Imatinib Mesylate in Combination With Pembrolizumab in Patients With Melanoma

  • STATUS
    Recruiting
  • End date
    Oct 31, 2025
  • participants needed
    22
  • sponsor
    Keio University
Updated on 19 April 2022
metastatic melanoma
measurable disease
KIT
neutrophil count
pembrolizumab
brain metastases
immunomodulators
immunologic adjuvant

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.

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.

Details
Condition Melanoma
Treatment Pembrolizumab and Imatinib mesylate
Clinical Study IdentifierNCT04546074
SponsorKeio University
Last Modified on19 April 2022

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