NRG-GY036

Clinical Trial Title A Phase III Trial of One vs. Two Years of Maintenance Olaparib, with or without Bevacizumab, in Patients with BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy
Trial Status Open to Enrollment
Start Date 02/28/2025
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Ovarian Cancer
Description This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.
Eligibility Criteria

Eligibility Criteria

  • Patients with newly diagnosed, pathologically confirmed, FIGO Stage III or IV ovarian cancer of the following types:
  •     high grade serous,
  •     high grade endometrioid, and/or
  •     other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic).
  • Patients must have:
  • 1) Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration).
  • OR
  • 2) BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, CLIA-certified laboratory (e.g., Myriad MyChoice©)
  • Patient must have undergone cytoreductive surgery (primary or interval).
  • Patients must have completed first line platinum-based therapy prior to registration
  • Patients must be randomized at least 3 weeks and no more than 12 weeks after their last dose of chemotherapy (last dose is the day of the last infusion of platinum agent).

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

 
IRB Number Central IRB
Notes Study Details | Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer | ClinicalTrials.gov
Principal Investigator Julia Fehniger, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org