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ACTIVE NOT RECRUITING

NCT05141721

PHASE2/PHASE3

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

Sponsor: Seattle Project Corporation

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

700

Start Date

2022-02-12

Completion Date

2027-03

Last Updated

2025-05-16

Healthy Volunteers

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.

Inclusion Criteria: * 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. Exclusion Criteria: * Patients with deficient mismatch repair (dMMR) or microsatellite instability (MSI-H) phenotype * Patient has a known tumor mutation burden \<1 non-synonymous mutations/megabase * Known DNA Polymerase Epsilon mutations * Patients with known BRAFV600E mutations * Bleeding disorder or history of significant bruising or bleeding following IM injections or blood draws * Immunosuppression anticipated at time of study treatment * History of allogeneic tissue/solid organ transplant * Active or history of autoimmune disease or immune deficiency * Patient with symptomatic or actively progressing central nervous system (CNS) metastases, carcinomatous meningitis, or has been treated with whole brain radiation * History of other cancer within 2 years with the exception of neoplasm that has undergone potentially curative therapy * Any severe concurrent non-cancer disease that, in the judgment of the Investigator, would make the patient inappropriate for the current study * Active tuberculosis or recent (\<2 weeks) clinically significant infection, evidence of active hepatitis B or hepatitis C, or known history of positive test for HIV * History of pneumonitis requiring systemic steroids for treatment (with the exception of prior resolved in-field radiation pneumonitis) * Myocardial infarction within previous 3 months, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure (Class III or IV). * Pregnant, planning to become pregnant, or nursing.

Locations (43)

Banner MD Anderson

Gilbert, Arizona, United States

Highlands Oncology

Springdale, Arkansas, United States

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

Los Angeles, California, United States

University of California - Irvine (UCI)

Orange, California, United States

University of California Los Angeles (UCLA)

Santa Monica, California, United States

Rocky Mountain Cancer Centers - USOR

Denver, Colorado, United States

Eastern CT Hematology and Oncology Associates (ECHO)

Norwich, Connecticut, United States

Lynn Cancer Institute - Boca Raton Regional Hospital

Boca Raton, Florida, United States

University of Miami

Miami, Florida, United States

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

Miami, Florida, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Orlando Health

Orlando, Florida, United States

Advanced Research (Oncology & Hemotology Associates of West Broward)

Tamarac, Florida, United States

University of Illinois at Chicago

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Kansas Medical Center

Fairway, Kansas, United States

Norton Cancer Institute

Louisville, Kentucky, United States

American Oncology Partners of Maryland, PA

Bethesda, Maryland, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

Summit Health

Florham Park, New Jersey, United States

Morristown Medical Center

Morristown, New Jersey, United States

Rutgers

New Brunswick, New Jersey, United States

NYU Langone Health

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

New York Cancer and Blood

Port Jefferson Station, New York, United States

Christ Hospital Cancer Center

Cincinnati, Ohio, United States

Northwest Cancer Specialists DBA Compass Oncology - USOR

Portland, Oregon, United States

Sidney Kimmel Medical College at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Prisma Health

Greenville, South Carolina, United States

Tennessee Oncology - Sarah Cannon Research Institute

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Oncology PA - USOR

Austin, Texas, United States

Texas Oncology - Dallas Sammons

Dallas, Texas, United States

MD Anderson

Houston, Texas, United States

Baylor Scott and White

Temple, Texas, United States

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (43)