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 Peritoneal Fallopian Tube Cancer FIGO Ovarian Epithelial Carcinoma

Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Sanaz Memarzadeh (ucla)
Headshot of Sanaz Memarzadeh
Sanaz Memarzadeh

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, Ovarian Epithelial Carcinoma, 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

  • UCLA Women's Health Clinical Research Unit
    Los Angeles California 90095 United States
  • John Muir Clinical Research Center
    Concord California 94520 United States
  • Kaiser Permanente Northern California
    San Francisco California 94589 United States

Lead Scientist at University of California Health

  • Sanaz Memarzadeh (ucla)
    At the G.O. Discovery Lab directed by Sanaz Memarzadeh, we are on a mission to help patients with gynecologic cancers. Our research is focused on two understudied and aggressive epithelial gynecologic cancers that affect thousands of women each year: ovarian and endometrial carcinomas.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
pharmaand GmbH
ID
NCT03522246
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1000 study participants
Last Updated