Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer
NCT ID: NCT02915523
Last Updated: 2024-01-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
140 participants
INTERVENTIONAL
2016-12-19
2021-04-21
Brief Summary
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Detailed Description
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All participants will be assessed at Screening and at specified times during the conduct of the study using standard clinical and laboratory assessments. Participants will be assessed for response through radiological assessments. Participants 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Entinostat plus Avelumab
Avelumab is administered intravenously (IV) on Day 1 of each 14-day cycle in combination with Entinostat administration on Day 1 and Day 8 of each cycle at the Maximum tolerated Dose (MTD)/RP2D as determined in the Phase Ib (Dose Determination) part of the study.
entinostat
An orally available histone deacetylases inhibitor (HDACi).
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.
Placebo plus Avelumab
Avelumab is administered intravenously (IV) on Day 1 of each 14-day cycle in combination with placebo administered on Day 1 and Day 8 of each cycle.
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.
Placebo
A pill containing no active drug ingredient.
Interventions
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entinostat
An orally available histone deacetylases inhibitor (HDACi).
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.
Placebo
A pill containing no active drug ingredient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Participant must have acceptable, applicable laboratory requirements
* Participants 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
* 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 participant risk
18 Years
FEMALE
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Pfizer
INDUSTRY
Syndax Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Meyers, MD, PhD
Role: STUDY_DIRECTOR
Syndax Pharmaceuticals
Ursula Matulonis, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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H. Lee Moffitt Cancer Center and Research
Tampa, Florida, United States
Florida Cancer Specialist East Region (SCRI Affiliate)
West Palm Beach, Florida, United States
University of Chicago
Chicago, Illinois, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
HCA Midwest Health (SCRI Affiliate)
Kansas City, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SNDX-275-0603
Identifier Type: -
Identifier Source: org_study_id
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