drugset / Trial / NCT04546074
Imatinib Mesylate in Combination With Pembrolizumab in Patients With Melanoma
Phase 1/2
Unknown
22 enrolled
Keio University
Merck Sharp & Dohme LLC · collabOhara Pharmaceutical Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-09-14
- Primary completion
- 2024-10-31
- Completion
- 2025-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imatinib | Small molecule | 200 mg | — |
| Subject | Imatinib | Small molecule | 400 mg | — |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | — |