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| Overall Recruitment Status: Active, enrollment completed |
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| 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) |
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| Region |
Sponsors |
| California - Northern |
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| Acronym |
KP IRB No. |
| ATHENA |
1325938 |
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| Study Type |
Phase |
| Clinical Trial |
Phase III |
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| Study Population Description |
| Adults with newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. |
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| Purpose |
| 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. |
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| Detailed Description |
| This is a randomized, multinational, double-blind, dual placebo-controlled, 4-arm study, Phase 3 study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment (surgery and platinum-based chemotherapy) in newly diagnosed ovarian cancer patients. This study will enroll patients with high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer who achieved a response to their first platinum-based regimen. |
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| Gender |
Age Limit |
| Male & Female |
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- Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer
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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)
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Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator
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Sufficient tumor tissue for planned analysis
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ECOG performance status of 0 or 1
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- Pure sarcomas or borderline tumors or mucinous tumors
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Known central nervous system brain metastases
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Any prior treatment for ovarian cancer, other than the first-line platinum regimen
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Evidence of interstitial lung disease or active pneumonitis
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Active, known or suspected autoimmune disease
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Condition requiring active systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications
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Molecular Mechanisms of Pharmacological Action
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Neoplasms by Histologic Type
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Neoplasms, Glandular and Epithelial
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Endocrine Gland Neoplasms
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Endocrine System Diseases
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Physiological Effects of Drugs
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Poly(ADP-ribose) Polymerase Inhibitors
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Genital Neoplasms, Female
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