[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mucosal-melanoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mucosal-melanoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,43,76,105,132,169,196,222,245,272,360],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"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},"100540619","phase-2-clear-me-interception-trial-to-detect-and-clear-molecular-residual-disease-in-patients-with-high-risk-melanoma-100540619",false,"NCT06319196","Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma","Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High Risk Melanoma","ClearMe","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of screening or age of consent according to law.\n2. Written informed consent and any locally required authorization (e.g., data privacy) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Must have a life expectancy of at least 12 weeks.\n5. Histologically confirmed cutaneous or mucosal melanoma.\n6. High risk melanoma subjects with disease staging for which adjuvant immunotherapy has been proven to reduce the risk of relapse versus observation (disease stage: 2B, 2C, 3A, 3B, 3C, 3D, 4 fully resected).\n7. Archival tumor formalin-fixed, paraffin-embedded (FFPE) specimens for correlative biomarker studies are required (1 H\\&E and 10 unstained 5 microns slides). If surgery is going to be performed after signing consent, then tumor FFPE from that surgery is allowed.\n8. Patient is a candidate for definitive treatment: including surgery, and post-operative adjuvant immunotherapy with or without radiation for local control.\n9. No detectable disease via imaging (CT scan, MRI, with or without Positron emission tomography (PET) CT scan). Table 4.1.2-1 : Criteria for adequate organ and Marrow function\n10. Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception (see Section 8.1.1 for definition of females of childbearing potential and for a description of highly effective methods of contraception) from screening to 180 days after the final dose of study treatment. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.\n11. Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from screening to 180 days after receipt of the final dose of study treatment. It is strongly recommended for the female partner of a male subject to also use a highly effective method of contraception throughout this period, as described in Section 8.1.2. In addition, male subjects must refrain from sperm donation while on study and for 180 days after the final dose of study treatment.\n\nExclusion Criteria:\n\n1. Diagnosis of uveal melanoma.\n2. Any prior systemic anticancer therapy for melanoma. Any concurrent anticancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is allowed.\n3. Evidence of metastatic disease at surgical and radiological staging.\n4. History of allogeneic organ transplantation.\n5. History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to anti-PD-1 or anti-LAG-3 or any of their excipients.\n6. History of active primary immunodeficiency.\n7. Active autoimmune or inflammatory disorders (including inflammatory bowel disease \\[eg, colitis or Crohn's disease\\], immune related diverticulitis \\[prior diverticulitis in the context of diverticulosis is allowed provided is not active\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\].\n\n   The following are exceptions to this criterion:\n   1. Participants with vitiligo or alopecia\n   2. Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement\n   3. Any chronic skin condition that does not require systemic therapy. Participants without active disease in the last 1 year may be included but only after consultation with the Principal Investigator\n   4. Participants with celiac disease controlled by diet alone\n8. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive Hepatitis B virus (HBV) surface antigen \\[HBsAg\\] result), or hepatitis C (HCV). Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Subjects with well-controlled Human Immunodeficiency Virus (HIV) are allowed.\n9. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, clinically relevant coronary artery disease or history of myocardial infarction in the last 4 months or high risk of uncontrolled arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the participant to give written informed consent.\n10. History of another primary malignancy except for:\n\n    1. Malignancy treated with curative intent and with no known active disease ≥ 3 years before the first dose of study treatment and of low potential risk for recurrence.\n    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n    3. Adequately treated carcinoma in situ without evidence of disease.\n    4. Participants with a history of prostate cancer (tumor\u002Fnode\u002Fmetastasis stage) of Stage ≤ T2cN0M0 without biochemical recurrence or progression and who in the opinion of the investigator are not deemed to require active intervention\n11. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 500 msecs calculated from three ECGs.\n12. Prior nivolumab or relatlimab therapy.\n13. Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention. The following are exceptions to this criterion (see Section 4.7.1.1):\n\n    1. Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)\n    2. Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n    3. Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)\n14. Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Participants should not receive live vaccine whilst receiving study intervention and up to 30 days after the last dose of study intervention. Should the participants be deemed candidates for the Monkey pox vaccine, the case will need to be discussed with the coordinating Principal Investigator.\n15. Participation in another clinical study with an investigational product administered in the last 28 days prior to randomization or concurrent enrollment in another clinical study, unless the study is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n16. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.\n17. For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.\n18. Subjects who are unable to willingly provide consent or are unable to comply with the protocol procedures.","ALL","18 Years",{"count":20,"type":21},54,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Clear-Me is a biomarker-driven phase II study that tests whether the combination anti- lymphocyte-activation gene-3 (LAG3)\u002Fanti-programmed cell death protein 1(PD-1) inhibition Bristol-Myers Squibb (BMS986213) is superior to anti-PD-1 inhibition in patients with detectable circulating tumor deoxyribonucleic acid (ctDNA) following definitive surgery for high risk melanoma. Patients will be allocated to either Arm A or Arm B via the process of randomization. The randomization process will be stratified according to stage (Stage 2A\u002F2B\u002F3A\u002F3B\u002F3C\u002F3D or 4), to ensure absolute balance between stage groups. The investigators are choosing only 1 stratification factor, disease stage, as the investigators consider stage being the most significant prognosticating variable. Each stage represents a biologically distinct entity with varying recurrence rate outcomes. Block randomization will be performed to ensure equal sample sizes in the combination and monotherapy arms. At least 54 patients will be included in