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NCT03374254 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Metastatic Colorectal Cancer, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
- 14
- Study locations
NCT03374254: Completed Phase 1 study of Metastatic Colorectal Cancer, sponsored by Merck Sharp & Dohme.
NCT03374254 is a Phase 1 study of Metastatic Colorectal Cancer that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 116 participants, below the 183-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (37% lower). The trial reports 14 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03374254, a Phase 1 study of Metastatic Colorectal Cancer, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
- 14
- Study locations
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).
Primary Outcome
The occurrence of any of the following toxicities during Part 1 of the study (the first 21 days for Cohort A, first 28 days for Cohorts B,C, D, \& E), if possibly, probably or definitely related to study treatment, was considered a DLT: Grade (Gr) 4 non hematologic toxicity, Gr 4 hematologic toxicity lasting \>7 days, Gr 3 thrombocytopenia, Any non-hematologic AE ≥Gr 3 in severity, Any Gr 3 or Gr 4 non-hematologic laboratory value, Febrile neutropenia Gr 3 or Gr 4, Any prolonged delay in initia
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 |
What the finished NCT03374254 record still lists
NCT03374254 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 183-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (37% lower).
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.
NCT03374254 lists 14 locations in 12 states (Washington, Quebec, California).
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.
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).
Who is sponsoring clinical trial NCT03374254?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03374254's enrollment target sits among peer trials
116 20th of 45 higher than 26 of 45 other Metastatic Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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