Enrollment complete
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)
NCT No.: NCT03522246
Study Type: INTERVENTIONAL
Phase:
Phase III
Region: California - Northern
Acronym: ATHENA
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)
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.
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.
Age Limit
18 years & older
Eligibility Criteria
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;
|
Keywords and/or Specific Medical Conditions
|
|
|
|
|
|
|
|
-
Endocrine Gland Neoplasms
|
-
Endocrine System Diseases
|
|
|
|
|
|
-
Genital Neoplasms, Female
|
|
|
|
|
|
|
|
-
Molecular Mechanisms of Pharmacological Action
|
|
-
Neoplasms by Histologic Type
|
|
-
Neoplasms, Glandular and Epithelial
|
|
|
|
|
|
|
|
-
Physiological Effects of Drugs
|
-
Poly(ADP-ribose) Polymerase Inhibitors
|
|
|
|
|
|
|
|
Sponsors
|
- Gynecologic Oncology Group
|
|