Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine
A Phase 1/2a Study to Evaluate the Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine in Adult Patients With Selected Solid Tumors
1 other identifier
interventional
24
1 country
11
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2018
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2018
CompletedFirst Posted
Study publicly available on registry
August 16, 2018
CompletedStudy Start
First participant enrolled
August 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedApril 19, 2022
April 1, 2022
3.3 years
August 6, 2018
April 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Treatment-Emergent Adverse Events
Adverse events will be graded according to the NC Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
1.5 years after first GEN-009 vaccination
T-cell responses to GEN-009 adjuvanted vaccine
Immunogenicity based on T-cell responses to GEN-009
1.5 years after first GEN-009 vaccination
Secondary Outcomes (1)
Antitumor activity of GEN-009 in Part B
48 weeks after first GEN-009 vaccination
Other Outcomes (4)
Long-term clinical outcomes of Part A participants
1.5 years after first GEN-009 vaccination
Additional cellular responses after vaccination with GEN-009
1 year after first GEN-009 vaccination
Phenotype of circulating immune cells after vaccination with GEN-009
1 year after first GEN-009 vaccination
- +1 more other outcomes
Study Arms (2)
Part A
EXPERIMENTALParticipants 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.
Part B
EXPERIMENTALParticipants 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.
Interventions
GEN-009 Adjuvanted Vaccine consists of GEN-009 Drug Product mixed with Hiltonol (poly-ICLC, adjuvant) and is administered by subcutaneous injection.
Nivolumab is a PD-1 checkpoint inhibitor approved by the FDA to treat the tumor types in this study.
Pembrolizumab is a PD-1 checkpoint inhibitor approved by the FDA to treat the tumor types in this study.
Eligibility Criteria
You may qualify if:
- Diagnosis of 1 of the following tumor types:
- Melanoma (cutaneous).
- NSCLC.
- SCCHN (oral, oropharyngeal, hypopharyngeal, or laryngeal).
- Urothelial carcinoma.
- Renal cell carcinoma (Part B only).
- Understand the study, be willing to comply with all study procedures and sign the informed consent
- Adequate tumor tissue available
- ECOG performance status of 0 or 1
- Negative pregnancy test (females of childbearing potential)
- Agree to use of contraception during the study until at least 90 days after final GEN-009 dose
- Adequate hematologic, liver, and kidney function
- Have completed or will complete treatment for their disease with curative intent
- Have no evidence of disease
- Receiving or will initiate treatment with nivolumab or pembrolizumab per disease as listed below:
- +13 more criteria
You may not qualify if:
- Received a live vaccine ≤ 28 days, or a non-live vaccine ≤ 14 days, prior to the first dose of GEN-009
- Acute or chronic skin disorders that would interfere with injection
- Receiving immunosuppressive therapies or systemic corticosteroids. Note: Use of topical corticosteroids or inhaled corticosteroids is acceptable
- Allergy to the vaccine adjuvant Hiltonol (poly-ICLC)
- Active hepatitis B or hepatitis C infection
- HIV Positive
- History of clinically significant cardiac condition
- History of leptomeningeal carcinomatosis
- Had clinically active immune-mediated disease within 5 years
- Received a prior allogeneic stem cell transplant
- Has primary immune deficiency
- Received a prior solid organ transplant
- Has malignant disease, other than the tumor types being treated in this study
- Female patient who is pregnant, breastfeeding, or who plans to become pregnant from the signing of the informed consent until ≥ 90 days from last dose of GEN-009
- Any condition that in the judgment of the PI would make the patient inappropriate for enrollment in the study
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
John Wayne Cancer Institute - Providence Saint John's Health Center
Santa Monica, California, 90404, United States
University of Colorado, Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, 10032, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Arthur P. DeCillis, MD
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2018
First Posted
August 16, 2018
Study Start
August 29, 2018
Primary Completion
December 8, 2021
Study Completion
February 28, 2022
Last Updated
April 19, 2022
Record last verified: 2022-04