Study of Binimetinib + Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation
Completed · Phase 2
Conditions studied: MSS, RAS-mutant Colorectal Cancer
In brief
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.
Key facts
- Study ID
- NCT03271047
- Run by
- Pfizer
- People needed
- 75
- Starts
- 2017-10-18
- Expected to finish
- 2021-02-25
- Last updated by the study team
- 2022-01-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCLA Hematology/Oncology — Los Angeles, California, United States
- UCLA Hematology/Oncology - Santa Monica — Santa Monica, California, United States
- Christiana Care Health Services, Helen F. Graham Cancer Center Pharmacy, Suite 3200 — Newark, Delaware, United States
- Christiana Care Health Services, Helen F. Graham Cancer Center — Newark, Delaware, United States
- Christiana Care Oncology Hematology, Helen F Graham Cancer Center, Suite 2400 — Newark, Delaware, United States
- Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer Center — Newark, Delaware, United States
- Christiana Care Health Services, Christiana Hospital — Newark, Delaware, United States
- Georgetown University Medical Center Department of Pharmacy, Research — Washington D.C., District of Columbia, United States
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
- Indiana CTSI Clinical Research Center (ICRC) — Indianapolis, Indiana, United States
- Indiana University Health Hospital — Indianapolis, Indiana, United States
- Indiana University Health Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
- Investigational Drug Services IUHSCC — Indianapolis, Indiana, United States
- Sidney &Lois Eskenazi Hospital — Indianapolis, Indiana, United States
- Spring Mill Medical Center — Indianapolis, Indiana, United States
- Siteman Cancer Center - Barnes St. Peters — City of Saint Peters, Missouri, United States
- Siteman Cancer Center - West County — Creve Coeur, Missouri, United States
- Siteman Cancer Center - North County — Florissant, Missouri, United States
- Center for Outpatient Health (Dermatology Clinic) — St Louis, Missouri, United States
- Center for Outpatient Health (Ophthalmology Clinic) — St Louis, Missouri, United States
- Barnes-Jewish Hospital — St Louis, Missouri, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Siteman Cancer Center - South County — St Louis, Missouri, United States
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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