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)
Public ClinicalTrials.gov record NCT03374254. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03374254
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 116 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Binimetinib Drug
- Oxaliplatin Drug
- Leucovorin Drug
- 5-Fluorouracil [5-FU] Drug
- Irinotecan Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 16, 2018 (Actual)
- Primary completion
- Sep 8, 2021 (Actual)
- Completion
- Jul 18, 2023 (Actual)
- Last update posted
- Nov 21, 2024
2018 – 2023
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center ( Site 0102) | Duarte | California | 91010 | — |
| Anschutz Medical Campus, Anschutz Cancer Pavilion ( Site 0106) | Aurora | Colorado | 80045 | — |
| Yale Cancer Center ( Site 0108) | New Haven | Connecticut | 06520 | — |
| Moffitt Cancer Center ( Site 0111) | Tampa | Florida | 33612 | — |
| University of Chicago ( Site 0105) | Chicago | Illinois | 60637 | — |
| Rutgers Cancer Institute of New Jersey ( Site 0107) | New Brunswick | New Jersey | 08903-2681 | — |
| UPMC Cancer Center/Hillman Cancer Center ( Site 0113) | Pittsburgh | Pennsylvania | 15232 | — |
| Baylor Scott and White ( Site 0110) | Temple | Texas | 76508 | — |
| Seattle Cancer Care Alliance ( Site 0104) | Seattle | Washington | 98109 | — |
| Northwest Medical Specialties, PLLC ( Site 0101) | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03374254, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 21, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03374254 live on ClinicalTrials.gov.