Who is sponsoring NCT04546074?

NCT04546074 is sponsored by Keio University.

What drugs are being tested in NCT04546074?

Interventions in NCT04546074: Pembrolizumab and Imatinib mesylate, Pembrolizumab and Imatinib mesylate.

Is NCT04546074 still recruiting?

NCT04546074 is currently status unknown. Last updated 3 October 2023.

Last reviewed 2023-10-03 · How we verify

NCT04546074

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Imatinib Mesylate in Combination With Pembrolizumab in Patients With Melanoma

Status unknown Phase 1, PHASE2 Last updated 3 October 2023

What this trial tests

Phase 1, PHASE2 trial testing Pembrolizumab and Imatinib mesylate in Melanoma in 22 participants. Status unknown.

Timeline

14 September 2020

Primary endpoint
31 October 2024

31 October 2025

Quick facts

Lead sponsor	Keio University
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	14 September 2020
Primary completion	31 October 2024
Estimated completion	31 October 2025
Sites	1 location across Japan

Drugs / interventions tested

Pembrolizumab and Imatinib mesylate — full drug profile →
Pembrolizumab and Imatinib mesylate — full drug profile →

Conditions studied

Melanoma — all drugs for Melanoma →

Sponsor

Keio University

Who can join

20 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Hypoxia-dependent drivers of melanoma progression.
D'Aguanno S, Mallone F, Marenco M, Del Bufalo D, et al · · 2021 · cited 67× · PMID 33964953 · DOI 10.1186/s13046-021-01926-6
Cancer-associated fibroblasts as therapeutic targets for cancer: advances, challenges, and future prospects.
Cao Z, Quazi S, Arora S, Osellame LD, et al · · 2025 · cited 57× · PMID 39780187 · DOI 10.1186/s12929-024-01099-2
Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
Imatinib mesylate in combination with pembrolizumab in patients with advanced KIT-mutant melanoma following progression on standard therapy: A phase I/II trial and study protocol.
Hirai I, Tanese K, Fukuda K, Fusumae T, et al · · 2021 · cited 8× · PMID 34889232 · DOI 10.1097/md.0000000000027832
Recent Advances in Immunotherapy for Melanoma: Perspectives on the Development of Novel Treatments: A Mini Review.
Muto Y, Fujimura T, Asano Y. · · 2025 · cited 5× · PMID 40647561 · DOI 10.3390/cancers17132265
PROTAC-based protein degradation: a window of opportunity for melanoma therapy.
Gentile G, D'Aguanno S, Di Martile M, Petricca A, et al · · 2026 · PMID 41761284 · DOI 10.1186/s12929-026-01225-2
Unraveling vascular mechanisms in melanoma: roles of angiogenesis and vasculogenic mimicry in tumor progression and therapeutic resistance.
Serratì S, Raho L, De Giosa G, Porcelli L, et al · · 2025 · PMID 41251262 · DOI 10.20892/j.issn.2095-3941.2025.0048

Verify or expand the search:

Other recruiting trials for Melanoma

Currently open trials in the same condition.

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NCT07225036 — Promoting Immunotherapy Efficacy With Low-Dose Liver RT · NA · recruiting
NCT07379138 — Studying Quality of Life Inclusive of Mental Health and Cognitive Behavioral Therapy for Cancer Distress for the Improve · NA · recruiting

Other Keio University trials

Trials by the same sponsor.

NCT06913907 — Changes in MTX-PG Concentrations During Subcutaneous MTX Therapy in Patients With Rheumatoid Arthritis(COSMOS Study) · Phase 4 · recruiting
NCT06814873 — Enhanced Human Sensorimotor Integration Via Self-modulation of the Somatosensory Activity · NA · completed
NCT04699994 — Prospective Trial to Evaluate the Safety and Efficacy to Treat Esophageal Cancer Using 5-FU, Oxaliplatin, and Docetaxel · Phase 2 · unknown
NCT03505008 — Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04546074 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Keio University
Last refreshed: 3 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04546074.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing