116
Participants
Start Date
February 16, 2018
Primary Completion Date
September 8, 2021
Study Completion Date
July 18, 2023
Pembrolizumab
200 mg Pembrolizumab solution for IV infusion Q3W
Binimetinib
tablet orally BID at 30 or 45 mg depending upon DLT profile
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.
Leucovorin
400 mg/m\^2 as IV infusion. Administered Q2W as part of mFOLFOX7 or FOLFIRI cocktail, depending upon allocation.
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.
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.
UPMC Cancer Center/Hillman Cancer Center ( Site 0113), Pittsburgh
Moffitt Cancer Center ( Site 0111), Tampa
University of Chicago ( Site 0105), Chicago
Baylor Scott and White ( Site 0110), Temple
Anschutz Medical Campus, Anschutz Cancer Pavilion ( Site 0106), Aurora
City of Hope National Medical Center ( Site 0102), Duarte
Seattle Cancer Care Alliance ( Site 0104), Seattle
Northwest Medical Specialties, PLLC ( Site 0101), Tacoma
Yale Cancer Center ( Site 0108), New Haven
Rutgers Cancer Institute of New Jersey ( Site 0107), New Brunswick
Cross Cancer Institute ( Site 0123), Edmonton
Princess Margaret Cancer Centre ( Site 0122), Toronto
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0124), Montreal
Jewish General Hospital ( Site 0121), Montreal
Collaborators (1)
Array BioPharma
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY