active drugs or one or more of the excipients.\n8. Severe medical conditions, such as severe asthma\u002FCOLD, significant cardiac disease, and poorly regulated insulin-dependent diabetes mellitus among others.\n9. Creatinine clearance (eGFR) \\\u003C 70 ml\u002Fmin\\*.\n10. Acute\u002Fchronic infection with HIV, hepatitis, and syphilis among others.\n11. Severe allergies or previous anaphylactic reactions.\n12. Active autoimmune or immune-mediated disease that has not yet resolved. Subjects with the following will be eligible:\n\n    * Immune-mediated AEs secondary to immunotherapy which have resolved to ≤ Grade 1 without steroids;\n    * Hypothyroidism, Type I diabetes, adrenal insufficiency, or pituitary insufficiency that are stable on replacement therapy;\n    * Disorders such as asthma, vitiligo, psoriasis, or atopic dermatitis that are well-controlled without requiring systemic immunosuppression;\n    * Other stable immune conditions that do not require prednisone higher than 10 mg\u002Fday or their equivalent dose for other corticosteroid agents may be acceptable with the agreement of the Sponsor.\n13. Pregnant women and women breastfeeding.\n14. Subjects deemed unlikely to fully comply with protocol requirements by the study investigator.\n\n    * In selected cases it can be decided to include a patient with a eGFR \\\u003C 70 ml\u002Fmin with the use of a reduced dose of chemotherapy.",{"count":53,"type":21},[87],"The purpose of this study is to assess wether it is safe and feasible to treat patients with tumor infiltrating lymphocytes that have been silenced for PD-1, using CRISPR-Cas9.",[28],[298,299],"TIL-therapy","TIL-ACT","2025-01-14",{"date":302,"type":34},"2025-01-20",{"date":304,"type":34},"2024-12-16",{"date":306,"type":21},"2028-01-01",{"name":308,"class":41},"Inge Marie Svane",{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":180,"phases":4,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":85},"100561164","neoadjuvant-immunotherapy-of-operable-metastatic-melanoma-in-real-life-gcc-100561164","NCT06586593","Neoadjuvant Immunotherapy of Operable Metastatic Melanoma in Real Life (GCC)","ETUDE NEOMEL: TRAITEMENT NEOADJUVANT PAR IMMUNOTHERAPIE DU MELANOME METASTATIQUE OPERABLE EN VIE REELLE (GCC)","NEOMEL","Inclusion Criteria:\n\n* Patients with operable metastatic melanoma (stage III or IV of American Joint Committee on Cancer \\[AJCC\\] Stages CLassification) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4), even if surgery cancelled due to disease progression or complete response or patient\\'s refusal to be operated.\n* Efficacy of the neoadjuvant immunotherapy histologically of radiologically assessed\n\nExclusion Criteria:\n\n* Uveal melanoma",{"count":318,"type":21},77,"This study aims to evaluate efficacy and tolerance of real life neoadjuvant immunotherapy in advanced yet operable melanoma.\n\nThe complete histological response will be assessed.",[28],"2024-09-06",{"date":323,"type":34},"2024-09-19",{"date":325,"type":34},"2023-03-24",{"date":327,"type":21},"2025-01",{"name":329,"class":41},"Centre Hospitalier Universitaire de Besancon"]