Study of Binimetinib + Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation
Public ClinicalTrials.gov record NCT03271047. 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
An Open-label Phase 1b/2 Study of Binimetinib Administered in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, open-label, Phase 1B/2 study to evaluate the safety and assess the preliminary anti-tumor activity of binimetinib administered in combination with nivolumab or nivolumab + ipilimumab in adult patients with advanced metastatic colorectal cancer (mCRC) with microsatellite stable (MSS) disease and presence of a RAS mutation that have received at least one prior line of therapy and no more than 2 prior lines of therapy. The study contains a Phase 1b period to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) and schedule of binimetinib followed by a randomized Phase 2 period to assess the efficacy of the combinations.
Study identification
- NCT ID
- NCT03271047
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 75 participants
Conditions and interventions
Conditions
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
- Oct 18, 2017 (Actual)
- Primary completion
- Oct 13, 2020 (Actual)
- Completion
- Feb 25, 2021 (Actual)
- Last update posted
- Jan 4, 2022
2017 – 2021
United States locations
- U.S. sites
- 33
- U.S. states
- 9
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Hematology/Oncology | Los Angeles | California | 90095 | — |
| UCLA Hematology/Oncology - Santa Monica | Santa Monica | California | 90404 | — |
| Christiana Care Health Services, Helen F. Graham Cancer Center Pharmacy, Suite 3200 | Newark | Delaware | 19713 | — |
| Christiana Care Health Services, Helen F. Graham Cancer Center | Newark | Delaware | 19713 | — |
| Christiana Care Oncology Hematology, Helen F Graham Cancer Center, Suite 2400 | Newark | Delaware | 19713 | — |
| Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer Center | Newark | Delaware | 19713 | — |
| Christiana Care Health Services, Christiana Hospital | Newark | Delaware | 19718 | — |
| Georgetown University Medical Center Department of Pharmacy, Research | Washington D.C. | District of Columbia | 20007 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | — |
| Indiana CTSI Clinical Research Center (ICRC) | Indianapolis | Indiana | 46202 | — |
| Indiana University Health Hospital | Indianapolis | Indiana | 46202 | — |
| Indiana University Health Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Investigational Drug Services IUHSCC | Indianapolis | Indiana | 46202 | — |
| Sidney &Lois Eskenazi Hospital | Indianapolis | Indiana | 46202 | — |
| Spring Mill Medical Center | Indianapolis | Indiana | 46290 | — |
| Siteman Cancer Center - Barnes St. Peters | City of Saint Peters | Missouri | 63376 | — |
| Siteman Cancer Center - West County | Creve Coeur | Missouri | 63141 | — |
| Siteman Cancer Center - North County | Florissant | Missouri | 63031 | — |
| Center for Outpatient Health (Dermatology Clinic) | St Louis | Missouri | 63108 | — |
| Center for Outpatient Health (Ophthalmology Clinic) | St Louis | Missouri | 63108 | — |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center - South County | St Louis | Missouri | 63129 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Investigational Drug Service of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Sarah Cannon Research Institute | Chattanooga | Tennessee | 37404 | — |
| SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee | 37404 | — |
| Tennessee Oncology, PLLC | Cleveland | Tennessee | 37311 | — |
| Tennessee Oncology NASH - SCRI - PPDS | Nashville | Tennessee | 37203 | — |
| The Sarah Cannon Research Institute. | Nashville | Tennessee | 37203 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
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 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03271047, 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 Jan 4, 2022 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03271047 live on ClinicalTrials.gov.