A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy



Status:Recruiting
Conditions:Ovarian Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:May 14, 2018
End Date:December 30, 2030
Contact:Clovis Oncology Clinical Trial Information
Email:clovistrials@emergingmed.com
Phone:1-855-262-3040 (USA)

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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)

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.


Inclusion Criteria:

- Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or
primary peritoneal cancer.

- Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy
and partial omentectomy, either prior to chemotherapy (primary surgery) or following
neoadjuvant chemotherapy (interval debulking)

- Completed first-line platinum-based chemotherapy and surgery with a response, in the
opinion of the Investigator

- Sufficient tumor tissue for planned analysis

- ECOG performance status of 0 or 1

Exclusion Criteria:

- Pure sarcomas or borderline tumors or mucinous tumors

- Active second malignancy

- Known central nervous system brain metastases

- Any prior treatment for ovarian cancer, other than the first-line platinum regimen

- Evidence of interstitial lung disease or active pneumonitis

- Active, known or suspected autoimmune disease

- Condition requiring active systemic treatment with either corticosteroids (>10 mg
daily prednisone equivalent) or other immunosuppressive medications
We found this trial at
63
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750 East Adams Street
Syracuse, New York 13210
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Fort Myers, Florida 33901
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Albany, New York 12208
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Augusta, Georgia 30912
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Aurora, Colorado 80045
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Austin, Texas 78731
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Bedford, Texas 76022
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Concord, California 94520
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Detroit, Michigan 48201
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Durham, North Carolina 27710
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Florham Park, New Jersey 07932
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Fort Worth, Texas 76104
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Houston, Texas 77030
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Indianapolis, Indiana 46256
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Iowa City, Iowa 52242
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Jacksonville, Florida 32207
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Johnson City, New York 13790
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Lake Success, New York
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Lakewood, Colorado 80228
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3131 La Canada St # 241
Las Vegas, Nevada 89169
(702) 693-6870
Women's Cancer Center of Nevada The Women's Cancer Center is a recognized leader in the...
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Louisville, Kentucky 40207
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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New York, New York 10021
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Oklahoma City, Oklahoma 73104
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Phoenix, Arizona 85016
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Pittsburgh, Pennsylvania 15213
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Portland, Oregon 97213
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Portland, Oregon 97210
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Saint Louis Park, Minnesota 55416
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Salt Lake City, Utah 84112
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San Francisco, California 94115
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Scarborough, Maine 04074
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Sioux Falls, South Dakota 57105
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Springfield, Illinois 65807
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Springfield, Missouri 65804
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Tucson, Arizona 85724
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Westwood, Kansas 66205
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Willow Grove, Pennsylvania 19090
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