NRG-GY036

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

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