the randomized part of the study. The investigators are expecting approximately 20% of the patients to have detectable ctDNA after definite surgery. Therefore, approximately 270 patients are expected to be enrolled and tested for ctDNA in the entire study.",[27,28,29],"Cutaneous Melanoma","Melanoma Stage IV","Mucosal Melanoma","RECRUITING","2026-06-02",{"date":33,"type":34},"2026-06-04","ACTUAL",{"date":36,"type":21},"2026-08-27",{"date":38,"type":21},"2030-02-15",{"name":40,"class":41},"University Health Network, Toronto","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100640027","phase-1-a-first-in-human-study-to-evaluate-the-safety-pharmacokinetics-and-pharmacodynamics-of-kup-101a-in-patients-with-selected-advanced-solid-tumors-100640027","NCT07600476","A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed cancer with evidence of advanced disease for which no other standard treatment is available\n* ECOG Performance status of 0 to 2\n* Adequate hematological, renal, and hepatic organ function\n\nExclusion Criteria:\n\n* Previous systemic treatment with TLR agonists, with the exception of TLR agonists used as vaccine adjuvants.\n* Known additional malignancy that is progressing or requires active treatment\n* Diagnosis of immunodeficiency\n* Active autoimmune disease not caused by prior anticancer treatment that required systemic immunosuppressive treatment in the past 2 years\n* Active autoimmune disease caused by prior anticancer treatment, unless currently controlled by replacement therapy only.\n* Any kind of leukemia\n* Previously received an organ transplant (other than corneal transplants) or hematopoietic stem cell transplantation\n* Known active central nervous system metastases and\u002For carcinomatous meningitis\n* Cerebral vascular event within 6 months before Screening\n* Unstable cardiopulmonary status defined by uncontrolled congestive heart failure of New York Heart Association Grade III or IV, unstable angina, or myocardial infarction within 6 months before Screening\n* High grade ocular disease such as uncontrolled glaucoma",{"count":50,"type":21},21,[52],"PHASE1","The purpose of this trial is to find the maximum tolerated and recommended Phase 2 dose of KUP-101A and to evaluate its safety and tolerability. Additionally, pharmacokinetics and pharmacodynamics will be assessed, and first data on KUP-101A's efficacy in patients with advanced solid tumors will be obtained.",[27,29,55,56,57],"Cutaneous Squamous Cell Carcinoma (CSCC)","Merkel Cell Carcinoma of Skin","Basal Cell Carcinoma of Skin",[59,60,61,62,63,64],"TLR4 agonist","TLR7 agonist","TLR4\u002F7 agonist","skin cancer","innate immunity","immunotherapy","2026-05-13",{"date":67,"type":34},"2026-05-20",{"date":69,"type":21},"2026-04",{"date":71,"type":21},"2028-12",{"name":73,"class":74},"Kupando GmbH","INDUSTRY",2,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"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":84,"type":21},50,[52],"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",[88,89,29],"Melanoma Metastatic","Uveal Melanoma, Metastatic",[91,92,93,94],"Metastatic Melanoma","Melanoma","Radiopharmaceuticals","Theranostic","2026-03-12",{"date":97,"type":34},"2026-03-16",{"date":99,"type":34},"2025-11-19",{"date":101,"type":21},"2028-01",{"name":103,"class":74},"Alpha-9 Oncology USA Inc.",4,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":42},"100592941","phase-2-neo-irenie-neoadjuvant-ipilimumab-relatlimab-nivolumab-evaluation-100592941","NCT06999980","Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)","A Phase II, Multicentre, Parallel Group, Open Label, Randomised Clinical Trial of Neoadjuvant Nivolumab and Ipilimumab Combined With Relatlimab for Patients With Resectable Advanced Melanoma Identified as Poor Responders to Immunotherapy","Neo IRENIE","COMMON Inclusion Criteria Applicable to all 3 cohorts\n\nInclusion Criteria:\n\n* 1\\. Written informed consent\n* 2\\. Male or female patients who are at least 18 years of age on the day of signing informed consent.\n* 3\\. Clinically detectable disease, and\u002For RECIST version 1.1 defined disease, and\u002For disease confirmed on PET imaging.\n* 4\\. Fully resectable disease defined as having no significant vascular, central nervous system or bony involvement. Only cases where a complete surgical resection leading to tumour free margins and which is safely achieved is considered \"resectable\".\n* 5\\. Concurrent primary disease and lymph node metastases acceptable provided completely resectable.\n* 6\\. Up to 3 in-transit metastases are permitted as long as these are fully resectable.\n* 7\\. Tumour that is amenable to a newly obtained core biopsy for performance of the multi-omic predictive biomarker model\n* 8\\. ECOG performance status of 0 to 1.\n* 9\\. Adequate haematological, hepatic, renal and endocrine function\n* 10\\. An anticipated life expectancy of \\>12 months.\n* 11\\. Women of child bearing potential (WOCBP) must agree to avoid pregnancy or breast feeding for the duration of study treatment.\n\nInclusion Criteria - Cohort 1 only\n\n* a. Histologically confirmed diagnosis of cutaneous melanoma or unknown primary melanoma\n* b. AJCC 8th Ed Stage IIIB, IIIC, IIID cutaneous melanoma\n* c. No prior systemic treatment for cutaneous melanoma\n* d. Completion of the multi-omic predictive biomarker model within 14 days (7-10 business days) of planned randomisation.\n\nInclusion Criteria - Cohort 2 only\n\n* a. Histologically confirmed diagnosis of cutaneous melanoma or unknown primary melanoma\n* b. AJCC 8th Ed Stage IIIB, IIIC, IIID cutaneous melanoma\n* c. Disease progression on neoadjuvant anti-PD-1 monotherapy, where progressed disease is completely resectable or, disease recurrence on adjuvant anti-PD-1 monotherapy, where recurrent disease is completely resectable\n* d. No prior treatment with CTLA-4 or LAG-3 inhibitors.\n\nInclusion Criteria - Cohort 3 only\n\n* a. Histologically confirmed diagnosis of mucosal melanoma\n* b. Any stage of disease provided it is fully resectable\n* c. No prior systemic treatment for mucosal melanoma\n\nCOMMON Exclusion Criteria Applicable to all 3 cohorts\n\n* 1\\. Uveal melanoma\n* 2\\. Any contraindication to the administration of relatlimab, ipilimumab or nivolumab\n* 3\\. No prior systemic therapy, including treatment with prior anti-PD1\u002FL1, anti-CTLA-4 or anti-LAG-3 therapy (cohorts 1 and 3), except for cohort 2 which will have received anti-PD1 monotherapy only.\n* 4\\. A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days of randomisation. The following are permitted:\n\n  1. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc)\n  2. Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient is on a stable dose\n  3. Non-absorbed intra-articular steroid injections.\n* 5\\. An active autoimmune disease that has required systemic treatment in the past 12 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). The following are permitted:\n\n  1. Vitiligo\n  2. Type I diabetes mellitus\n  3. Residual autoimmune hypothyroidism on stable hormone replacement\n  4. Resolved childhood asthma or atopy\n  5. Psoriasis not requiring systemic treatment\n  6. Autoimmune conditions which are not expected to recur in the absence of an external trigger.