Study of MK-1248 With and Without Pembrolizumab (MK-3475) for Participants With Advanced Solid Tumors (MK-1248-001)

Phase 1 Terminated 37 enrolled Merck Sharp & Dohme LLC

Non-randomizedParallel-groupOpen-labelTreatment

Summary

In this study, participants with advanced solid tumors were assigned to receive escalating doses of either MK-1248 alone or MK-1248 in combination with pembrolizumab (MK-3475). This study used the number of dose-limiting toxicities (DLTs) at each dose level to find and confirm the maximum tolerated dose (or maximum administered dose) for MK-1248 alone and in combination with pembrolizumab.

Timeline

Start: 2015-11-12
Primary completion: 2018-10-17
Completion: 2018-10-17

Outcome

Outcome not reported

Stopped (Enrollment): “Enrollment prematurely discontinued due to program prioritization \& not due to any safety concerns.”

Publications

Geva R, Voskoboynik M, Dobrenkov K, Mayawala K, Gwo J, Wnek R, Chartash E, Long GV. First-in-human phase 1 study of MK-1248, an anti-glucocorticoid-induced tumor necrosis factor receptor agonist monoclonal antibody, as monotherapy or with pembrolizumab in patients with advanced solid tumors. Cancer. 2020 Nov 15;126(22):4926-4935. doi: 10.1002/cncr.33133. Epub 2020 Aug 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MK-1248	Monoclonal antibody	0.12 mg	Intravenous
Subject	MK-1248	Monoclonal antibody	60 mg	Intravenous
Subject	MK-1248	Monoclonal antibody	170 mg	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

Indications

No indication recorded.