Skip Navigation Links
A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
Overall Recruitment Status: Active, enrollment completed
 
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)
 
Region Sponsors
California - Northern
Clovis Oncology, Inc.
Gynecologic Oncology Group
 
Acronym KP IRB No.
ATHENA 1325938
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Adults with newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
 
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.
 
Gender Age Limit
Male & Female
 
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
  • Molecular Mechanisms of Pharmacological Action
  • Antibodies, Monoclonal
  • Neoplasms
  • Antineoplastic Agents
  • Neoplasms by Histologic Type
  • ATHENA
  • Neoplasms by Site
  • BRCA
  • Neoplasms, Glandular and Epithelial
  • DNA anomaly
  • Nivolumab
  • DNA defect
  • Nivolumab
  • DNA repair
  • Ovarian Diseases
  • Endocrine Gland Neoplasms
  • Ovarian Neoplasms
  • Endocrine System Diseases
  • PARP inhibitor
  • Enzyme Inhibitors
  • PARPi
  • Fallopian Tube Diseases
  • PD-1
  • Fallopian Tube Neoplasms
  • Physiological Effects of Drugs
  • First-line
  • Poly(ADP-ribose) Polymerase Inhibitors
  • Genital Diseases, Female
  • Primary Therapy
  • Genital Neoplasms, Female
  • Primary Treatment
  • Gonadal Disorders
  • Rucaparib
  • homologous recombination
  • Rucaparib
  • HRD
  • Tumor mutational burden
  • Immuno Oncology
  • Urogenital Neoplasms
  • Immunologic Factors
  • Oncology (Adult)
  • LOH
 
KP Clinical Facility
  • Diablo Medical Center-Walnut Creek
  • Hayward Medical Center
  • Oakland Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Teresa Medical Center-San Jose
  • South San Francisco Medical Center
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Ramey Littell, MD
Contact Information:
- Desiree Goldstein
-Desiree.Goldstein@kp.org
-Vallejo Medical Center


smilelady1
Do you want to receive
Email Alerts?

Sign Up Here!





Regional Research Sites: