NCT02785250

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.) · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Phase 1b component is a multicenter, 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 multicenter, 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).

Conditions

• Recurrent Epithelial Ovarian Cancer
• Recurrent Fallopian Tube Cancer
• Recurrent Peritoneal Cancer

Interventions

Type	Name	Description
OTHER	DPX-Survivac	SubQ injection
DRUG	Cyclophosphamide	PO BID
DRUG	Epacadostat (INCB024360)	PO BID

Timeline

• Start date: 2016-04-01
• Primary completion: 2020-10-01
• Completion: 2025-05-01
• First posted: 2016-05-27
• Last updated: 2021-06-18

Locations

9 sites across 2 countries: United States, Canada