A Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

700

Participants

Timeline

Start Date

February 12, 2022

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2027

Conditions
Colorectal Neoplasms
Interventions
DRUG

GRT-C901

A patient-specific neoantigen cancer vaccine administered via intramuscular (IM) injection as prime and single boost at a dose of 1x10\^12 viral particles 2 times over the course of the first year.

DRUG

GRT-R902

A patient-specific neoantigen cancer vaccine boost, administered via IM injection at a dose of 30ug 4 times over the course of the first year.

DRUG

Atezolizumab

Atezolizumab will be administered via intravenous (IV) infusion at a dose of 1680 mg once every 4 weeks.

DRUG

Ipilimumab

Ipilimumab will be administered via subcutaneous (SC) injection at a dose of 30 mg with the first dose of GRT-C901 and GRT-R902.

DRUG

Fluoropyrimidine plus leucovorin

Fluoropyrimidine (infusional 5-FU or capecitabine) and leucovorin administered as maintenance therapy per standard of care.

DRUG

Bevacizumab

Bevacizumab administered as maintenance therapy per standard of care.

Trial Locations (43)

10016

NYU Langone Health, New York

10032

Columbia University Irving Medical Center, New York

11776

New York Cancer and Blood, Port Jefferson Station

15212

Allegheny General Hospital, Pittsburgh

19107

Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia

20817

American Oncology Partners of Maryland, PA, Bethesda

22031

Virginia Cancer Specialists, Fairfax

22903

University of Virginia, Charlottesville

29615

Prisma Health, Greenville

32806

Orlando Health, Orlando

33136

University of Miami, Miami

33140

Mount Sinai Comprehensive Cancer Center, Miami Beach

33176

Miami Cancer Institute at Baptist Health South Florida (USOR site), Miami

33321

Advanced Research (Oncology & Hemotology Associates of West Broward), Tamarac

33486

Lynn Cancer Institute - Boca Raton Regional Hospital, Boca Raton

37203

Tennessee Oncology - Sarah Cannon Research Institute, Nashville

37232

Vanderbilt University Medical Center, Nashville

40202

Norton Cancer Institute, Louisville

45229

Christ Hospital Cancer Center, Cincinnati

46202

Indiana University, Indianapolis

48201

Barbara Ann Karmanos Cancer Institute, Detroit

53226

Medical College of Wisconsin, Milwaukee

60607

University of Illinois at Chicago, Chicago

60637

University of Chicago, Chicago

66205

University of Kansas Medical Center, Fairway

72762

Highlands Oncology, Springdale

75246

Texas Oncology - Dallas Sammons, Dallas

76508

Baylor Scott and White, Temple

77030

MD Anderson, Houston

78705

Texas Oncology PA - USOR, Austin

80218

Rocky Mountain Cancer Centers - USOR, Denver

84112

Huntsman Cancer Institute at University of Utah, Salt Lake City

85234

Banner MD Anderson, Gilbert

89119

Comprehensive Cancer Centers of Nevada, Las Vegas

90033

U.S.C Norris Cancer Center, Keck School of Medicine, Division of Medical Oncology, Los Angeles

90404

University of California Los Angeles (UCLA), Santa Monica

92697

University of California - Irvine (UCI), Orange

97227

Northwest Cancer Specialists DBA Compass Oncology - USOR, Portland

06360

Eastern CT Hematology and Oncology Associates (ECHO), Norwich

08816

Astera Cancer Care, East Brunswick

07932

Summit Health, Florham Park

07960

Morristown Medical Center, Morristown

08903

Rutgers, New Brunswick

All Listed Sponsors
lead

Seattle Project Corporation

INDUSTRY