Ovarian Cancer Clinical Trial

Phase 1b/2 Study of Avelumab With or Without Entinostat in Patients With Advanced Epithelial Ovarian Cancer

Summary

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.

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Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT02915523

Recruitment Status:

Completed

Sponsor:

Syndax Pharmaceuticals

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There are 12 Locations for this study

See Locations Near You

H. Lee Moffitt Cancer Center and Research
Tampa Florida, 33612, United States
Florida Cancer Specialist East Region (SCRI Affiliate)
West Palm Beach Florida, 33401, United States
University of Chicago
Chicago Illinois, 60637, United States
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore Maryland, 21287, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
HCA Midwest Health (SCRI Affiliate)
Kansas City Missouri, 64131, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19107, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37204, United States
University of Virginia
Charlottesville Virginia, 22908, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT02915523

Recruitment Status:

Completed

Sponsor:


Syndax Pharmaceuticals

How clear is this clinincal trial information?

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