safety and efficacy of crs-207 with epacadostat in platinum resistant ovarian, fallopian or peritoneal cancer

Conditions: Platinum-resistant Ovarian Cancer; Platinum-resistant Fallopian Cancer; Platinum-resistant Peritoneal Cancer

Summary: this 2-part, phase 1/2 study will test investigational cancer drugs known as crs-207, epacadostat (ido), and pembrolizumab (pembro). the purpose of this study is to find out how safe it is to give the investigational drugs to women with platinum-resistant ovarian, fallopian tube, or peritoneal cancer and if it helps patients with these types of cancer live longer or can help shrink or slow the growth of cancer.


Eligibility criteria:
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

Keywords: ovarian cancer fallopian cancer primary peritoneal cancer