Safety and Efficacy of CRS-207 With Epacadostat in Platinum Resistant Ovarian, Fallopian or Peritoneal Cancer

Phase 1: Number of Subjects Reporting Hematologic and/or Non-hematologic Dose-limiting Toxicity (DLT)

Count of subjects in the Phase 1 cohorts who reported a hematologic and/or non-hematologic DLT. Non-hematological DLTs are defined as follows, excluding the safety events specified for exemption in Section 5.3.1 of the study protocol: * any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes that occurs during the DLT observation period (Cycle 1) and is Grade 3 or higher according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4; * any use of systemic steroids; and/or * a study drug dose interruption lasting ≥ 7 days for an adverse event with an unclear relationship to study drug. Hematological DLTs are defined as: * Grade 4 neutropenia lasting \>7 days; * Grade ≥3 febrile neutropenia; * Grade 4 anemia; * Grade 4 thrombocytopenia or ≥ Grade 3 thrombocytopenia lasting \>7 days or associated with bleeding; and/or * Dose delay \>7 days secondary to myelosuppression.

Time frame: Subjects followed for DLTs for 21 days following the first dose of CRS-207 (treatment Cycle 1 for CRS-207).

Phase 1: Adverse Events (AEs) by CTCAE Grade 3 or Higher

Count of subjects in the Phase 1 cohorts with incidences of CTCAE Grade 3 or higher AEs.

Time frame: Subjects followed from the start of study treatment until 30 days following the final dose of study drug, an average of 3 months.

Phase 2: Adverse Events (AEs)

Count of subjects in the Phase 2 cohorts with incidences of AEs.

Time frame: Subjects followed from the start of study treatment until 30 days following the final dose of study drug, an average of 2 months.

Phase 2: Objective Response Rate (ORR)

ORR was evaluated for Phase 2 subjects based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each assessed subject as measured by modified response evaluation criteria in solid tumors (mRECIST) and given the following hierarchy of overall response results: complete response (CR) \> partial response (PR) \> stable disease (SD) \> progressive disease (PD) \> not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR mRECIST values of CR, PR, SD, PD, and NE are provided for this outcome measure.

Time frame: BOR was assessed from the first dose of study treatment until documented disease progression, initiation of a new cancer treatment, death, or study termination, whichever comes first, assessed up to 20 weeks.

Phase 2: Progression Free Survival (PFS)

Number of weeks from the date of first dose of study treatment to the first date of objectively determined progressive disease (PD) or death from any cause, estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). PD is determined by mRECIST.

Time frame: Subjects followed for disease progression from first dose of study treatment until 30 days after last dose of study treatment or initiation of new cancer treatment, whichever comes first, assessed up to 20 weeks.