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) |
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.
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
sites
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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1515 Holcombe Blvd
Houston, Texas 77030
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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Women's Cancer Center of Nevada The Women's Cancer Center is a recognized leader in the...
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University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 805-3666
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Florida Hospital Florida Hospital is one of the country
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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