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)

NOT ENROLLING
Protocol # :
18-481
Conditions
Epithelial Ovarian Cancer
Primary Peritoneal
Fallopian Tube Cancer
Newly Diagnosed
FIGO Stage III-IV
Partial Response
Complete Response
Phase
III
Disease Sites
Corpus Uteri
Ovary
Other Female Genital
Principal Investigator
Yeku, Oladapo, O
Site Investigator
Campos, Susana, Maria
Cannistra, Stephen, A.
Shea, Meghan
Site Research Nurses
Bowers, Mary, Ellen

Trial Description

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.

Eligibility Requirements

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

- Patients must be 20 years of age to consent in Japan, Taiwan and South Korea; in all
other participating countries patients must be 18 years of age to consent

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

18-481