NCT05274438

Imatinib and Toripalimab in Patients With Locally Advanced/Metastatic Melanoma Harbored With CKIT Mut

A Single-arm, Phase II Clinical Study of Imatinib Mesylate Combined With Toripalimab in the Treatment of Stage III Unresectable and Stage IV Melanoma Harbored With CKIT Mut

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is a single-center, single-arm Phase II clinical study. This clinical trial aimed to evaluate the PFS of imatinib combined with toripalimab in stage III unresectable and stage IV melanoma with CKIT gene mutation.

Detailed description

This study consisted of two phases: the first phase was the dose exploration phase, and the second phase was the extension group. In phase I, 3 patients were enrolled, starting with imatinib monotherapy, 400mg qd, for 2 cycles (6 weeks), followed by imatinib 400mg qd combined with toripalimab 240mg q3w. If DLT was not observed, the original dose was extended to 37 patients in phase ii; If there was 1 DLT in the first stage, the number of patients in the first stage was extended to 6. If there was no DLT, the patients entered the extended stage. If ≥2 DLT cases occurred in the first phase, imatinib was reduced to 300mg QD and toripalimab 240mg q3W, and the "3+3" study was restarted. If DLT≤1 case, enter extended group (imatinib 300mg qd and toripalimab 240mg q3W); The longest cumulative use period of the two drugs was 2 years. When patients develop disease progression or develop intolerable toxicity, treatment is ended and follow-up for survival is entered.

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	JS001+Imatinib mesylate	This study consisted of two phases: the first phase was the dose exploration phase, and the second phase was the extension group. In phase I, 3 patients were enrolled, starting with imatinib monotherapy, 400mg qd, for 2 cycles (6 weeks), followed by imatinib 400mg qd combined with toripalimab 240mg q3w. If DLT was not observed, the original dose was extended to 37 patients in phase ii; If there was 1 DLT in the first stage, the number of patients in the first stage was extended to 6. If there was no DLT, the patients entered the extended stage. If ≥2 DLT cases occurred in the first phase, imatinib was reduced to 300mg QD and toripalimab 240mg q3W, and the "3+3" study was restarted. If DLT≤1 case, enter extended group (imatinib 300mg qd and toripalimab 240mg q3W); The longest cumulative use period of the two drugs was 2 years. When patients develop disease progression or develop intolerable toxicity, treatment is ended and follow-up for survival is entered.

Timeline

• Start date: 2021-01-26
• Primary completion: 2023-03-01
• Completion: 2023-04-30
• First posted: 2022-03-10
• Last updated: 2022-03-10

Locations

1 site across 1 country: China