Study of DPX-Survivac Vaccine Therapy and Epacadostat in Patients With Recurrent Ovarian Cancer

Official Title

A Phase 1b/2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide and Epacadostat (INCB024360) in Patients With Recurrent Ovarian Cancer

Summary:

Immunotherapeutic survivin vaccine DPX-Survivac, low dose oral cyclophosphamide, and IDO1 inhibitor epacadostat will be tested together for the first time in patients with recurrent ovarian, fallopian tube, or peritoneal cancer to determine the safety and potential immune-modulating activity of the combination of these agents.

Trial Description

Primary Outcome:

• Safety as measured by adverse event reporting (CTCAE)
• Cell mediated immunity as measured by the antigen specific response in peripheral blood
• Evaluation of treatment-induced changes in tumour infiltrating lymphocytes
• Objective Response Rate (Phase 2 only)

Secondary Outcome:

• Objective Response Rate (for each treatment group)
• Duration of Response
• Time to Progression
• Overall Survival

The Phase 1b component is a multicentre, non-randomized, open label, uncontrolled, safety and effectiveness study to identify the recommended Phase 2 dose (R2PD) of epacadostat in combination with DPX-Survivac and cyclophosphamide. The Phase 2 component is a multicentre, randomized, open-label study to evaluate the safety and effectiveness of DPX-Survivac + cyclophosphamide with or without the RP2D of epacadostat.

View this trial on ClinicalTrials.gov