\n* 6\\. A known additional malignancy that is progressing or has required active treatment within the past 3 years. The following malignancies, if undergone successful definitive resection or curative treatment, are permitted:\n\n  1. Basal cell carcinoma of the skin\n  2. Squamous cell carcinoma of the skin\n  3. Carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy)\n  4. Prostatic intraepithelial neoplasia\n  5. In situ melanoma\n  6. Atypical melanocytic hyperplasia\n  7. Multiple primary melanomas\n  8. Other malignancies for which the patient has been disease free for 1 year.\n* 7\\. A known CNS metastases and\u002For carcinomatous meningitis\n* 8\\. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis or current interstitial lung disease.\n* 9\\. Has an active infection requiring systemic therapy.\n* 10\\. Has a known history of Human Immunodeficiency Virus (HIV). Note: no testing for HIV is required unless mandated by local health authority.\n* 11\\. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* 12\\. Has a known history of active TB (Bacillus Tuberculosis).\n* 13\\. Uncontrolled or significant cardiovascular disease including, but not limited to any of the following:\n\n  1. Myocardial infarction (MI) or stroke\u002Ftransient ischemic attack within the 6 months prior to consent\n  2. Uncontrolled angina within the 3 months prior to consent\n  3. Any history of clinically significant arrhythmias (such as poorly controlled atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or torsades de pointes)\n  4. QTc prolongation \\> 480 ms\n  5. History of other clinically significant cardiovascular disease (i.e. cardiomyopathy, congestive heart failure with New York Heart Association functional classification III-IV, pericarditis, significant pericardial effusion, significant coronary stent occlusion, poorly controlled venous thrombosis, etc)\n  6. Cardiovascular disease-related requirement for daily supplemental oxygen\n  7. History of 2 or more M.I.s OR 2 or more coronary revascularisation procedures (regardless of the number of stent placements during each procedure)\n  8. Patients with history of myocarditis, regardless of aetiology.\n* 14\\. Patients with a \\>1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \\\u003C1 g\u002F24 hours.\n* 15\\. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n* 16\\. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* 17\\. Pregnant or breast feeding females\n* 18\\. Concurrent medical or social conditions that may prevent the patient from attending assessments per schedule",{"count":114,"type":21},494,[24],"This clinical trial is for patients with stage 3 cutaneous melanoma and patients with mucosal melanoma who are able to have surgery to remove all tumour deposits. To improve the chance that melanoma will not recurr, new experimental combinations of a type of treatment called immunotherapy will be given before surgery.",[27,29],[119,120,121,122],"Neoadjuvant","Immunotherapy","Randomised trial","Low Responder","2026-02-18",{"date":125,"type":34},"2026-02-19",{"date":127,"type":34},"2026-02-09",{"date":129,"type":21},"2038-01",{"name":131,"class":41},"Melanoma Institute Australia",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":75},"100468800","phase-2-axitinib-and-nivolumab-for-the-treatment-of-mucosal-melanoma-100468800","NCT05384496","Axitinib and Nivolumab for the Treatment of Mucosal Melanoma","Phase 2 Study of Axitinib + PD-1 Blockade in Mucosal Melanoma With Pilot Addition of Stereotactic Body Radiotherapy or Ipilimumab in Select Progressors","Inclusion Criteria:\n\n* Histologic diagnosis of unresectable or advanced mucosal melanoma arising from the head\u002Fneck (e.g. sinonasal, oral cavity, conjunctival), gastrointestinal (e.g. anorectal, esophageal), or genitourinary (e.g. vulvovaginal, urethral) sites.\n* Measurable disease\n\n  1. Initial study entry: Subjects must have at least 1 extracranial, unresectable, non-bony lesion that is measurable radiographically (based on RECIST 1.1).\n  2. Triplet arms: assessable disease required. RECIST 1.1 measurable disease is not required.\n* Prior therapy\n\n  1. Initial study entry: No prior systemic therapy (adjuvant or metastatic).\n  2. Triplet arms: Only prior systemic therapy is nivolumab + axitinib on this trial.\n* ECOG performance status of 0-2.\n* Asymptomatic untreated brain metastases are allowed. Symptomatic brain metastases that have undergone local therapy with RT or surgery and have not required an increase in steroid dose in prior 2 weeks are allowed.\n* Screening laboratory parameters:\n\n  1. White blood cell (WBC) count ≥ 2000\u002FμL;\n  2. Absolute neutrophil count (ANC) ≥ 1500\u002FμL;\n  3. Platelets ≥ 100,000\u002FμL;\n  4. Hemoglobin (Hgb) ≥ 9 g\u002FdL;\n  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN);\n  6. Total bilirubin ≤ 1.5 × ULN (\\\u003C 3 mg\u002FdL for subjects with Gilbert's disease);\n  7. Estimated glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin;either Cockcroft Gault or a cancer-specific GFR Model such as the camGFR version 2 can be used;\n* Age ≥ 18 years.\n* Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 23 weeks after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. \\[Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).\\] Nonsterilized males who are sexually active with a female partner of childbearing potential must use 2 acceptable methods of effective contraception from Day 1 and for 31 weeks after receipt of the final dose of investigational product.\n\nAcceptable methods of effective contraception are described in the following:\n\n* Barrier Methods (Male condom plus spermicide, cap plus spermicide, or diaphragm plus spermicide).\n* Intrauterine Device Methods (Copper T, or Levonorgestrelreleasing intrauterine system (e.g., Mirena®), also considered a hormonal method).\n* Hormonal Methods (Implants, hormone shot or injection, combined pill, mini pill, or Patch).\n\nExclusion Criteria:\n\n* Active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (\\>10 mg daily of prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* History of motor neuropathy considered to be of autoimmune origin (e.g., Guillain- Barre Syndrome, Myasthenia Gravis).\n* History of myocarditis.\n* History of, or any active evidence of non-infectious pneumonitis\n* Other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator.\n* Cardiovascular disease, including:\n\n  * History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary artery bypass graft (CABG) coronary angioplasty, or stenting within 6 months prior to study entry.\n  * Current Class II or higher congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system.\n  * Treatment-refractory hypertension defined as a blood pressure of systolic \\>150 mmHg and\u002For diastolic \\>90 mmHg despite adequate attempts at antihypertensive therapy.\n* Underlying hematologic issues including:\n\n  * Congenital bleeding diathesis\n  * GI bleeding requiring intervention within the past 6 months\n  * Active hemoptysis within 42 days prior to study enrollment\n  * Pulmonary emboli or deep vein thromboses (DVT) that are not stable on anticoagulation regimen.\n* History of severe allergic reactions to an unknown allergen or any components of the study drugs.\n* Other serious infectious illnesses (e.g., active symptoms of COVID-19 infection or a post-infectious symptomatic autoimmune syndrome, serious bacterial infections requiring antibiotics).\n* Women who are breastfeeding or who are pregnant as evidenced by a positive serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) performed within 14 days of the first dose of study drug and by a urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 24 hours of the first dose of study drug(s).\n* Genetic or autoimmune condition causing heightened radio sensitivity.",{"count":140,"type":21},20,[24],"The researchers are doing this study to find out whether the combination of axitinib and nivolumab is an effective and safe treatment for people with advanced or metastatic mucosal melanoma that has not been treated before.\n\nThe researchers think that a combination of axitinib and nivolumab may help people with this disease because both drugs target and block proteins that play a role in cancer cell survival and growth. The researchers think the drugs may be more effective if given in combination rather than on their own.",[29],[145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160],"Axitinib","Nivolumab","PD-1 Blockade","Stereotactic Body Radiotherapy","Ipilimumab","22-017","head\u002Fneck","sinonasal","oral cavity","conjunctival","gastrointestinal","anorectal","esophageal","genitourinary","vulvovaginal","urethral","2026-02-16",{"date":123,"type":34},{"date":164,"type":34},"2022-05-17",{"date":166,"type":21},"2027-05",{"name":168,"class":41},"Memorial Sloan Kettering Cancer Center",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":42},"100610671","phase-2-neo-adjuvant-immunotherapy-in-patients-with-localized-melanoma-100610671","NCT07230613","Neo-adjuvant Immunotherapy in Patients With Localized Melanoma","Neo-adjuvant Intratumoral Anti-CTLA4 + Anti-PD1 in Patients With Localized Melanoma","NEOREM-NEO-1","In addition to NEOREM Master Protocol inclusion and exclusion criteria, the following inclusion and exclusion criteria must be verified before inclusion in the NEO-1 trial:\n\nInclusion Criteria:\n\n1. Patients ≥ 18 years old.\n2. Patients with resectable and measurable (according to RECIST v1.1 criteria) stage III cutaneous and mucosal melanoma.\n3. Patients who received anti-PD-1 and stopped treatment \\> 6 months prior to their inclusion in NEO-1 trial are eligible.\n4. Patients who received target therapy and stopped treatment \\> 3 months prior to their inclusion in NEO-1 trial are eligible.\n\nExclusion Criteria:\n\n1. Patients with clinically or radiologically detectable distant metastases.\n2. Patients with uveal melanoma.\n3. Patients with any hypersensitivity to the active ingredient or to any of the excipients of nivolumab and\u002F ipilimumab.\n4. Patients without pathological evaluable disease according to RECIST v1.1 criteria.",{"count":84,"type":21},[24],"The success of anti-PD-1 and anti-CTLA-4 therapies has initiated a paradigm shift in oncology, with drugs now targeting the immune system rather than cancer cells to stimulate the antitumor immune response. Intratumoral (IT) delivery of immunostimulating agents reduces the systemic toxicity associated with monoclonal antibodies (mAbs) targeting immune checkpoints. Notably, IT injections of immune checkpoint blockade (ICB) have been shown to induce immune-mediated tumor responses both at the injected site and at distant, non-injected tumor sites. While surgery has traditionally been the preferred treatment for stage III and IV melanoma patients, neoadjuvant therapy with anti-CTLA-4 and anti-PD-1 agents has shown promising efficacy.\n\nIn patients with localized melanoma, it is hypothesized that IT administration of ipilimumab (anti-CTLA-4 Ab) combined with nivolumab (anti-PD-1 Ab) will provide the most effective and safe treatment combination.\n\nThe NEO-1 study is a proof-of-concept clinical trial designed as a sub-protocol of NEOREM master protocol (NCT07262489) to validate the intratumoral immunotherapy approach, aiming to maximize the dose\u002Fefficacy ratio of combined ipilimumab and nivolumab treatment while minimizing systemic adverse events. This is an academic, open-label, multicentric, phase II clinical trial evaluating the efficacy and safety of intratumoral injections of ipilimumab and nivolumab combination as neoadjuvant treatment in localized stage III resectable cutaneous or mucosal melanoma patients.\n\nBaseline and on-treatment PORTRAIT profiling, as described in the NEOREM Master Protocol (NCT07262489), will be performed using fresh blood and tumor samples. This profiling will reveal the immune status of patients and support biomarker-driven preselection for future trials.",[181,29],"Cutaneous Melanoma, Stage III",[183,184,185,92,186],"Neo-adjuvant Immunotherapy","Localized Cancers","Intra-tumoral treatment","Immune-checkpoint blockade","2026-02-06",{"date":189,"type":34},"2026-02-11",{"date":191,"type":34},"2026-01-12",{"date":193,"type":21},"2033-12",{"name":195,"class":41},"UNICANCER",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":42},"100623720","phase-2-sintilimab-combined-with-chemotherapy-for-adjuvant-treatment-of-mucosal-melanoma-after-surgery-100623720","NCT07400302","Sintilimab Combined With Chemotherapy for Adjuvant Treatment of Mucosal Melanoma After Surgery","A Randomized, Controlled, Multicenter Phase II Clinical Study Evaluating the Adjuvant Treatment of PD-L1-Positive, Resectable Mucosal Melanoma With Sintilimab Plus Chemotherapy Versus Chemotherapy Alone","Inclusion Criteria:\n\n1. Sign a written informed consent form (Informed Consent, ICF) and be able to comply with the visit schedule and related procedures outlined in the protocol.\n2. Histologically\u002Fcytologically confirmed mucosal melanoma, with primary and\u002For metastatic lesions completely resected, with negative surgical margins.\n3. Tissue specimen: PD-L1 positive (CPS ≥ 1).\n4. The first dose of the study drug must be administered only after the melanoma resection wound has fully healed, and the injection time must not exceed 13 weeks post-surgery (if the time limit is exceeded by no more than 7 days due to unforeseen circumstances, the decision to enroll may be discussed with the medical monitor).\n5. Confirmed R0 complete resection by physical examination and imaging within 4 weeks prior to randomization.\n6. For central nervous system (CNS) metastasis, post-surgical resection may receive adjuvant radiotherapy as needed. MRI of the brain must show no recurrence for at least 4 weeks after surgery or surgery combined with radiotherapy. Note: if immunosuppressants (e.g., prednisone) are required, they must be discontinued at least 14 days before the study drug administration.\n7. If lymph node dissection combined with local radiotherapy is required after melanoma resection, radiotherapy must be completed within 13 weeks of lymph node dissection and before the start of adjuvant treatment. Note: If delayed wound healing occurs due to radiotherapy, the subject will not meet the eligibility criteria.\n8. Age ≥ 18 years.\n9. Expected survival ≥ 12 weeks.\n10. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.\n11. Sufficient organ and bone marrow function, with laboratory values meeting the following criteria within 7 days before enrollment (no blood components, cell growth factors, albumin, or other intravenous or subcutaneous corrective drugs should be given within 14 days prior to laboratory tests):\n\n(1) Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet Count (PLT) ≥ 90 × 10⁹\u002FL; Hemoglobin (HGB) ≥ 9.0 g\u002FdL (90 g\u002FL).