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

Inclusion Criteria:

1. 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).

2. Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1

3. Agree to provide core biopsies at baseline and at Cycle 2 Day 15

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

5. Available archived tumor tissue for central analysis

6. Adequate organ and marrow function

Exclusion Criteria

1. Platinum-refractory disease (progression during the first platinum-based chemotherapy)

2. Major surgical procedure within 4 weeks prior to Study Day 1

3. Inaccessible tumors or for whom biopsy is contraindicated

4. Clinically significant ascites

5. Phase 2 only: Previous treatment with >3 chemotherapy regimens for locally advanced or
metastatic disease

6. Active bowel obstruction, or hospitalization for bowel obstruction within 2 months
prior to screening

7. Require parenteral nutrition

8. Hospitalization within 2 weeks prior to screening

9. Received any anticancer medication or therapy in the 21 days prior to study Day 1

10. Prior monoclonal antibody treatment within 4 weeks before study Day 1

11. History of listeriosis or previous treatment with a listeria-based immunotherapy

12. Known allergy to both penicillin and sulfa antibiotics

13. Any immunodeficiency disease or immune-compromised state

14. 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

15. Pregnant or breastfeeding

16. Clinically significant heart disease

17. Valvular heart disease that requires antibiotic prophylaxis for prevention of
endocarditis

18. History of any autoimmune disease which required systemic therapy in the past 2 years

19. Diagnosed with another malignancy within the past 3 years

20. Currently receiving therapy with a UDP-glucuronosyltransferase 1A9 inhibitor including
diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid

21. Receiving monoamine oxidase inhibitor (MAOIs) or a drug which has significant MAOI
activity (meperidine, linezolid, methylene blue) within the 21 days before screening

22. Had prior serotonin syndrome

23. Has implanted medical devices that pose high risks for colonization and cannot be
easily removed