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Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer

NCT02915523 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-01-10

Study results available
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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 participants with refractory or recurrent epithelial ovarian cancer.

Conditions

Interventions

DRUG

entinostat

An orally available histone deacetylases inhibitor (HDACi).

DRUG

avelumab

A fully human antibody of the immunoglobulin (Ig) G1 isotype that targets and blocks Programmed death-ligand 1 (PD-L1), the ligand for Programmed cell death protein 1 (PD-1) receptor.

DRUG

Placebo

A pill containing no active drug ingredient.

Sponsors & Collaborators

Principal Investigators

  • Michael Meyers, MD, PhD · Syndax Pharmaceuticals

  • Ursula Matulonis, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-19
Primary Completion
2019-02-21
Completion
2021-04-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02915523 on ClinicalTrials.gov