\n\n(2) Liver Function: Total Bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN) (for patients suspected of or diagnosed with Gilbert's syndrome, TBIL ≤ 3 × ULN); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN.\n\n(3) Renal Function: Serum Creatinine (Scr) ≤ 1.5 × ULN, or Creatinine Clearance Rate (Ccr) ≥ 50 ml\u002Fmin (calculated using the Cockcroft\u002FGault formula), and urinalysis showing urinary protein (UPRO) \\\u003C 2+ or 24-hour urinary protein \\\u003C 1g.(Cockcroft-Gault Formula) (4) Coagulation Function: International Normalized Ratio (INR) and Prothrombin Time (PT) ≤ 1.5 × ULN.\n\n12\\. Female subjects of childbearing potential, or male subjects whose partners are women of childbearing potential, must use effective contraception throughout the treatment period and for 6 months after treatment.\n\nExclusion Criteria:\n\n1. Previous exposure to any anti-PD-1 or anti-PD-L1\u002F2 antibody.\n2. Previous use of interferon.\n3. Hyperthyroidism or hypothyroidism. Note: Hypothyroid patients whose condition is stable after hormone replacement therapy may be included.\n4. Concurrent participation in another clinical trial.\n5. Receipt of any investigational drug within 4 weeks before the first dose of the study drug.\n6. Use of immunosuppressive drugs within 4 weeks prior to the first dose of the study drug, excluding nasal, inhaled, or other topical corticosteroids or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids).\n7. Receipt of live attenuated vaccines within 4 weeks before the first dose of the study drug or planned use during the study.\n8. Major surgery (e.g., craniotomy, thoracotomy, or laparotomy) or any unhealed wounds, ulcers, or fractures within 4 weeks before the first dose of the study drug.\n9. History of gastrointestinal perforation and\u002For fistulas within 6 months prior to the first dose of the study drug.\n10. Previous systemic anticancer treatment (e.g., chemotherapy, targeted therapy, or biologics). Chinese herbal medicine with anticancer indications or immunomodulatory drugs (e.g., thymosin, interleukins) are allowed after a 2-week washout period.\n11. Active, known, or suspected autoimmune diseases, or a history of autoimmune disease within the last 2 years (subjects with vitiligo, psoriasis, alopecia, or Grave's disease who did not require systemic treatment in the past 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type 1 diabetes requiring only insulin replacement therapy may be included).\n12. Known history of primary immunodeficiency.\n13. Known history of organ transplantation (except corneal transplant) or hematopoietic stem cell transplant.\n14. History of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, or any pulmonary diseases with severe impairment of lung function.\n15. Known history of severe allergic reactions to other monoclonal antibodies or interferons, or to any ingredient in the study drug (e.g., sintilimab or interferon).\n16. Clinically uncontrolled third-space fluid accumulation, such as pleural effusion or ascites that cannot be controlled by drainage or other methods before enrollment.\n17. HIV infection (HIV antibody positive).\n18. Acute or chronic active hepatitis B (HBV DNA copy number ≥ 1 × 10³ copies\u002Fml or ≥ 200 IU\u002Fml) or acute or chronic active hepatitis C (HCV antibody positive); patients with HCV antibody positive but RNA negative are eligible for inclusion.\n19. Active pulmonary tuberculosis.\n20. Active or clinically uncontrolled severe infections.\n21. Symptomatic congestive heart failure (NYHA Class III-IV) or symptomatic or uncontrolled arrhythmia.\n22. Uncontrolled hypertension despite appropriate treatment (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).\n23. Any arterial thromboembolic event (e.g., myocardial infarction, unstable angina, pulmonary embolism, cerebral embolism) within 6 months before enrollment.\n24. History of deep vein thrombosis or any other severe thromboembolic event within 3 months before enrollment (implanted venous infusion ports or catheter-related thrombosis or superficial vein thrombosis are not considered \"severe\" thromboembolic events).\n25. Uncontrolled metabolic disorders or other non-malignant organ\u002Fsystemic diseases or cancer sequelae that would increase medical risks and\u002For create uncertainties in survival prognosis, and the investigator judges that the patient is unsuitable for enrollment.\n26. Hepatic encephalopathy, hepatorenal syndrome, or decompensated cirrhosis (Child-Pugh Class B or C).\n27. History of gastrointestinal perforation and\u002For fistulae, bowel obstruction (including incomplete bowel obstruction requiring parenteral nutrition), extensive bowel resection (e.g., partial colon or extensive small bowel resection resulting in chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea within 6 months prior to enrollment.\n28. Other acute or chronic diseases, psychiatric disorders, or abnormal laboratory test results that may:\n\n(1) Increase the risk related to participation in the study or study drug administration.\n\n(2) Interfere with the interpretation of study results and lead the investigator to determine that the patient is ineligible for participation.\n\n29\\. History of other primary malignancies, excluding:\n\n1. Malignancies that have been cured with no evidence of active disease for at least 5 years prior to enrollment, with a very low risk of recurrence.\n2. Non-melanoma skin cancer or malignant lentigo maligna with no evidence of disease recurrence after sufficient treatment.\n3. In situ carcinoma that has been treated sufficiently with no evidence of recurrence.\n\n30\\. Pregnant or breastfeeding female patients. 31. Other conditions that, according to the investigator's judgment, make the patient unsuitable for participation in the study.",{"count":204,"type":21},220,[24],"Melanoma has emerged as the fastest-growing malignancy in recent years, with incidence and mortality rates among both men and women in East Asian countries exceeding the Asian average. China ranks fifth among East Asian nations in melanoma incidence. Currently, immune checkpoint inhibitors are achieving significant breakthroughs in adjuvant melanoma therapy. This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy versus chemotherapy alone in patients with PD-L1-positive, completely resectable mucosal melanoma, thereby providing additional clinical evidence for treatment decisions.",[29,208],"PD-L1 Positive",[210,211,212,64],"Adjuvant Treatment","PD-L1-Positive","Resectable Mucosal Melanoma","2026-02-03",{"date":215,"type":34},"2026-02-10",{"date":217,"type":21},"2026-02-01",{"date":219,"type":21},"2029-09-30",{"name":221,"class":41},"The First Hospital of Jilin University",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":236,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":243,"locationsCount":42},"100619655","phase-2-iparomlimab-and-tuvoraleimab-injection-in-combination-with-bevacizumab-albumin-bound-paclitaxel-and-carboplatin-as-first--or-second-line-treatment-for-patients-with-advanced-acral-and-mucosal-melanoma-100619655","NCT07347444","Iparomlimab and Tuvoraleimab Injection in Combination With Bevacizumab, Albumin-bound Paclitaxel, and Carboplatin as First- or Second-line Treatment for Patients With Advanced Acral and Mucosal Melanoma","A Prospective, Single-arm, Multicenter, Phase II Clinical Study of Iparomlimab and Tuvoraleimab Injection in Combination With Bevacizumab, Albumin-bound Paclitaxel, and Carboplatin as First- or Second-line Treatment for Patients With Advanced Acral and Mucosal Melanoma","Inclusion Criteria:\n\n* Subjects (or their legal representatives\u002Fguardians) must sign the informed consent form, indicating that they understand the purpose of this study, are aware of the necessary procedures involved, and are willing to participate.