A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Gritstone bio, Inc.
Study ID
NCT03953235
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GRT-C903 — BIOLOGICAL
    a shared neoantigen cancer vaccine prime
  • GRT-R904 — BIOLOGICAL
    a shared neoantigen cancer vaccine boost
  • nivolumab — BIOLOGICAL
    anti-PD-1 monoclonal antibody
  • ipilimumab — BIOLOGICAL
    anti-CTLA-4 monoclonal antibody

Study Details

The purpose of this study is to evaluate the dose, safety, immunogenicity and early clinical activity of GRT-C903 and GRT-R904, a neoantigen-based therapeutic cancer vaccine, in combination with immune checkpoint blockade, in patients with advanced or metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, pancreatic cancer, and shared neoantigen-positive tumors. Based on the Phase 1 data, an updated vaccine candidate (SLATE-KRAS or version 2) was developed that removed 16 of the 20 mutations included in the original vaccine (version 1) and solely targets KRAS mutations.

Key Dates

Start date
Jul 18, 2019
Status verified
Sep 2023
Primary completion
Mar 10, 2023
Completion
Mar 10, 2023

Study Design

Enrollment
39 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1
    * GRT-C903 * GRT-R904 * nivolumab * ipilimumab
  • Experimental: Phase 2
    * GRT-C903 * GRT-R904 * nivolumab * ipilimumab Phase 2 for some patients includes a monthly or every two month treatment schedule

Primary Outcome Measure

Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs) [ Time Frame: Initiation of study treatment through 100 days post-last dose (up to approximately 27 months) ]

Locations (12)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054-
UCLA Medical CenterSanta MonicaCalifornia90404-
Mayo Clinic FloridaJacksonvilleFlorida32224-
University of Chicago Medicine, Comprehensive Cancer CenterChicagoIllinois60637-
Mayo Clinic RochesterRochesterMinnesota55905-
Columbia University Medical Center, Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Tennessee OncologyNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Phoenix, AZ

By condition
Colorectal cancerLung cancerPancreatic cancer
By specialty
OncologyGI oncologyLung oncologyLung disease
By research site
Mayo Clinic Arizona· Phoenix, AZUCLA Medical Center· Santa Monica, CAMayo Clinic Florida· Jacksonville, FLUniversity of Chicago Medicine, Comprehensive Cancer Center· Chicago, ILMayo Clinic Rochester· Rochester, MNColumbia University Medical Center, Herbert Irving Comprehensive Cancer Center· New York, NY

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