drugset / Trial / NCT02132754

Study of MK-4166 and MK-4166 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4166-001)

NCT02132754

Phase 1 Completed 116 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is planned to be a 5-part dose-escalation study to determine the safety and tolerability of MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy, and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) of MK-4166 and MK-4166 plus pembrolizumab by defining dose-limiting toxicities (DLTs) in participants with advanced solid tumors.

Timeline

Start
2014-06-27
Primary completion
2019-07-31
Completion
2019-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-4166 Monoclonal antibody 0.0015 mg Intravenous
Subject MK-4166 Monoclonal antibody 0.0045 mg Intravenous
Subject MK-4166 Monoclonal antibody 0.014 mg Intravenous
Subject MK-4166 Monoclonal antibody 0.04 mg Intravenous
Subject MK-4166 Monoclonal antibody 0.12 mg Intravenous
Subject MK-4166 Monoclonal antibody 0.37 mg Intravenous
Subject MK-4166 Monoclonal antibody 1.1 mg Intravenous
Subject MK-4166 Monoclonal antibody 3.3 mg Intravenous
Subject MK-4166 Monoclonal antibody 10 mg Intravenous
Subject MK-4166 Monoclonal antibody 30 mg Intravenous
Subject MK-4166 Monoclonal antibody 42 mg Intravenous
Subject MK-4166 Monoclonal antibody 59 mg Intravenous
Subject MK-4166 Monoclonal antibody 82 mg Intravenous
Subject MK-4166 Monoclonal antibody 120 mg Intravenous
Subject MK-4166 Monoclonal antibody 170 mg Intravenous
Subject MK-4166 Monoclonal antibody 240 mg Intravenous
Subject MK-4166 Monoclonal antibody 340 mg Intravenous
Subject MK-4166 Monoclonal antibody 480 mg Intravenous
Subject MK-4166 Monoclonal antibody 670 mg Intravenous
Subject MK-4166 Monoclonal antibody 900 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications