Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine

Part of paid clinical trials in La Jolla, California.

Sponsor
Genocea Biosciences, Inc.
Study ID
NCT03633110
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • GEN-009 Adjuvanted Vaccine — BIOLOGICAL
    GEN-009 Adjuvanted Vaccine consists of GEN-009 Drug Product mixed with Hiltonol (poly-ICLC, adjuvant) and is administered by subcutaneous injection.
  • Nivolumab — DRUG
    Nivolumab is a PD-1 checkpoint inhibitor approved by the FDA to treat the tumor types in this study.
  • Pembrolizumab — DRUG
    Pembrolizumab is a PD-1 checkpoint inhibitor approved by the FDA to treat the tumor types in this study.

Study Details

In this study, Genocea is evaluating an investigational, personalized adjuvanted vaccine, GEN-009, that is being developed for the treatment of patients with solid tumors. A proprietary tool developed by Genocea, called ATLAS™ (Antigen Lead Acquisition System) will be used to identify neoantigens in each patient's tumor that are recognized by their CD4 and/or CD8 T cells. ATLAS-identified neoantigens will then be incorporated into a patient's personalized vaccine in the form of synthetic long peptides (SLPs).

Key Dates

Start date
Aug 29, 2018
Status verified
Apr 2022
Primary completion
Dec 8, 2021
Completion
Feb 28, 2022

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part A
    Participants in Part A have no evidence of disease when they begin receiving GEN-009 Adjuvanted Vaccine, and have completed treatment with curative intent for their disease (eg, surgical resection, neoadjuvant and/or adjuvant chemotherapy, and/or radiation therapy). Part A will consist of approximately 9 participants.
  • Experimental: Part B
    Participants in Part B have advanced or metastatic solid tumors, and will receive GEN-009 Adjuvanted Vaccine in combination with PD-1 inhibitor therapy (nivolumab or pembrolizumab). Part B will consist of up to 90 participants.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [ Time Frame: 1.5 years after first GEN-009 vaccination ]

Locations (11)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
John Wayne Cancer Institute - Providence Saint John's Health CenterSanta MonicaCalifornia90404-
University of Colorado, Anschutz Cancer PavilionAuroraColorado80045-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Karmanos Cancer InstituteDetroitMichigan48201-
University of Nebraska Medical CenterOmahaNebraska68198-
Columbia University Medical Center - Herbert Irving PavilionNew YorkNew York10032-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
The Sarah Cannon Research InstituteNashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-

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UC San Diego Moores Cancer Center· La Jolla, CAJohn Wayne Cancer Institute - Providence Saint John's Health Center· Santa Monica, CAUniversity of Colorado, Anschutz Cancer Pavilion· Aurora, CODana-Farber Cancer Institute· Boston, MAKarmanos Cancer Institute· Detroit, MIUniversity of Nebraska Medical Center· Omaha, NE

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