Summary

for females ages 18 years and up (full criteria)
at UCLA UCSD UCSF
study started
estimated completion

Description

Summary

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.

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)

Keywords

Epithelial Ovarian Cancer Primary Peritoneal Fallopian Tube Cancer Newly Diagnosed FIGO Stage III-IV Partial Response Complete Response PARP inhibitor PARPi HRD ATHENA homologous recombination DNA repair LOH DNA defect DNA anomaly Rucaparib Nivolumab PD-1 Immuno- oncology Tumor mutational burden BRCA First-line Primary Therapy Primary Treatment Ovarian Neoplasms Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSD Moores Cancer Center accepting new patients
    La Jolla California 92037-0845 United States
  • UCSF Medical Center - Investigational Drugs Pharmacy accepting new patients
    San Francisco California 94158 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Clovis Oncology, Inc.
ID
NCT03522246
Phase
Phase 3
Study Type
Interventional
Last Updated