ATHENA (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment following Response to Front-Line Platinum-Based Chemotherapy)
Please read this consent form carefully. It may contain words that are not familiar to you. Please ask the study doctor or study staff to explain any words or information that you do not understand. You may take home a copy of this consent form to review or discuss with family or friends before making your decision. You are being asked to take part in this study because you have newly diagnosed, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer that has responded to chemotherapy. This consent form tells you why this research study is being done and what tests are involved. It also describes responsibilities that you will have if you join this study. It explains any possible benefits and possible risks of taking part in this study. It also explains how your medical information will be used and who may see it. The goal of this clinical research study is to learn if the combination of rucaparib and nivolumab can help to control ovarian cancer. The safety of this drug combination will also be studied. Researchers will also be performing biomarker testing and pharmacokinetic (PK) testing throughout the study. Biomarkers are substances such as genetic material (DNA) and proteins found in blood and tumor tissue that might show if a cancer patient will respond or not respond to a treatment. PK testing measures the amount of study drug in the body at different time points. In this study, a placebo will be used. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Disease Group: Malignant neoplasms of female genital organs
Treatment Agent: Nivolumab, Rucaparib
Treatment Location: Both at MD Anderson & Other Sites
Sponsor: Clovis Oncology, Inc.
IRB Review and Approval Date: 12/04/2018
Recruitment Status: Open
Projected Accrual: 1012
Information and next steps
Malignant neoplasms of female genital organs
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