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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Stanford University
Palo Alto, California, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
Lenox Hill Hospital
New York, New York, United States
Oregon Health & Sciences University, Knight Cancer Institute
Safety as measured by adverse event reporting (CTCAE)
Time frame: up to 13 months
Objective Response Rate (Phase 2 only)
Evaluated using modified RECIST v1.1
Time frame: up to 13 months
Objective Response Rate (for each treatment group)
Evaluated using modified RECIST v1.1
Time frame: up to 13 months
Duration of Response
Time frame: up to 13 months
Cell mediated immunity as measured by the antigen specific response in peripheral blood
Time frame: bimonthly for up to 13 months
Evaluation of treatment-induced changes in tumor infiltrating lymphocytes
Time frame: at 8 to 10 weeks
Time to Progression
Time frame: up to 13 months
Overall Survival
Time frame: up to 13 months
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Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Mary Crowley Cancer Research Center
Dallas, Texas, United States
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada