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).
This first-in-human study of GEN-009 will be conducted in two parts in adult patients with cutaneous melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma, or renal cell carcinoma (Part B only). In Part A, the safety and immunogenicity of single-agent GEN-009 will be evaluated in patients with the above-noted tumor types who have completed treatment with curative intent for their disease (eg, surgical resection, neoadjuvant and/or adjuvant chemotherapy, and/or radiation therapy) and have no evidence of disease (NED) at the time of initiating vaccination with GEN-009. In Part B, up to 15 patients in each disease cohort will be enrolled and evaluated for safety, immunogenicity, and preliminary antitumor activity of GEN-009. Patients in Part B will receive GEN-009 at the schedule selected in Part A, in combination with a PD-1 inhibitor therapy (nivolumab or pembrolizumab) at the approved dose and schedule per the United States Package Insert (USPI). In addition, up to 15 patients who enroll in one of the Part B disease-specific cohorts but whose disease progresses during the screening period therapy may be enrolled into a separate relapsed/refractory disease cohort.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
UC San Diego Moores Cancer Center
La Jolla, California, United States
John Wayne Cancer Institute - Providence Saint John's Health Center
Santa Monica, California, United States
University of Colorado, Anschutz Cancer Pavilion
Aurora, Colorado, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
...and 1 more locations
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
Time frame: 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
Time frame: 1.5 years after first GEN-009 vaccination
Antitumor activity of GEN-009 in Part B
Evaluation conducted based on RECIST v1.1 (and immune-related RECIST \[irRECIST\], where appropriate)
Time frame: 48 weeks after first GEN-009 vaccination
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