The trial is taking place at:
C

Cooper University HealthCare | MD Anderson Cancer Center at Cooper

Veeva-enabled site

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

P

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: Rucaparib
Drug: Placebo Oral Tablet
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

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

Trial contacts and locations

238

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Data sourced from clinicaltrials.gov

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