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Clinical Trials in the USA / NCT05141721
Active, not recruiting Phase 2/3

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

NCT05141721 · tracked via the Priya Life Science USA tracker
Sponsor
Seattle Project Corporation
Phase
Phase 2/3
Started
2022-02-12
Last updated
2025-05-16

Condition(s) studied

Colorectal Neoplasms

Investigational drug(s) / intervention(s)

GRT-C901GRT-R902AtezolizumabIpilimumabFluoropyrimidine plus leucovorinBevacizumab

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.

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.

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

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.

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

Bevacizumab: Bevacizumab administered as maintenance therapy per standard of care.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (43)

FacilityCityRegionStatus
Banner MD Anderson Gilbert Arizona
Highlands Oncology Springdale Arkansas
U.S.C Norris Cancer Center, Keck School of Medicine, Division of Medical Oncology Los Angeles California
University of California - Irvine (UCI) Orange California
University of California Los Angeles (UCLA) Santa Monica California
Rocky Mountain Cancer Centers - USOR Denver Colorado
Eastern CT Hematology and Oncology Associates (ECHO) Norwich Connecticut
Lynn Cancer Institute - Boca Raton Regional Hospital Boca Raton Florida
University of Miami Miami Florida
Miami Cancer Institute at Baptist Health South Florida (USOR site) Miami Florida
Mount Sinai Comprehensive Cancer Center Miami Beach Florida
Orlando Health Orlando Florida
Advanced Research (Oncology & Hemotology Associates of West Broward) Tamarac Florida
University of Illinois at Chicago Chicago Illinois
University of Chicago Chicago Illinois
Indiana University Indianapolis Indiana
University of Kansas Medical Center Fairway Kansas
Norton Cancer Institute Louisville Kentucky
American Oncology Partners of Maryland, PA Bethesda Maryland
Barbara Ann Karmanos Cancer Institute Detroit Michigan
Comprehensive Cancer Centers of Nevada Las Vegas Nevada
Astera Cancer Care East Brunswick New Jersey
Summit Health Florham Park New Jersey
Morristown Medical Center Morristown New Jersey
Rutgers New Brunswick New Jersey
NYU Langone Health New York New York
Columbia University Irving Medical Center New York New York
New York Cancer and Blood Port Jefferson Station New York
Christ Hospital Cancer Center Cincinnati Ohio
Northwest Cancer Specialists DBA Compass Oncology - USOR Portland Oregon
Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia Pennsylvania
Allegheny General Hospital Pittsburgh Pennsylvania
Prisma Health Greenville South Carolina
Tennessee Oncology - Sarah Cannon Research Institute Nashville Tennessee
Vanderbilt University Medical Center Nashville Tennessee
Texas Oncology PA - USOR Austin Texas
Texas Oncology - Dallas Sammons Dallas Texas
MD Anderson Houston Texas
Baylor Scott and White Temple Texas
Huntsman Cancer Institute at University of Utah Salt Lake City Utah

+ 3 more sites — see the full list on the official registry below.

On this site

📄 Tecentriq (atezolizumab) drug profile → 📄 Avastin (bevacizumab) drug profile →

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05141721 on ClinicalTrials.gov ↗ ← All trials in the USA