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

Running, not enrolling · Phase 2/Phase 3

Conditions studied: Colorectal Neoplasms

In brief

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.

Key facts

Study ID

NCT05141721

Run by

Seattle Project Corporation

People needed

700

Starts

2022-02-12

Expected to finish

2027-03-01

Last updated by the study team

2025-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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