NRG-GY036

Open to Accrual

Return to Protocol Table

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

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

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.

Other

NRG-GY036 Study Overview by Dr. Ying Liu

Patient Study Webpage

There is no available patient study webpage available for this trial at this time.

Support NRG Oncology.
Help Our Cause.

We are a leading protocol organizations within the National Clinical Trials Network and we seek to improve the lives of cancer patients by conducting practice-changing, multi-institutional clinical and translational research. Learn More

Donate Today

NRG Oncology Foundation, Inc, is a nonprofit, tax-exempt foundation. Donations to NRG Oncology help us conduct this important mission, and are tax-deductible to the extent permitted by law.