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

Inclusion Criteria

• Histologically-confirmed disease
• Phase 1: Individuals with epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinomas who are considered to have platinum-resistant disease (progression within 6 months from completion of platinum-based chemotherapy).
• Phase 2: Individuals with epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinomas who are considered to have platinum-resistant disease (progression within 6 months from completion of a minimum of 4 platinum therapy cycles).
• Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Agree to provide core biopsies at baseline and at Cycle 2 Day 15
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Available archived tumor tissue for central analysis
• Adequate organ and marrow function

Exclusion Criteria

• Platinum-refractory disease (progression during the first platinum-based chemotherapy)
• Major surgical procedure within 4 weeks prior to Study Day 1
• Inaccessible tumors or for whom biopsy is contraindicated
• Clinically significant ascites
• Phase 2 only: Previous treatment with >3 chemotherapy regimens for locally advanced or metastatic disease
• Active bowel obstruction, or hospitalization for bowel obstruction within 2 months prior to screening
• Require parenteral nutrition
• Hospitalization within 2 weeks prior to screening
• Received any anticancer medication or therapy in the 21 days prior to study Day 1
• Prior monoclonal antibody treatment within 4 weeks before study Day 1
• History of listeriosis or previous treatment with a listeria-based immunotherapy
• Known allergy to both penicillin and sulfa antibiotics
• Any immunodeficiency disease or immune-compromised state
• Received prior immune checkpoint inhibitors (e.g., anti-CTLA-4, anti-PD-1, anti PDL-1) and any other antibody or drug specifically targeting T-cell costimulation or an IDO inhibitor
• Pregnant or breastfeeding
• Clinically significant heart disease
• Valvular heart disease that requires antibiotic prophylaxis for prevention of endocarditis
• History of any autoimmune disease which required systemic therapy in the past 2 years
• Diagnosed with another malignancy within the past 3 years
• Currently receiving therapy with a UDP-glucuronosyltransferase 1A9 inhibitor including diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid
• Receiving monoamine oxidase inhibitor (MAOIs) or a drug which has significant MAOI activity (meperidine, linezolid, methylene blue) within the 21 days before screening
• Had prior serotonin syndrome
• Has implanted medical devices that pose high risks for colonization and cannot be easily removed