MedTrace Logo

Imatinib Mesylate in Combination With Pembrolizumab in Patients With Melanoma

NCT04546074 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-10-03

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Ohara Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Keio University

    lead OTHER

Principal Investigators

  • Takeru Funakoshi, MD · Keio University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2024-10-31
Completion
2025-10-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04546074 on ClinicalTrials.gov