Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine
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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Apr 19, 2022 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Genocea Biosciences, Inc.
- Interventions being studied
- Biological: GEN-009 Adjuvanted Vaccine; Drug: Nivolumab; Drug: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- General
- Diagnosis of 1 of the following tumor types: 1. Melanoma (cutaneous). 2. NSCLC. 3. SCCHN (oral, oropharyngeal, hypopharyngeal, or laryngeal). 4. Urothelial carcinoma. 5. 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 Part A-specific Inclusion:
- Have completed or will complete treatment for their disease with curative intent
- Have no evidence of disease Part B-specific Inclusion:
- Receiving or will initiate treatment with nivolumab or pembrolizumab per disease as listed below: 1. NSCLC: Patients with metastatic non-squamous NSCLC beginning first-line pembrolizumab in combination with pemetrexed and platinum chemotherapy, or metastatic squamous NSCLC beginning first-line pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel 2. SCCHN: Patients beginning pembrolizumab with recurrent or metastatic SCCHN with disease progression on or after a platinum-based therapy, or beginning first-line pembrolizumab for recurrent or metastatic SCCHN if tumors express PD-L1 with a Combined Positive Score (CPS) ≥ 1. 3. Cutaneous Melanoma: Patients with unresectable or metastatic cutaneous melanoma beginning nivolumab monotherapy or nivolumab in combination with ipilimumab. 4. Urothelial Carcinoma: Patients with locally advanced or metastatic urothelial carcinoma who are beginning pembrolizumab who: 1. Are not eligible for cisplatin-containing chemotherapy, and tumor is PD-L1 positive with CPS ≥ 10, or are not eligible for any platinum-containing chemotherapy, OR 2. Have had disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. 5. Renal Cell Carcinoma: 1. Patients with advanced RCC who have received prior anti-angiogenic therapy, and are beginning nivolumab monotherapy, OR 2. Untreated patients with intermediate or poor risk RCC based on the IMDC score who are beginning nivolumab in combination with ipilimumab.
- Disease assessment by CT or MRI
- Have at least 1 lesion that is measureable by RECIST 1.1
- Agree to a tumor biopsy 50 days after first GEN-009 vaccination
- Participants with hypothyroidism must be on thyroid replacement treatment General
- 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
- Patient has received cytotoxic chemotherapy within 4 weeks of the first leukapheresis Part A-specific
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UC San Diego Moores Cancer CenterLa Jolla, California
- John Wayne Cancer Institute - Providence Saint John's Health CenterSanta Monica, California
- University of Colorado, Anschutz Cancer PavilionAurora, Colorado
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Karmanos Cancer InstituteDetroit, Michigan
- University of Nebraska Medical CenterOmaha, Nebraska
- Columbia University Medical Center - Herbert Irving PavilionNew York, New York
- Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania
- The Sarah Cannon Research InstituteNashville, Tennessee
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- University of Wisconsin Carbone Cancer CenterMadison, Wisconsin
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 19, 2022. Always confirm current availability with the study team.