NCT04546074

Imatinib Mesylate in Combination With Pembrolizumab in Patients With Melanoma

Imatinib Mesylate in Combination With Pembrolizumab in Patients With Advanced KIT-mutant Melanoma Following Progression on Standard Therapy: a Phase I/II Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Keio University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is an open-labelled single arm trial of pembrolizumab and imatinib mesylate in subjects with unresectable or metastatic KIT-mutant melanoma that are refractory to standard therapy. The phase Ib and II study will be conducted to evaluate the safety, tolerability and response rate data of this combination therapy. KIT-mutant tumors will be confirmed in previously biopsied tumors. This analysis will be done by next-generation sequencing.

Detailed description

This trial is conducted as "Advanced medicine" authorized by the Ministry of Health, Labor, and Welfare (MHLW) in Japan, and in in conformance with Clinical Trial Act. PIb study is a dose-escalation study comprising two dose levels of imatinib mesylate with fixed dose of pembrolizumab to evaluate safety and tolerability and identify maximum tolerated dose/administered, and determine recommended phase 2 dose (RP2D). In PII study, a Simon's minimax two-stage design is employed.The treatment period with the combination therapy of both studies will continue every 21 days for up to 33 cycles (approximately 2 years) as long as subjects are receiving benefit from treatment and have not had disease progression or met any criteria for study withdrawal.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab and Imatinib mesylate	In Phase Ib study: Level 1: Imatinib mesylate 200mg QD + Pembrolizumab 200mg Q3W, Level 2: Imatinib mesylate 400mg QD + Pembrolizumab 200mg Q3W
DRUG	Pembrolizumab and Imatinib mesylate	In Phase II study, eligible patients receive the dose determined in phase Ib cohort.

Timeline

• Start date: 2020-09-14
• Primary completion: 2024-10-31
• Completion: 2025-10-31
• First posted: 2020-09-11
• Last updated: 2023-10-03

Locations

1 site across 1 country: Japan