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
Principal Investigator
Ying Liu, MD,
Status
Open to Accrual
Date Opened To Accrual
January 16 2025
Disease Site
Gynecologic [GY]
Ovarian
Phase
III
Developmental Therapeutics
No
Primary Objective
To determine investigator assessed progression-free survival using RECIST v1.1 (non-inferiority) for one vs. two years of maintenance olaparib.This analysis is supported by a modified ITT population limited to patients on protocol at least 360 days after randomization. The time at risk for this population starts 360 days after randomization (Section 15.3).This analysis is denoted PFS360.
Patient Population
Patients with BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy.
Target Accrual
880
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.