A Study of a Personalized Neoantigen Cancer Vaccine

Last updated: September 11, 2023
Sponsor: Gritstone bio, Inc.
Overall Status: Completed

Phase

1/2

Condition

Colorectal Cancer

Urothelial Carcinoma

Colon Cancer; Rectal Cancer

Treatment

ipilimumab

GRT-C901

nivolumab

Clinical Study ID

NCT03639714
GO-004
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provide a signed and dated informed consent form prior to initiation of study-specificprocedures.
  • Patients with the indicated advanced or metastatic solid tumor as follows:
  1. NSCLC who are planned for or have received no more than 1 cycle of systemictreatment with cytotoxic, platinum-based chemotherapy (note: patients who havereceived anti-PD-(L)1 monotherapy are eligible)
  2. GEA who are planned for or have received no more than 1 cycle of systemictreatment with cytotoxic, platinum-based chemotherapy
  3. mUC who are planned for or have received no more than 1 cycle of systemictreatment with cytotoxic, platinum-based chemotherapy
  4. CRC-MSS who are receiving first line systemic therapy or who are planned for orhave received no more than 1 cycle of second line systemic therapy including afluoropyrimidine and oxaliplatin or irinotecan
  • 18 years of age or older
  • ECOG Performance Status 0 or 1
  • Lesion amenable to biopsy
  • Measurable disease according to RECIST v1.1
  • Have adequate organ function, as measured by laboratory values (criteria listed inprotocol)

Exclusion

Exclusion Criteria:

  • Tumors with genetic characteristics as follows:
  1. For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1,RET, or TRK
  2. For CRC and GEA, patients with known MSI-high disease based on institutionalstandard
  3. For CRC, patients with a known BRAF V600E mutation or patients with peritonealcarcinomatosis and for GEA, patients with peritoneal carcinomatosis as their onlyevidence of disease
  • Patients with known central nervous system (CNS) metastases and/or carcinomatousmeningitis
  • Known exposure to chimpanzee adenovirus or any history of anaphylaxis in reaction to avaccination or allergy or hypersensitivity to study drug components
  • Bleeding disorder (eg., factor deficiency, coagulopathy) or history of significantbruising or bleeding following IM injections or blood draws Complete inclusion and exclusion criteria are listed in the clinical study protocol.

Study Design

Total Participants: 29
Treatment Group(s): 4
Primary Treatment: ipilimumab
Phase: 1/2
Study Start date:
February 13, 2019
Estimated Completion Date:
November 10, 2022

Study Description

Tumors harboring non-synonymous deoxyribonucleic acid (DNA) mutations can present peptides containing these mutations as non-self antigens in the context of HLA 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 safety and early clinical activity of this patient-specific immunotherapy intended to induce T-cell responses specific for neoantigens.

Connect with a study center

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Mayo Clinic Arizona

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • The University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10017
    United States

    Site Not Available

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

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