Phase II Study in the Treatment of Patients With Advanced Mucinous Melanoma
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
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.