Study of Binimetinib + Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation

Part of paid clinical trials in Los Angeles, California.

Sponsor
Pfizer
Study ID
NCT03271047
Phase
PHASE2
Status
Completed

Conditions

  • MSS
  • RAS-mutant Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • binimetinib — DRUG
    Orally, twice daily.
  • nivolumab — DRUG
    Intravenously (IV) every 4 weeks (Q4W)
  • ipilimumab — DRUG
    intravenously (IV) every 8 weeks (Q8W)

Study Details

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 Dates

Start date
Oct 18, 2017
Status verified
Dec 2021
Primary completion
Oct 13, 2020
Completion
Feb 25, 2021

Study Design

Enrollment
75 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b / Arm 1A
    binimetinib + nivolumab
  • Experimental: Phase 1b / Arm 1B
    binimetinib + nivolumab + ipilimumab
  • Experimental: Phase 2 / Arm 2A
    binimetinib + nivolumab
  • Experimental: Phase 2 / Arm 2B
    binimetinib + nivolumab + ipilimumab

Primary Outcome Measure

Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) [ Time Frame: Cycle 1: Day 1 up to Day 28 ]

Locations (33)

FacilityCityStateZIPSite coordinators
UCLA Hematology/OncologyLos AngelesCalifornia90095-
UCLA Hematology/Oncology - Santa MonicaSanta MonicaCalifornia90404-
Christiana Care Health Services, Christiana HospitalNewarkDelaware19718-
Christiana Care Health Services, Helen F. Graham Cancer CenterNewarkDelaware19713-
Christiana Care Health Services, Helen F. Graham Cancer Center Pharmacy, Suite 3200NewarkDelaware19713-
Christiana Care Oncology Hematology, Helen F Graham Cancer Center, Suite 2400NewarkDelaware19713-
Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer CenterNewarkDelaware19713-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Georgetown University Medical Center Department of Pharmacy, ResearchWashington D.C.District of Columbia20007-
Hematology Oncology Associates of the Treasure CoastPort Saint LucieFlorida34952-
Indiana CTSI Clinical Research Center (ICRC)IndianapolisIndiana46202-
Indiana University Health HospitalIndianapolisIndiana46202-
Indiana University Health Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Investigational Drug Services IUHSCCIndianapolisIndiana46202-
Sidney &Lois Eskenazi HospitalIndianapolisIndiana46202-
Spring Mill Medical CenterIndianapolisIndiana46290-
Siteman Cancer Center - Barnes St. PetersCity of Saint PetersMissouri63376-
Siteman Cancer Center - West CountyCreve CoeurMissouri63141-
Siteman Cancer Center - North CountyFlorissantMissouri63031-
Barnes-Jewish HospitalSt LouisMissouri63110-
Center for Outpatient Health (Dermatology Clinic)St LouisMissouri63108-
Center for Outpatient Health (Ophthalmology Clinic)St LouisMissouri63108-
Siteman Cancer Center - South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Investigational Drug Service of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Sarah Cannon Research InstituteChattanoogaTennessee37404-
SCRI Tennessee Oncology ChattanoogaChattanoogaTennessee37404-
Tennessee Oncology, PLLCClevelandTennessee37311-
Tennessee Oncology NASH - SCRI - PPDSNashvilleTennessee37203-
The Sarah Cannon Research Institute.NashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
UCLA Hematology/Oncology· Los Angeles, CAUCLA Hematology/Oncology - Santa Monica· Santa Monica, CAChristiana Care Health Services, Christiana Hospital· Newark, DEChristiana Care Health Services, Helen F. Graham Cancer Center· Newark, DEChristiana Care Health Services, Helen F. Graham Cancer Center Pharmacy, Suite 3200· Newark, DEChristiana Care Oncology Hematology, Helen F Graham Cancer Center, Suite 2400· Newark, DE

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