Phase II Study in the Treatment of Patients With Advanced Mucinous Melanoma
- Conditions
- Advanced Mucosal Melanoma
- Interventions
- Registration Number
- NCT03941795
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 99
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description JS001(Toripalimab Injection) Combined With Axitinib JS001 and Axitinib - Axitinib alone Axitinib 1 MG [Inlyta] - JS001 alone JS001(Toripalimab Injection) -
- Primary Outcome Measures
Name Time Method the progression-free survival (PFS) 36 months Progression-free survival (PFS) per RECIST 1.1 criteria: Time from the date of randomization to the first documented disease progression (per RECIST 1.1 criteria), or death from any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method INV-ORR 36 months INV-ORR in crossover subjects is the number of subjects with DOR of CR or PR based on INV assessment divided by the number of crossover subjects. DOR is defined as the best response recorded as measured by INV from the date of the first crossover dose to the date of objective documentation of progression per RECIST 1.1 or the date of subsequent therapy, including tumor-directed radiotherapy and tumor-directed surgery, whichever occurs first. For subjects without documented progression or subsequent treatment, all available response designations will be assigned to the DOR evaluation. Baseline tumor assessments for crossover subjects are based on the last tumor assessment for monotherapy prior to the combination crossover. Exploratory endpoints will be analyzed at the time of primary endpoint analysis if data are available.
ORR 36 months Objective response rate (ORR) according to RECIST 1.1;
PFS 36 months Progression-free survival (PFS) according to RECIST 1.1;
DOR 36 months Duration of response (DOR) according to RECIST 1.1;
TTR 36 months Time to response (TTR) according to RECIST 1.1;
DCR 36 months Disease control rate (DCR) according to RECIST 1.1;
OS 36 months Overall survival (OS): Time from the date of randomization to death from any cause. Surviving patients as of the date of analysis will be censored at the date of their last contact.
safety: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment 36 months Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Trial Locations
- Locations (2)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Baishen First Hospital of Jilin University
🇨🇳Shengyang, Liaoning, China