Ovarian Cancer Clinical Trial
Safety and Efficacy of CRS-207 With Epacadostat in Platinum Resistant Ovarian, Fallopian or 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:
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
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There are 12 Locations for this study
Scottsdale Arizona, 85258, United States
Stanford California, 94305, United States
Gainesville Florida, 32610, United States
Chicago Illinois, 60611, United States
Baltimore Maryland, 21287, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19111, United States
Charlottesville Virginia, 22903, United States
Seattle Washington, 98101, United States
Toronto Ontario, M5G 2, Canada
Montréal Quebec, H2X 0, Canada
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