\n* Aged ≥18 years and ≤75 years, regardless of gender.\n* Histologically or pathologically confirmed mucosal or acral melanoma.\n* Braf, Nras, and Ckit gene mutation status is unrestricted.\n* Unresectable or metastatic melanoma, having received ≤1 prior line of systemic therapy (disease recurrence or metastasis within 6 months after completion of adjuvant therapy is considered as first-line therapy).\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2.\n* Expected survival of more than 3 months.\n* At least one measurable lesion according to RECIST v1.1. Note: Brain metastases cannot serve as target lesions; Lesions previously treated with radiotherapy cannot serve as target lesions unless imaging demonstrates clear progression.\n* Laboratory test results within 7 days prior to screening (including day 7) must meet the following criteria: Neutrophil count ≥1.5×10⁹\u002FL; Platelet count ≥90×10⁹\u002FL; Hemoglobin ≥90 g\u002FL (without transfusion within 14 days); Serum total bilirubin ≤1.25 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN (≤5 × ULN for patients with liver metastases); Serum creatinine ≤1.25 × ULN.\n* Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (if the urine pregnancy test result is not conclusively negative, a serum pregnancy test is required, and the serum result shall prevail). If a female subject of childbearing potential engages in sexual activity with a non-sterilized male partner, she must use acceptable contraceptive methods starting from screening and must agree to continue their use for 120 days after the last dose of the study drug; whether to discontinue contraception after this time point should be discussed with the investigator.\n* If a non-sterilized male subject engages in sexual activity with a female partner of childbearing potential, he must use effective contraceptive methods from screening until 120 days after the last dose; whether to discontinue contraception after this time point should be discussed with the investigator.\n* Subjects are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\n* History or presence of other malignancies within the past 5 years, except for cured localized tumors (e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, etc.).\n* Participation in treatment with an investigational drug or use of an investigational device within 4 weeks prior to the first dose of study treatment.\n* Palliative local therapy for non-target lesions within 2 weeks prior to the first dose; Non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, etc., excluding IL-11 used for treating thrombocytopenia) within 2 weeks prior to the first dose; Treatment with Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week prior to the first dose.\n* Patients who have previously received iparomlimab and tuvoraleimab or other dual immunotherapy, bevacizumab, albumin-bound paclitaxel, or carboplatin.\n* Active autoimmune disease that has required systemic treatment in the past two years (i.e., with disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n* History of active or documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or chronic diarrhea.\n* History of immunodeficiency; Positive HIV antibody test; Current long-term use of systemic corticosteroids or other immunosuppressive agents.\n* Known active tuberculosis (TB); Subjects suspected of having active TB must undergo clinical evaluation to rule it out; Known active syphilis infection.\n* History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* History of non-infectious pneumonitis\u002Finterstitial lung disease that required systemic corticosteroid treatment or current presence of non-infectious pneumonitis.\n* Severe infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; Active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or C).\n* Subjects with active hepatitis B (HBsAg positive and HBV-DNA \\>1000 copies\u002FmL \\[200 IU\u002FmL\\] or above the lower limit of detection, whichever is higher). Note: Subjects with hepatitis B are required to receive anti-hepatitis B virus therapy during the study treatment.\n* Subjects with active hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection).\n* Major surgical procedure or significant traumatic injury within 30 days prior to the first dose, or planned major surgery within 30 days after the first dose (at the investigator's discretion); Minor local surgery (excluding peripherally inserted central catheter placement and port implantation) within 3 days prior to the first dose.\n* Presence of active central nervous system (CNS) metastases; Subjects with previously treated brain metastases are eligible if clinically stable for at least 2 weeks (calculated from the first dose of study drug) and off corticosteroids for at least 3 days prior to the first dose; Subjects with untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no requirement for corticosteroids, and no lesion with longest diameter \\>1.5 cm) are eligible and require periodic assessment during the study.\n* Known brainstem, leptomeningeal, spinal cord metastases, or spinal cord compression.\n* Subjects with clinically symptomatic or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.\n* Uncontrolled concurrent illness, including but not limited to symptomatic congestive heart failure (NYHA Class II or higher), unstable angina pectoris, acute myocardial ischemia, poorly controlled arrhythmias, decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the subject's ability to provide written informed consent.\n* History of myocarditis, cardiomyopathy, or malignant arrhythmia. Unstable angina, myocardial infarction, congestive heart failure (NYHA Class II or higher), or vascular disease (e.g., aortic aneurysm at risk of rupture) requiring hospitalization within 12 months prior to the first dose, or other cardiac impairment that may affect safety evaluation of the study drug (e.g., poorly controlled arrhythmia, myocardial ischemia); History of esophageal\u002Fgastric varices, severe ulcer, unhealed wound, gastrointestinal perforation, abdominal fistula, intra-abdominal abscess, or acute gastrointestinal hemorrhage within 6 months prior to the first dose; Acute exacerbation of chronic obstructive pulmonary disease within 1 month prior to the first dose; Any arterial thromboembolic event, Grade 3 or higher venous thromboembolism per NCI CTCAE v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to the first dose; Current hypertension with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive medication.\n* Current significant clinical or imaging evidence of gastrointestinal obstruction.\n* History of severe bleeding tendency or coagulation dysfunction; Imaging at screening shows tumor encasement of major blood vessels or significant necrosis\u002Fcavitation, and the investigator considers participation may pose a bleeding risk.