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A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
Sponsor: pharmaand GmbH
Summary
This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.
Official title: 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)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1097
Start Date
2018-05-14
Completion Date
2030-12-30
Last Updated
2025-06-24
Healthy Volunteers
No
Conditions
Interventions
Rucaparib
Oral rucaparib will be administered twice daily
Nivolumab
IV nivolumab will be administered once every 4 weeks
Placebo Oral Tablet
Placebo tablets will be administered twice daily
Placebo IV Infusion
IV placebo will be administered once every 4 weeks
Locations (238)
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
John Muir Clinical Research Center
Concord, California, United States
UCLA Women's Health Clinical Research Unit
Los Angeles, California, United States
Kaiser Permanente Northern California
San Francisco, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Rocky Mountain Cancer Centers
Lakewood, Colorado, United States
Yale University
New Haven, Connecticut, United States
Florida Gynecologic Oncology
Fort Myers, Florida, United States
MD Anderson Cancer Center-Baptist
Jacksonville, Florida, United States
Baptist Health Medical Group Oncology, LLC
Miami, Florida, United States
Florida Hospital
Orlando, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Dr. Sudarshan K. Sharma, Ltd - Gynecologic Oncology
Hinsdale, Illinois, United States
Ferrell-Duncan Clinic
Springfield, Illinois, United States
Community Health Network
Indianapolis, Indiana, United States
University of Iowa Hospitals
Iowa City, Iowa, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Maine Medical Center
Scarborough, Maine, United States
SKCCC at Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
MD Anderson Cancer Center at Cooper
Camden, New Jersey, United States
Summit Medical Group
Florham Park, New Jersey, United States
Women's Cancer Care Associates
Albany, New York, United States
Broome Oncology, LLC
Johnson City, New York, United States
Northwell Health Monter Cancer Center
Lake Success, New York, United States
New York University Medical Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Oncology Hematology Care, Inc
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
MD Anderson Cancer Center - Ohio Health
Columbus, Ohio, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, United States
LMG Gynecologic Oncology
Portland, Oregon, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Abington Memorial Hospital
Willow Grove, Pennsylvania, United States
Avera Gynecologic Oncology
Sioux Falls, South Dakota, United States
Texas Oncology - Austin Central
Austin, Texas, United States
Texas Oncology - Bedford
Bedford, Texas, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, United States
Texas Oncology - Fort Worth
Fort Worth, Texas, United States
Memorial Hermann
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, United States
Texas Oncology - The Woodlands, Gynecologic Oncology
The Woodlands, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Newcastle Private Hospital
New Lambton Heights, New South Wales, Australia
Northern Cancer Institute St Leonards
Saint Leonards, New South Wales, Australia
Prince of Wales Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Brian Fricker Oncology Centre, Burnside Hospital
Toorak Gardens, South Australia, Australia
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia
UZ Leven
Leuven, Belgium
Alberta Health Services - University of Calgary
Calgary, Alberta, Canada
Alberta Health Services and The University of Alberta
Edmonton, Alberta, Canada
BC Cancer - Abbotsford
Abbotsford British Columbia, British Columbia, Canada
BC Cancer - Kelowna
Kelowna, British Columbia, Canada
BC Cancer - Surrey
Surrey, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Nsha-Qeii Hsc
Halifax, Nova Scotia, Canada
Juravinski Cancer Center
Hamilton, Ontario, Canada
London Health Sciences Center
London, Ontario, Canada
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Centre Hospitalier de l'Université de Montreal
Montreal, Quebec, Canada
McGill University Health Center
Montreal, Quebec, Canada
Centre Integre Universitaire de sante et de service sociaux de l'Estri-Centre hospitalier univeritaire de Sherbrooke
Sherbrooke, Quebec, Canada
Masaryk Memorial Cancer Institute
Brno, Czechia
Department of Gynecology and Obstetrics, Oncogynecological center U hiversity Hospital Kralovske Vinohrady
Prague, Czechia
KOC KNTB a.s. Zlfn, Hvalfckovo nabrezf 600, 76001
Zlín, Czechia
Aalborg University Hospital
Aalborg, Denmark
Odense University Hospital
Odense, Denmark
Kuopio University Hospital
Kuopio, Finland
Klinik für Frauenheilkunde und Geburtshilfe
Dessau, Germany
Universitaetsklinikum Duesseldorf / Klinik fur Frauenheilkunde & Geburtshilfe
Düsseldorf, Germany
Universitatsklinikum National Centrum for Tumor Disease (NCT)
Heidelberg, Germany
Universitätslinikum Mannheim, Frauenklinik
Mannheim, Germany
Kliniken Suedostbayern AG, Klinikum Traunstein
Traunstein, Germany
Attikon General University Hospital
Chaïdári, Athens, Greece
University Hospital Attikon
Chaïdári, Athens, Greece
Alexandra Hospital
Athens, Greece