Clinical Trials Search
Clinical Trial 19384
Interventions:Binimetinib; FOLFIRI; FOLFOX; Pembrolizumab (Keytruda)
Study Type: Treatment
Phase of Study: Phase I
- Richard Kim
A Phase 1b Multi-cohort Study of the Combination of Pembrolizumab (MK-3475) plus Binimetinib alone or the Combination of Pembrolizumab plus Chemotherapy with or without Binimetinib in Participants with Metastatic Colorectal Cancer (KEYNOTE-651)
The purpose of this study is to test the safety of the study drugs, pembrolizumab with Binimetinib alone or in combination with standard of care chemotherapies to see how well the drugs work together and to see how the body handles the drug combinations to help determine the right dose.
Primary Objectives: To determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) for the following cohorts: Cohort A (pembrolizumab in combination with binimetinib in mCRC participants previously treated with fluoropyrimidine,irinotecan, and oxaliplatin). Cohort B (pembrolizumab in combination with mFOLFOX7 in previously untreated mCRC participants). Cohort C (pembrolizumab in combination with mFOLFOX7 and binimetinib in previously untreated mCRC participants). Cohort D (pembrolizumab in combination with FOLFIRI in mCRC participants previously treated with one line of a fluoropyrimidine plus oxaliplatin based therapy. Cohort E (pembrolizumab in combination with FOLFIRI and binimetinib in mCRC participants previously treated with one line of fluoropyrimidine plus oxaliplatin based regimen).