Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: 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)
Study ID: NCT03374254
Conditions
Study Description
Brief Summary: The purpose of this study is to determine safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) for the following combinations: pembrolizumab plus binimetinib (Cohort A), pembrolizumab plus mFOLFOX7 (oxaliplatin 85 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2) (Cohort B), pembrolizumab plus mFOLFOX7 and binimetinib (Cohort C), pembrolizumab plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\]400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) (Cohort D), and pembrolizumab plus FOLFIRI and binimetinib (Cohort E).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center ( Site 0102), Duarte, California, United States
Anschutz Medical Campus, Anschutz Cancer Pavilion ( Site 0106), Aurora, Colorado, United States
Yale Cancer Center ( Site 0108), New Haven, Connecticut, United States
Moffitt Cancer Center ( Site 0111), Tampa, Florida, United States
University of Chicago ( Site 0105), Chicago, Illinois, United States
Rutgers Cancer Institute of New Jersey ( Site 0107), New Brunswick, New Jersey, United States
UPMC Cancer Center/Hillman Cancer Center ( Site 0113), Pittsburgh, Pennsylvania, United States
Baylor Scott and White ( Site 0110), Temple, Texas, United States
Seattle Cancer Care Alliance ( Site 0104), Seattle, Washington, United States
Northwest Medical Specialties, PLLC ( Site 0101), Tacoma, Washington, United States
Cross Cancer Institute ( Site 0123), Edmonton, Alberta, Canada
Princess Margaret Cancer Centre ( Site 0122), Toronto, Ontario, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0124), Montreal, Quebec, Canada
Jewish General Hospital ( Site 0121), Montreal, Quebec, Canada
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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