Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GEN-009 Adjuvanted Vaccine · 1 trial · 5 indications
Adverse events will be graded according to the NC Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Immunogenicity based on T-cell responses to GEN-009
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | 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. |
| Part B | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
General Inclusion Criteria: * 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 al...