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Neoantigen DNA vaccine · 1 trial · 1 indication
-Safety and tolerability will be measured by National Cancer Institute Common Terminology Criteria (NCI CTCAE) v 5.0
-Feasibility is defined as the ability to produce a vaccine for 80% of patients enrolled within 24 weeks of the start of consolidation durvalumab.
| Arm | Type | Description |
|---|---|---|
| Neoantigen DNA vaccine+durvalumab | EXPERIMENTAL | * Patients will receive durvalumab (1500mg Q3W) in combination with standard of care carboplatin and etoposide for a total of 4 cycles given every 3 weeks * Beginning 4 weeks following Cycle 4 of carboplatin/etoposide/durvalumab, patients on will then receive 6 cycles of durvalumab 1500 mg with the polyepitope neoantigen DNA vaccine, both administered once every 4 weeks * Patients may then receive durvalumab every 4 weeks until disease progression or drug toxicity * Should a delay in vaccine preparation occur, patients will begin durvalumab and the vaccine will be added with the subsequent cycle. |
| Name | Type | Description |
|---|---|---|
| Neoantigen DNA vaccine | BIOLOGICAL | All study injections will be given intramuscularly using an integrated electroporation device (TDS-IM system, PapiVax Biotech). At each vaccination time point, patients will receive two injections of the neoantigen DNA vaccine, one injection into each deltoid or lateralis. |
| Durvalumab | DRUG | -Supplied by AstraZeneca |
| TDS-IM v2.0 Device | DEVICE | -Integrated electroporation administration system |
| Peripheral blood draws | PROCEDURE | -Pre-treatment, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Vaccine Day 1, Vaccine Day 29, Vaccine Day 85, Vaccine Day 141, on even numbers of cycles for durvalumab for one year following completion of vaccine |
Inclusion Criteria: * Histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) * Considered suitable to receive a platinum-based chemotherapy regimen with durvalumab as 1st line treatment for ES-SCLC. * Measurable disease defined as lesions that can be accurately m...