[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mucosal-melanoma-of-the-head-and-neck\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mucosal-melanoma-of-the-head-and-neck":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644407","classify-omm-multicenter-rare-disease-cohort-for-t-stage-reclassification-and-molecular-subtyping-based-precision-therapy-in-oral-mucosal-melanoma-100644407",false,"NCT07662694","CLASSIFY-OMM: Multicenter Rare Disease Cohort for T-Stage Reclassification and Molecular Subtyping-Based Precision Therapy in Oral Mucosal Melanoma","CLASSIFY-OMM","Inclusion Criteria:\n\n* Histopathologically confirmed primary oral mucosal melanoma (WHO criteria);\n\nPrimary site: oral mucosa (palate, gingiva, sublingual, buccal, hard palate, floor of mouth);\n\nReceiving or planning standard treatment (surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy);\n\nAge ≥18 years, any sex;\n\nComplete clinical data with pathology, imaging, and records (retrospective) OR willingness for long-term follow-up (prospective);\n\nSigned informed consent (prospective) or data meeting ethical waiver (retrospective).\n\nExclusion Criteria:\n\n* Primary melanoma originating from skin, eye, esophagus, or other non-oral mucosal sites;\n\nSecondary\u002Fmetastatic oral mucosal melanoma (primary not in oral cavity);\n\nUnavailable key clinical information (surgical records, pathology, imaging);\n\nPrior or concurrent other malignancy interfering with prognosis;\n\nSevere mental\u002Fcognitive disorders or poor compliance;\n\nSevere comorbidities (heart failure, liver\u002Frenal failure) affecting treatment or survival analysis;\n\nPatient refusal or withdrawal of informed consent.","ALL","18 Years",{"count":19,"type":20},1100,"ESTIMATED","OBSERVATIONAL","This bidirectional cohort study (retrospective + prospective) focuses on three key challenges in oral mucosal melanoma (OMM): clinical staging based on depth of invasion (DOI), molecular subtyping, and precision therapy. By integrating DOI-driven T-stage reclassification, genomic profiling, and longitudinal follow-up, we aim to build a population-specific, high-quality evidence resource to support refined staging, CDK4-targeted treatment, and prognostic modeling for Chinese OMM patients.",[24,25],"Mucosal Melanoma of the Head and Neck","Oral Melanoma",[27],"Mucosal Melanoma","NOT_YET_RECRUITING","2026-06-17",{"date":31,"type":32},"2026-06-23","ACTUAL",{"date":34,"type":20},"2026-07-01",{"date":36,"type":20},"2029-12-30",{"name":38,"class":39},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":40},"100638184","phase-2-exploratory-clinical-study-of-neoadjuvant-immunotherapy-combined-with-chemotherapy-in-malignant-melanoma-of-nasal-and-paranasal-mucosa-100638184","NCT07614828","Exploratory Clinical Study of Neoadjuvant Immunotherapy Combined With Chemotherapy in Malignant Melanoma of Nasal and Paranasal Mucosa","Inclusion Criteria:\n\n* Histopathologically confirmed diagnosis of malignant melanoma of the nasal cavity and paranasal sinuses.\n* T stage of T3 or T4a.\n* Age ≥18 years.\n* No distant metastasis.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, with general condition tolerating chemotherapy and general anesthesia for surgery.\n* Locally resectable with curative intent, and able to undergo contrast-enhanced CT or contrast-enhanced MRI examinations.\n* Adequate organ function: Hematology: white blood cells ≥3.0 × 10\\^9\u002FL; absolute neutrophil count ≥1.5 × 10\\^9\u002FL; hemoglobin ≥80 g\u002FL; platelets ≥100 × 10\\^9\u002FL. Hepatic function: total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤3 × ULN. Coagulation: international normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Renal function: serum creatinine ≤1.5 × ULN.\n* Patients with recurrence after prior curative surgery are allowed; for recurrent patients, chemotherapy and immune therapy must have been discontinued for more than 6 months.\n\nExclusion Criteria:\n\n* Patients who refuse to sign the informed consent form.\n* Patients with uncontrolled comorbidities that, in the investigator's judgment, would interfere with treatment.\n* Patients currently suffering from another malignant tumor or with synchronous multiple primary tumors that require treatment.\n* Patients with surgical contraindications, such as severe cardiopulmonary disease or coagulation disorders.