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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.

Sex

Female

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

  • Adnexal Diseases
  • Antibodies, Monoclonal
  • Antineoplastic Agents
  • ATHENA
  • BRCA
  • DNA anomaly
  • DNA defect
  • DNA repair
  • Endocrine Gland Neoplasms
  • Endocrine System Diseases
  • Enzyme Inhibitors
  • Fallopian Tube Diseases
  • Fallopian Tube Neoplasms
  • First-line
  • Genital Diseases, Female
  • Genital Neoplasms, Female
  • GOG-3020
  • Gonadal Disorders
  • homologous recombination
  • HRD
  • Immuno Oncology
  • Immunologic Factors
  • LOH
  • Molecular Mechanisms of Pharmacological Action
  • Neoplasms
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Neoplasms, Glandular and Epithelial
  • Nivolumab
  • Nivolumab
  • Ovarian Diseases
  • Ovarian Neoplasms
  • PARP inhibitor
  • PARPi
  • PD-1
  • Physiological Effects of Drugs
  • Poly(ADP-ribose) Polymerase Inhibitors
  • Primary Therapy
  • Primary Treatment
  • Rucaparib
  • Rucaparib
  • Tumor mutational burden
  • Urogenital Neoplasms
  • Oncology (Adult)

Sponsors

  • Clovis Oncology, Inc.
  • Gynecologic Oncology Group

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