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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)
NCT03374254 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Binimetinib
- DRUG 5-Fluorouracil [5-FU]
Study Locations (14)
Washington
- Seattle Cancer Care Alliance ( Site 0104) — Seattle
- Northwest Medical Specialties, PLLC ( Site 0101) — Tacoma
Quebec
- Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0124) — Montreal
- Jewish General Hospital ( Site 0121) — Montreal
California
- City of Hope National Medical Center ( Site 0102) — Duarte
Colorado
- Anschutz Medical Campus, Anschutz Cancer Pavilion ( Site 0106) — Aurora
Connecticut
- Yale Cancer Center ( Site 0108) — New Haven
Florida
- Moffitt Cancer Center ( Site 0111) — Tampa
Illinois
- University of Chicago ( Site 0105) — Chicago
New Jersey
- Rutgers Cancer Institute of New Jersey ( Site 0107) — New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2018-02-16 |
| Est. Completion | 2023-07-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03374254
The ClinicalTrials.gov registry entry for NCT03374254 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03374254 reports 14 study locations spanning 12 distinct geographic areas — top geographies include Washington, Quebec, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03374254 about?
NCT03374254 is a clinical study titled "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)". 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...
What is the current status of trial NCT03374254?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2018-02-16. Estimated completion is 2023-07-18.
What conditions does trial NCT03374254 study?
This clinical trial studies the following conditions: Metastatic Colorectal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03374254?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Leucovorin (DRUG), Oxaliplatin (DRUG), Binimetinib (DRUG), 5-Fluorouracil [5-FU] (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03374254?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03374254 being conducted?
This trial has 14 study locations across California, Colorado, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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