View clinical trials related to Advanced Mucosal Melanoma.
Filter by:This is a phase II, open, single-center study to explore the efficacy and safety of Envafolimab combined with recombinant human endostatin, temozolomide and cisplatin in the treatment of mucosal melanin. At the same time, the tissue and peripheral blood samples of the patients were taken for the determination of PD-L1 expression, ctDNA and other biomarkers and the results were analyzed to find the predictive factors of prognosis or curative effect. Patients with advanced mucosal melanoma who met the inclusion criteria but did not meet the exclusion criteria were enrolled in this study and received 6 cycles of Envafolimab combined with recombinant human endostatin, temozolomide and cisplatin. Patients without progression were then maintained with Envafolimab combined with recombinant human endostatin until disease progression, intolerable adverse reactions, patient death or withdrawal of informed consent. The longest administration time of recombinant human endostatin was no more than 1 year, and that of Envafolimab was not more than 2 years. The efficacy was evaluated for the first time at 6 weeks, every 6 weeks for the following year, and then every 12 weeks until the end of progress or treatment. The examination method was consistent with the baseline; it was expected to be included in the group for 18 months, and clinical observation until disease progression and patient death.
This is a randomized, controlled, multicenter Phase II clinical study to evaluate the efficacy and safety of toripalimab injection combined with axitinib in the first-line treatment of patients with advanced mucosal melanoma. The target population is the patients with previously untreated, histopathologically confirmed, unresectable or metastatic mucosal melanoma. At the randomization, patients are randomized 1:1:1 into three groups with approximately 33 subjects in each group to receive toripalimab injection plus axitinib, toripalimab injection monotherapy (subjects who meet the criteria after disease progression may cross over to receive toripalimab plus axitinib), or axitinib monotherapy (subjects who meet the criteria after disease progression may cross over to receive toripalimab plus axitinib); when the patient has disease progression or intolerable toxicity, the treatment is terminated, and the survival follow-up will be initiated.