This study is in progress, not accepting new patients

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

a study on Ovarian Cancer Primary Peritoneal Fallopian Tube Cancer Newly FIGO Stage III-IV Partial Response Complete Response

Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
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
  • 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

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
    La Jolla California 92037-0845 United States
  • Women's Cancer Center of Nevada
    Las Vegas Nevada 89169 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Clovis Oncology, Inc.
ID
NCT03522246
Phase
Phase 3
Study Type
Interventional
Last Updated