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

pharmaand

Status and phase: Active, not recruiting; Phase 3

Conditions: FIGO Stage III-IV; Newly Diagnosed; Epithelial Ovarian Cancer; Partial Response; Primary Peritoneal; Complete Response; Fallopian Tube Cancer

Treatments: Drug: Placebo Oral Tablet; Drug: Rucaparib; Drug: Placebo IV Infusion; Drug: Nivolumab

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT03522246

2017-004557-17 (EudraCT Number)

CO-338-087/GOG-3020/ENGOT-ov45

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,000 participants in 4 patient groups, including a placebo group

Arm A

Experimental group

Description:

oral rucaparib + intravenous (IV) nivolumab

Treatment:

Drug: Nivolumab

Drug: Rucaparib

Arm B

Experimental group

Description:

oral rucaparib+IV placebo

Treatment:

Drug: Placebo IV Infusion

Drug: Rucaparib

Arm C

Experimental group

Description:

oral placebo+ IV nivolumab

Treatment:

Drug: Nivolumab

Drug: Placebo Oral Tablet

Arm D

Placebo Comparator group

Description:

Oral placebo + IV placebo

Treatment:

Drug: Placebo IV Infusion

Drug: Placebo Oral Tablet