Spots Global Cancer Trial Database for Study of Binimetinib + Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation
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Trial Identification
Brief Title: Study of Binimetinib + Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation
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
Study ID: NCT03271047
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, District of Columbia, United States
Georgetown University Medical Center, Washington, 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 - West County, Creve Coeur, Missouri, United States
Siteman Cancer Center - North County, Florissant, Missouri, United States
Center for Outpatient Health (Dermatology Clinic), Saint Louis, Missouri, United States
Center for Outpatient Health (Ophthalmology Clinic), Saint Louis, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center - South County, Saint Louis, Missouri, United States
Siteman Cancer Center - Barnes St. Peters, Saint Peters, Missouri, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Investigational Drug Service of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, Chattanooga, Tennessee, United States
SCRI Tennessee Oncology Chattanooga, Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC, Cleveland, Tennessee, United States
Tennessee Oncology NASH - SCRI - PPDS, Nashville, Tennessee, United States
The Sarah Cannon Research Institute., Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
UZ Leuven - Dermatology, Leuven, , Belgium
UZ Leuven - Ophthalmology, Leuven, , Belgium
UZ Leuven, Leuven, , Belgium
The Netherlands Cancer Institute Antoni Van Leeuwenhoek, Amsterdam, Noord-holland, Netherlands
OLVG locatie Oost, Amsterdam, Noord-holland, Netherlands
Amsterdam Medical Center (AMC), Amsterdam, Noord-holland, Netherlands
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Vall d'Hebrón - PPDS, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Clinica Rementeria, MAdrid, , Spain
Hospital Universitario 12 Octubre, Madrid, , Spain
Hospital HM Universitario Sanchinarro, CIOCC, Madrid, , Spain
Royal Marsden Hospital - London, London, London, CITY OF, United Kingdom
Churchill Hospital, Oxford, Oxfordshire, United Kingdom
Royal Marsden Hospital NHS Foundation Trust, Surrey, Sutton, United Kingdom
Royal Marsden Hospital NHS Foundation Trust, London, , United Kingdom
Royal Marsden Hospital -Fulham Road, London, , United Kingdom
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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