Phase 1b/2 Study of Avelumab With or Without Entinostat in Patients With Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
About this trial
This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Ovarian Cancer, Histone Deacetylase Inhibitors, Entinostat, Solid tumor, Avelumab, SNDX-275, Ovarian Neoplasms, Ovarian Diseases, Fallopian Tube Cancer, Peritoneal Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer
- Recurrent or progressive disease on or after initial platinum-based chemotherapy
- Evidence of measurable disease based on imaging studies within 28 days before the first dose of study drug
- Previously received at least 3, but no more than 6, lines of therapy including at least 1 course of platinum-based therapy
- Patient must have acceptable, applicable laboratory requirements
- Patients may have a history of brain metastasis provided certain protocol criteria are met
- Experienced resolution of toxic effect(s) of the most recent prior anti-cancer therapy to Grade ≤1 (except alopecia or neuropathy)
- Able to understand and give written informed consent and comply with study procedures.
Exclusion Criteria:
- Non-epithelial ovarian carcinomas or ovarian tumors with low malignant potential (i.e., borderline tumors)
- Another known malignancy that is progressing or requires active treatment (excluding adequately treated basal cell carcinoma or cervical intraepithelial neoplasia/cervical carcinoma in situ or melanoma in situ). Prior history of other cancer is allowed, as long as there is no active disease within the prior 5 years.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment.
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- Previously treated with a histone deacetylase inhibitor (i.e., vorinostat, belinostat, romidepsin, panobinostat), PD-1/PD-L1-blocking antibody (i.e., atezolizumab, nivolumab, pembrolizumab), or a cytotoxic T-lymphocyte associated protein-4 (CTLA-4) agent
- Currently enrolled in (or completed) another investigational drug study within 30 days prior to study drug administration
- A medical condition that precludes adequate study treatment or increases patient risk
Sites / Locations
- H. Lee Moffitt Cancer Center and Research
- Florida Cancer Specialist East Region (SCRI Affiliate)
- University of Chicago
- Greater Baltimore Medical Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
- Massachusetts General Hospital
- Dana Farber Cancer Institute
- HCA Midwest Health (SCRI Affiliate)
- Memorial Sloan Kettering Cancer Center
- University of Pennsylvania
- Sarah Cannon Research Institute
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Entinostat plus Avelumab
Placebo plus Avelumab
Avelumab is administered intravenously (IV) on Day 1 of each 14-day cycle in combination with Entinostat administration on D1 and D8 of each cycle at the Maximum tolerated Dose (MTD)/RP2D as determined in the Phase Ib (Dose Determination) part of the study.
Avelumab is administered intravenously (IV) on Day 1 of each 14-day cycle in combination with placebo administered on D1 and D8 of each cycle.