\n* Subjects with tumor invasion of surrounding vital organs or blood vessels (e.g., heart\u002Fpericardium, trachea, esophagus, aorta, superior vena cava, etc.), at risk of developing tracheoesophageal fistula, esophagopleural fistula, or enteric fistula, etc.\n* Toxicities from prior anti-tumor therapy have not resolved to ≤ Grade 1 per NCI CTCAE v5.0 or to levels specified in the inclusion\u002Fexclusion criteria, except for alopecia and residual neuropathy from prior platinum therapy. Subjects with irreversible toxicity not expected to exacerbate with study treatment (e.g., hearing loss) may be included after consultation with the Medical Monitor. Subjects with long-term radiation-induced toxicity judged irreversible by the investigator may be included after consultation with the Medical Monitor.\n* Administration of a live vaccine within 30 days prior to the first dose, or planned administration during the study.\n* Known allergy to any component of any study drug; History of severe hypersensitivity reaction to other monoclonal antibodies.\n* Known history of psychiatric disorder, drug abuse, alcoholism, or substance abuse.\n* Pregnant or breastfeeding women.\n* Any condition, therapy, laboratory abnormality, or other circumstance that might confound study results, interfere with the subject's participation for the full duration, or participation is not in the best interest of the subject.\n* Local or systemic non-malignant disease, or tumor-associated conditions\u002Fsymptoms that pose significant medical risk and\u002For uncertainty regarding survival evaluation, such as leukemoid reaction (WBC \\>20×10⁹\u002FL), cachexia (e.g., known weight loss \\>10% in the 3 months prior to screening), etc.","75 Years",{"count":231,"type":21},48,[24],"This is a prospective, single-arm, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of iparomlimab and tuvoraleimab, in combination with bevacizumab, albumin-bound paclitaxel, and carboplatin as first- or second-line treatment in patients with acral and mucosal melanoma.",[235,29],"Acral Melanoma","NOT_YET_RECRUITING","2026-01-15",{"date":239,"type":34},"2026-01-16",{"date":241,"type":21},"2026-02",{"date":71,"type":21},{"name":244,"class":41},"Fudan University",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":252,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":255,"briefSummary":256,"conditions":257,"keywords":258,"overallStatus":236,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":4},"100611126","phase-2-combination-of-carilizumab-apatinib-and-radiotherapy-for-advanced-mucosal-melanoma-100611126","NCT07236528","Combination of Carilizumab, Apatinib, and Radiotherapy for Advanced Mucosal Melanoma","A Prospective, Multicenter, Single Arm, Open Label Clinical Study Evaluating the Efficacy and Safety of the Combination of Carilizumab With Apatinib Mesylate and Radiotherapy in the First-line Treatment of Advanced Mucosal Melanoma","Inclusion Criteria:\n\n1. Age ≥ 18 years old, ≤ 80 years old, gender not limited\n2. Confirmed by pathological histology, patients with recurrent, unresectable, or metastatic mucosal melanoma after surgery\n3. In the late stage, no systemic anti-tumor drug treatment has been received, and previous radical surgical resection, adjuvant or neoadjuvant therapy is allowed. However, it is required to be completed at least 4 weeks before randomization, and all treatment-related toxicity events have returned to normal or CTCAE 5.0 grade I or below (except for hair loss, skin hypopigmentation, well controlled hypothyroidism, and adrenal insufficiency)\n4. There must be at least one measurable lesion that has not undergone local treatment (according to RECIST v1.1 requirements, the length of the measurable lesion on spiral CT or MRI scan must be ≥ 10 mm or the length of enlarged lymph nodes must be ≥ 15 mm)\n5. At least one lesion that can receive radiotherapy\n6. ECOG PS 0 or 1 point\n7. Expected survival period ≥ 12 weeks\n8. No contraindications for treatment, with sufficient organ and bone marrow function: ① Absolute neutrophil count ≥ 1.5 × 109\u002FL ② Platelets ≥ 80 × 109\u002FL③ Hemoglobin ≥ 90 g\u002FL④ ALT and AST ≤ 1.5 × ULN⑤ Bilirubin ≤ 1.5 × ULN⑥ Blood creatinine ≤ 1.5 × ULN\n9. Patients may have a history of brain\u002Fmeningeal metastases, but they must have undergone local treatment (surgery\u002Fradiation therapy) before the start of the study and have been clinically stable for at least 3 months (corticosteroids are allowed to be used before randomization, but must be discontinued 2 weeks before starting the study drug)\n10. Non surgical sterilization or female patients of childbearing age are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period and within 12 months after the end of the study treatment period\n11. For male patients whose partners are women of childbearing age, effective contraception methods should be used during the trial period and within 12 months after the last dose. 11. Participants voluntarily join the study, sign informed consent forms, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Patients who have received VEGFR TKI treatment within the past 6 months (including neoadjuvant and adjuvant treatment periods)\n2. Individuals known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components\n3. History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation\n4. Previous thyroid dysfunction and inability to maintain normal thyroid function even with medication treatment\n5. Pregnant or lactating women\n6. Evidence of bleeding quality or significant coagulation dysfunction (not receiving anticoagulant therapy)\n7. Bleeding events occurring within 6 months prior to the first medication due to untreated or incompletely treated esophageal and\u002For gastric varices\n8. Major vascular disease (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) occurred within 6 months before the first use of medication\n9. Insufficient control of hypertension (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg) (based on the average of BP readings obtained from ≥ 2 measurements), allowing for the use of antihypertensive therapy to achieve the above parameters\n10. Previously experienced hypertensive crisis or hypertensive encephalopathy\n11. Within the past 3 months, there has been severe cardiovascular disease (such as New York Heart Association Grade II or above heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina pectoris\n12. Severe, unhealed, or cracked wounds, active ulcers, or untreated fractures\n13. Perform hollow needle biopsy or other minor surgery within 3 days before the first medication, excluding the placement of vascular access devices\n14. Major surgery should be performed within 4 weeks before the first medication, or expected to be required during the study period\n15. Those who have been treated with systemic immunosuppressive drugs (including but not limited to glucocorticoids \\[\\>10 mg\u002Fd prednisone or other corticosteroids with equivalent physiological doses\\], cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha \\[TNF - α\\] preparations) within 2 weeks prior to their first medication, or who are expected to require systemic immunosuppressive drugs during the study treatment period\n16. Subjects who have received or will receive a live vaccine within 30 days prior to the first dose, or who are expected to use the vaccine during the expected treatment period or within 5 months after the last dose\n\n176\\. Individuals known to be allergic to any investigational drug or excipient\n\n18\\. