Safety and Efficacy of Pembrolizumab (MK-3475) Plus Binimetinib Alone or Pembrolizumab Plus Chemotherapy With or Without Binimetinib in Metastatic Colorectal Cancer (mCRC) Participants (MK-3475-651/KEYNOTE-651)

PHASE1CompletedINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

February 16, 2018

Primary Completion Date

September 8, 2021

Study Completion Date

July 18, 2023

Conditions
Metastatic Colorectal Cancer
Interventions
BIOLOGICAL

Pembrolizumab

200 mg Pembrolizumab solution for IV infusion Q3W

DRUG

Binimetinib

tablet orally BID at 30 or 45 mg depending upon DLT profile

DRUG

Oxaliplatin

85 mg/m\^2 as IV infusion. Administered Q2W as part of mFOLFOX7 cocktail. Dose may be de-escalated to 70 mg/m\^2 if the standard dose of mFOLFOX7 is deemed too toxic per mTPI, based upon occurrence of DLTs.

DRUG

Leucovorin

400 mg/m\^2 as IV infusion. Administered Q2W as part of mFOLFOX7 or FOLFIRI cocktail, depending upon allocation.

DRUG

5-Fluorouracil [5-FU]

2400 mg/m\^2 over 46-48 hours as IV infusion. Administered Q2W as part of mFOLFOX7 or FOLFIRI cocktail, depending upon allocation. Dose may be de-escalated to 2000 mg/m\^2 if the standard dose of mFOLFOX7 or FOLFIRI is deemed too toxic per mTPI, based upon occurrence of DLTs.

DRUG

Irinotecan

180 mg/m\^2 as IV infusion. Administered Q2W as part of FOLFIRI cocktail. Dose may be de-escalated to 150 mg/m\^2 if the standard dose of FOLFIRI is deemed too toxic per mTPI, based upon occurrence of DLTs.

Trial Locations (14)

15232

UPMC Cancer Center/Hillman Cancer Center ( Site 0113), Pittsburgh

33612

Moffitt Cancer Center ( Site 0111), Tampa

60637

University of Chicago ( Site 0105), Chicago

76508

Baylor Scott and White ( Site 0110), Temple

80045

Anschutz Medical Campus, Anschutz Cancer Pavilion ( Site 0106), Aurora

91010

City of Hope National Medical Center ( Site 0102), Duarte

98109

Seattle Cancer Care Alliance ( Site 0104), Seattle

98405

Northwest Medical Specialties, PLLC ( Site 0101), Tacoma

06520

Yale Cancer Center ( Site 0108), New Haven

08903-2681

Rutgers Cancer Institute of New Jersey ( Site 0107), New Brunswick

T6G 1Z2

Cross Cancer Institute ( Site 0123), Edmonton

M5G 2M9

Princess Margaret Cancer Centre ( Site 0122), Toronto

H2X 3E4

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0124), Montreal

H3T 1E2

Jewish General Hospital ( Site 0121), Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Array BioPharma

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY