Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (MK-5618-001)

Phase 1 Terminated 32 enrolled Merck Sharp & Dohme LLC

Non-randomizedSequentialOpen-labelTreatment

Summary

This study will examine the safety, pharmacokinetics, and efficacy of escalating doses of selumetinib (MK-5618) in combination with intravenous (IV) pembrolizumab (MK-3475) for participants with advanced / metastatic solid tumors.

Timeline

Start: 2019-03-18
Primary completion: 2022-06-28
Completion: 2022-06-28

Publications

Results Chenard-Poirier M, Hansen AR, Gutierrez ME, Rasco D, Xing Y, Chen LC, Zhou H, Webber AL, Freshwater T, Sharma MR. A phase 1 trial of the MEK inhibitor selumetinib in combination with pembrolizumab for advanced or metastatic solid tumors. Invest New Drugs. 2024 Jun;42(3):241-251. doi: 10.1007/s10637-024-01428-0. Epub 2024 Mar 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Selumetinib	Small molecule	50 mg	Oral
Subject	Selumetinib	Small molecule	75 mg	Oral
Subject	Selumetinib	Small molecule	100 mg	Oral
Subject	Selumetinib	Small molecule	125 mg	Oral

Indications

No indication recorded.