Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by May Cho, MD

Description

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 in combination with checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone as assessed by changes in circulating tumor (ct)DNA. The primary objective of the Phase 3 portion is to demonstrate clinical efficacy of the regime 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

Details

Tumors harboring non-synonymous deoxyribonucleic acid (DNA) mutations can present peptides containing these mutations as non-self antigens in the context of human leukocyte antigens (HLAs) on the tumor cell surface. A fraction of mutated peptides result in neoantigens capable of generating T-cell responses that exclusively target tumor cells. Sensitive detection of these mutations allows for the identification of neoantigens unique to each patient's tumor to be included in a personalized cancer vaccine that targets these neoantigens. This vaccine regimen uses two vaccine vectors as a heterologous prime/boost approach (GRT-C901 first followed by GRT-R902) to stimulate an immune response. This study will explore the anti-tumor activity of this patient-specific immunotherapy in combination with checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab.

Keywords

Colorectal Neoplasms Colorectal cancer vaccine Bevacizumab Ipilimumab Oxaliplatin Atezolizumab GRT-C901 GRT-R902 Fluoropyrimidine

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients with histologically confirmed metastatic colorectal cancer (CRC) who are planned for, or have received no more than 1 cycle of first-line treatment in the metastatic setting with a fluoropyrimidine and oxaliplatin in combination with bevacizumab
  • Measurable and unresectable 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 in opinion of investigator
  • 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 CAN'T join if...

  • Patients with deficient mismatch repair (dMMR) or high levels of 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
  • Pregnant, planning to become pregnant, or nursing.

Locations

  • University of California - Irvine (UCI) not yet accepting patients
    Orange California 92697 United States
  • U.S.C Norris Cancer Center, Keck School of Medicine, Division of Medical Oncology accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at UC Irvine

  • May Cho, MD
    Associate Clinical Professor, Medicine, School of Medicine

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Gritstone bio, Inc.
ID
NCT05141721
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 665 study participants
Last Updated