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders\n\n19\\. Researchers determine other situations that are not suitable for inclusion in the study.","80 Years",{"count":254,"type":21},30,[24],"This study is a prospective, multicenter, single arm, open label study aimed at evaluating the efficacy and safety of the combination of Carilizumab, Apatinib Mesylate, and first-line radiotherapy for advanced mucosal melanoma.",[29],[259,260,261,262,263],"radiotherapy","Carilizumab","Apatinib Mesylate","Mucosal melanoma","first-line treatment","2025-11-14",{"date":99,"type":34},{"date":267,"type":21},"2025-11-30",{"date":269,"type":21},"2028-05-31",{"name":271,"class":41},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":319,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":359},"100445919","phase-1-a-beta-only-il-2-immunotherapy-study-100445919","NCT05086692","A Beta-only IL-2 ImmunoTherapY Study","A Phase 1\u002F2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors","ABILITY-1","Key Inclusion Criteria:\n\n1. Aged at least 18 years (inclusive at the time of informed consent).\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)\n5. Demonstrated adequate organ function\n6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and\u002For MRI.\n7. Life expectancy of ≥ 12 weeks.\n8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.\n9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.\n\nKey Exclusion Criteria:\n\n1. Last administration of prior antitumor therapy:\n\n   * Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.\n   * Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\\\u003C2 weeks of radiotherapy) to non-CNS disease.\n   * Radiation therapy to the lung that is \\> 30Gy within 6 months prior to start of treatment.\n   * Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.\n2. Has known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.\n3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.\n4. Condition requiring long-term systemic treatment with either corticosteroids \\> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.\n5. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.\n6. Severe pulmonary, cardiac or other systemic disease.\n7. Known hepatitis B or C virus infection.\n8. Females who are pregnant or lactating or planning to become pregnant during the study.\n9. Has had an allogeneic tissue\u002Fsolid organ transplant.\n10. Active infection requiring systemic therapy.\n11. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol\n12. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.\n13. Known severe hypersensitivity to any component of study drug(s).\n14. Inability to comply with study and follow up procedures as judged by the Investigator.",{"count":281,"type":21},115,[52,24],"This is a Phase 1\u002F2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.",[285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308,235,29,27,309,310,311,312,313,314,315,316,317,318],"Advanced Solid Tumor","Unresectable Solid Tumor","Clear Cell Renal Cell Carcinoma","Triple Negative Breast Cancer","Non-Small Cell Lung Cancer Squamous","Non-Small Cell Lung Cancer Non-squamous","Colorectal Cancer (MSI-H)","Gastric Cancer","Cervical Cancer","Basal Cell Carcinoma","Bladder Cancer","Merkel Cell Carcinoma","Squamous Cell Carcinoma of Head and Neck","Cutaneous Squamous Cell Carcinoma","Pleural Mesothelioma","Esophageal Cancer","Endometrial Carcinoma","Solid Tumor","Solid Tumor, Adult","MSI-H Solid Malignant Tumor","Cancer With A High Tumor Mutational Burden","Epithelial Ovarian Carcinoma","Primary Peritoneal Cancer","Gastroesophageal Junction (GEJ) Cancer","DMMR Solid Malignant Tumor","Fallopian Tube Cancer","Ovarian Cancer","MSI-H Cancer","DMMR Cancer","Pancreas Adenocarcinoma (MSI-H)","Skin Cancer","Viral Cancer","Cervical Cancers","Endometrial Cancer",[320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,64,343,344,345,346,347,348,349],"IL-2","IL2","Interleukin-2","cancer","metastatic","ccRCC","TNBC","NSCLC","CRC","GEJ","intrahepatic","extrahepatic","MCC","SCCHN","CSCC","Gastroesophageal Junction","advanced","unresectable","MSI-H","dMMR","Microsatellite Instability-High","Mismatch Repair Deficient","PD-1","anti-PD-1","BCC","RCC","HCC","Tumor Mutation Burden High","TMB-H","PDAC","2025-07-03",{"date":352,"type":34},"2025-07-09",{"date":354,"type":34},"2021-08-27",{"date":356,"type":21},"2026-12-30",{"name":358,"class":74},"Medicenna Therapeutics, Inc.",27,{"id":361,"slug":4,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":366,"enrollmentInfo":367,"targetDuration":4,"studyType":22,"phases":369,"briefSummary":370,"conditions":371,"keywords":372,"overallStatus":236,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":42},"100548717","NCT06424626","A Trial of AK104 or AK112 in Combination With Axitinib in Patients With Metastatic Mucosal Melanoma","A Phase Ib, Open, Mono-center, Dose-reduction Tolerability Study of AK104 or AK112 in Combination With Axitinib in Patients With Metastatic Mucosal Melanoma","Inclusion Criteria:\n\n1、18 to 70 years old (at the time consent is obtained). 2、Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).\n\n3、Have histologically- or cytologically-confirmed diagnosis of Metastatic Mucosal Melanoma.\n\n4、Have a life expectancy of at least 3 months 5、Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6、Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team 7、Has adequate organ function as defined by:Absolute neutrophil count ≥ 1,500\u002FµL;Platelets ≥ 100,000\u002FµL;Hemoglobin ≥ 9 g\u002FdL;Crcl ≥ 50ml\u002Fmin creatinine clearance may be calculated using the institutional\u002Flaboratory standard method.Serum total bilirubin ≤ 1.5 x ULN ;Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN ;Albumin ≥28g\u002FL;International Normalized Ratio (INR) and aPTT \\\u003C1.5 x ULN. Left ventricular ejection fraction ≥50%.\n\n8、Have recovered from the effects of any prior radiotherapy or surgery 9、All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Prior treatment with anti-PD-1\u002FPD-L1\u002FPD-L2 antibody and Axitinib\n2. Is currently participating in a study of an investigational agent or using an investigational device\n3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment\n4. Has undergone major surgery within 30 days of Study Day 1\n5. Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer\n6. Has known active central nervous system (CNS) metastases\n7. Has carcinomatous meningitis\n8. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma\u002Fatopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study\n9. Has an active infection requiring systemic therapy\n10. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected)\n11. History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment","70 Years",{"count":368,"type":21},60,[52],"This study was a phase IB, single-center, open-label, two part(part A involved dose reduction, and part B involved cohort expansion) clinical trial evaluating the safety and clinical activity of AK104 or AK112 in combination with axitinib in patients with advanced mucosal melanoma.",[92,29,91],[92,373,374,29],"AK104","AK112","2024-05-16",{"date":377,"type":34},"2024-05-22",{"date":379,"type":21},"2024-05-21",{"date":381,"type":21},"2027-12-31",{"name":383,"class":41},"Peking University Cancer Hospital & Institute"]