Study of DPX-Survivac Therapy 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:

T cell activating therapy 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)
• Objective Response Rate (Phase 2 only)

Secondary Outcome:

• Objective Response Rate (for each treatment group)
• Duration of Response
• Cell mediated immunity as measured by the antigen specific response in peripheral blood
• Evaluation of treatment-induced changes in tumour infiltrating lymphocytes
• 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 was initially a multicentre, randomized, open-label study to evaluate the safety and effectiveness of DPX-Survivac + cyclophosphamide with or without the RP2D of epacadostat. The design of the study has been amended to a single arm study in which up to 16 evaluable subjects will be enrolled to received DPX-Survivac plus intermittent low dose cyclophosphamide (i.e. treatment arm 2).

View this trial on ClinicalTrials.gov