A Phase 2/3, Randomized, Open-Label Study of Maintenance GRT-C901/GRT-R902, A Neoantigen Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer
Status: Active_not_recruiting
Location: See all (43) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The primary objective of the Phase 2 portion of the study is to characterize the clinical activity of maintenance therapy with GRT-C901/GRT-R902 (patient-specific vaccines) in combination with checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus a fluoropyrimidine/bevacizumab alone as assessed by molecular response which is based on changes in circulating tumor (ct)DNA. The primary objective of the Phase 3 portion is to demonstrate clinical efficacy of the regimen as assessed by progression-free survival.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients with histologically confirmed metastatic colorectal cancer (CRC) who are planned for, or have received \<30 days of first-line treatment in the metastatic setting with FOLFOX/bev, CAPEOX/bev, FOLFOXIRI/bev, or CAPOXIRI/bev per SOC
• Measurable and unresectable metastatic disease according to RECIST v1.1
• Availability of formalin-fixed paraffin-embedded (FFPE) tumor specimens.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Patient has adequate organ function per defined criteria
• If women of childbearing potential (WCBP), must be willing to undergo pregnancy testing and agrees to the use at least 1 highly effective contraceptive method during the study treatment period and for 150 days after last investigational study treatment.
Locations
United States
Arkansas
Highlands Oncology
Springdale
Arizona
Banner MD Anderson
Gilbert
California
U.S.C Norris Cancer Center, Keck School of Medicine, Division of Medical Oncology
Los Angeles
University of California - Irvine (UCI)
Orange
University of California Los Angeles (UCLA)
Santa Monica
Colorado
Rocky Mountain Cancer Centers - USOR
Denver
Connecticut
Eastern CT Hematology and Oncology Associates (ECHO)
Norwich
Florida
Lynn Cancer Institute - Boca Raton Regional Hospital
Boca Raton
Miami Cancer Institute at Baptist Health South Florida (USOR site)
Miami
University of Miami
Miami
Mount Sinai Comprehensive Cancer Center
Miami Beach
Orlando Health
Orlando
Advanced Research (Oncology & Hemotology Associates of West Broward)
Tamarac
Illinois
University of Chicago
Chicago
University of Illinois at Chicago
Chicago
Indiana
Indiana University
Indianapolis
Kansas
University of Kansas Medical Center
Fairway
Kentucky
Norton Cancer Institute
Louisville
Maryland
American Oncology Partners of Maryland, PA
Bethesda
Michigan
Barbara Ann Karmanos Cancer Institute
Detroit
New Jersey
Astera Cancer Care
East Brunswick
Summit Health
Florham Park
Morristown Medical Center
Morristown
Rutgers
New Brunswick
Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
New York
Columbia University Irving Medical Center
New York
NYU Langone Health
New York
New York Cancer and Blood
Port Jefferson Station
Ohio
Christ Hospital Cancer Center
Cincinnati
Oregon
Northwest Cancer Specialists DBA Compass Oncology - USOR
Portland
Pennsylvania
Sidney Kimmel Medical College at Thomas Jefferson University
Philadelphia
Allegheny General Hospital
Pittsburgh
South Carolina
Prisma Health
Greenville
Tennessee
Tennessee Oncology - Sarah Cannon Research Institute
Nashville
Vanderbilt University Medical Center
Nashville
Texas
Texas Oncology PA - USOR
Austin
Texas Oncology - Dallas Sammons
Dallas
MD Anderson
Houston
Baylor Scott and White
Temple
Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City
Virginia
University of Virginia
Charlottesville
Virginia Cancer Specialists
Fairfax
Wisconsin
Medical College of Wisconsin
Milwaukee
Time Frame
Start Date:2022-02-12
Completion Date:2027-03
Participants
Target number of participants:700
Treatments
Experimental: Vaccine Arm
After receiving up to 24 weeks induction therapy with a fluoropyrimidine/oxaliplatin/bevacizumab (with or without irinotecan), per standard of care and after completing vaccine production screening, patients will receive a total of 6 administrations of GRT-C901/GRT-R902 plus ipilimumab co-administered only with the first dose of GRT-C901 and GRT-R902. All patients will receive atezolizumab in addition to maintenance therapy of a fluoropyrimidine and bevacizumab according to standard of care.
Active_comparator: Control Arm
After receiving up to 24 weeks induction therapy with a fluoropyrimidine/oxaliplatin/bevacizumab (with or without irinotecan), per standard of care and undergoing vaccine production screening, patients will receive maintenance therapy of a fluoropyrimidine and bevacizumab according to standard of care.