\n* Patients with autoimmune diseases.\n* Patients currently using immunosuppressants, or receiving systemic glucocorticoids for immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent), and who continue to use them within 2 weeks prior to first dosing.\n* Prior treatment with PD-1 monoclonal antibodies or PD-L1 monoclonal antibodies; or a history of severe allergic reactions to other monoclonal antibodies.\n* Receipt of a live vaccine within 6 weeks prior to first dosing, or the possibility of receiving a live vaccine during the study.\n* Any condition that may compromise protocol adherence or safety during the study.\n* Uncontrolled active infection.\n* Pregnant or breastfeeding women.\n* Any other condition deemed unsuitable for enrollment.",{"count":48,"type":20},25,"INTERVENTIONAL",[51],"PHASE2","Sinonasal mucosal malignant melanoma (SNMM) is a nasal and paranasal sinus malignancy with a low incidence and extremely poor prognosis, exhibiting specificity in Asian populations. For resectable SNMM, the efficacy of neoadjuvant immunotherapy is unclear. This prospective clinical study aims to explore the survival prognosis of neoadjuvant immunotherapy combing radiochemotherapy after Endoscopic Surgery for resectable SNMM.",[24],"RECRUITING","2026-05-22",{"date":57,"type":32},"2026-05-29",{"date":59,"type":32},"2023-06-01",{"date":61,"type":20},"2026-06-30",{"name":63,"class":39},"Eye & ENT Hospital of Fudan University",{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":49,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":40},"100386975","phase-2-pembrolizumab-and-hypofractionated-radiation-therapy-for-the-treatment-of-mucosal-melanoma-100386975","NCT04318717","Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma","Adjuvant Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed mucosal melanoma that has undergone surgical resection. Patient must not have received prior radiation therapy within the area of interest.\n* At least 16 years of age.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 70%)\n* Normal bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1,200\u002FmcL\n  * Platelets ≥ 100,000\u002FmcL\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Creatinine clearance \\> 30 mL\u002Fmin by Cockcroft-Gault\n* The effects of pembrolizumab on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and 6 months after last dose of pembrolizumab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 6 months after last dose of pembrolizumab.\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.\n* Received radiation therapy within the area of interest.\n* Currently receiving any other investigational agents.\n* Metastatic disease.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or other agents used in the study.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. The use of up to 10 mg\u002Fday of prednisone or equivalent is approved and does not exclude the patient from the trial.\n* Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, \\> 10 mg of prednisone per day, 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. The use of up to 10 mg\u002Fday of prednisone or equivalent is approved and does not exclude the patient from the trial.\n* Has a history of (non-infectious) pneumonitis\u002FInterstitial lung disease that required maintenance steroids (\\>10 mg of prednisone) or current pneumonitis\u002Finterstitial lung disease.\n* Has received a live vaccine or live-attenuated vaccination within 30 days of planned treatment start. Administration of killed vaccines is allowed.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.\n* Patients with HIV are eligible unless their CD4+ T-cell counts are \\\u003C 350 cells\u002FmcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.","16 Years",{"count":73,"type":20},20,[51],"This is an open-label, single center, one cohort, non-randomized, phase II study. The aim is to evaluate the efficacy and safety of the combination of hypofractionated radiotherapy (HRT) and pembrolizumab on local tumor control in mucosal melanoma patients. Treatment effect will be compared with historical radiation therapy-alone control data.",[24],{"date":78,"type":32},"2026-05-27",{"date":80,"type":32},"2020-05-29",{"date":82,"type":20},"2032-07-31",{"name":84,"class":39},"Washington University School of Medicine"]