A Study of a Personalized Neoantigen Cancer Vaccine

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Gritstone bio, Inc.
Study ID
NCT03639714
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • GRT-C901 — BIOLOGICAL
    a patient-specific neoantigen cancer vaccine prime
  • GRT-R902 — BIOLOGICAL
    a patient-specific 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 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.

Key Dates

Start date
Feb 13, 2019
Status verified
Sep 2023
Primary completion
Nov 10, 2022
Completion
Nov 10, 2022

Study Design

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

Arms

  • Experimental: Phase 1
    * GRT-C901 * GRT-R902 * nivolumab * ipilimumab
  • Experimental: Phase 2 Cohorts
    * GRT-C901 * GRT-R902 * nivolumab * ipilimumab

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 (10)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054-
Mayo ClinicJacksonvilleFlorida32224-
The University of ChicagoChicagoIllinois60637-
Mayo ClinicRochesterMinnesota55905-
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10017-
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Tennessee OncologyNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Phoenix, AZ

By condition
Colorectal cancerLung cancerBladder cancer
By specialty
OncologyGI oncologyLung oncologyLung diseaseUrology
By research site
Mayo Clinic Arizona· Phoenix, AZMayo Clinic· Jacksonville, FLThe University of Chicago· Chicago, ILMayo Clinic· Rochester, MNColumbia University Medical Center· New York, NYMemorial Sloan Kettering Cancer Center· New York, NY

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