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ACTIVE NOT RECRUITING
NCT04034927
PHASE2

Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II trial studies how well olaparib with or without tremelimumab works in treating patients with ovarian, fallopian tube, or peritoneal cancer that has come back (recurrent). PARPs are proteins that help repair deoxyribonucleic acid (DNA) mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Immunotherapy with monoclonal antibodies, such as tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving olaparib and tremelimumab together may work better than olaparib alone in treating patients with ovarian, fallopian tube, or peritoneal cancer.

Official title: A Phase II Randomized Trial of Olaparib Versus Olaparib Plus Tremelimumab in Platinum-Sensitive Recurrent Ovarian Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

61

Start Date

2019-12-04

Completion Date

2027-02-21

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Olaparib

Given PO

BIOLOGICAL

Tremelimumab

Given IV

Locations (20)

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Augusta University Medical Center

Augusta, Georgia, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States

Case Western Reserve University

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Women and Infants Hospital

Providence, Rhode Island, United States

M D Anderson Cancer Center

Houston, Texas, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States