Ovarian Cancer Clinical Trial
Phase 1b/2 Study of Avelumab With or Without Entinostat in Patients With Advanced Epithelial Ovarian Cancer
The purpose of this study is to determine the biologically active dose of entinostat, when given in combination with avelumab, that is safe and warrants further investigation. Additionally, this study will evaluate the effectiveness of entinostat in combination with avelumab at the determined dose in terms of progression free survival compared to avelumab plus placebo in patients with refractory or recurrent epithelial ovarian cancer.
The study is comprised of 2 phases: an open-label Safety Lead-in (Phase 1b) followed by an Expansion Phase (Phase 2). The Expansion Phase will evaluate the efficacy and safety of entinostat with avelumab when administered at the Recommended Phase 2 Dose (RP2D) versus avelumab alone in patients with advanced epithelial ovarian cancer in a randomized, double-blind, placebo-controlled setting. In Phase 2, patients will be randomized in a 2:1 ratio to receive avelumab plus entinostat or avelumab plus placebo, respectively.
All patients will be assessed at Screening and at specified times during the conduct of the study using standard clinical and laboratory assessments. Patients will be assessed for response through radiological assessments. Patients will continue receiving their appropriate cycles of study treatment until tumor progression or adverse events (AEs) occur which necessitate discontinuing therapy as determined by the Investigator.
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.
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
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There are 12 Locations for this study
Tampa Florida, 33612, United States
West Palm Beach Florida, 33401, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21204, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Kansas City Missouri, 64131, United States
New York New York, 10065, United States
Philadelphia Pennsylvania, 19107, United States
Nashville Tennessee, 37204, United States
Charlottesville Virginia, 22908, United States
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