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NRG-GY009

NRG-GY009

A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab (IND #134427) versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer

 

This study is currently ONLY OPEN TO SAFETY-LEAD IN Participating Institutions

Principal Investigator/Co-Principal Investigator

Alexandra Snyder Charen, M.D./Carol Aghajanian, M.D.

Primary Objective

Safety Lead-in:  Estimate the probability of a dose limiting toxicity (DLT) following cycle 1 of experimental regimens (PLD and atezolizumab and PLD/bevacizumab and atezolizumab). 

Phase II Study: Estimate and compare the hazard of first progression or death (PFS) of each experimental regimen relative to the reference regimen, PLD and bevacizumab.

Phase III Study: Estimate and compare the hazard of death and the hazard of first progression or death (PFS) of each experimental regimen relative to the reference regimen.  If the relative hazards of death (or the hazards of first progression or death) are significantly lower on both experimental regimens, then the hazards of death (the hazards of first progression or death) on the two experimental regimens will be compared to each other.

Patient Population

Patients with high grade ovarian, fallopian tube or primary peritoneal cancer (including high grade serous; clear cell; endometrioid, grade 3; and others--adenocarcinoma, NOS; mixed epithelial carcinoma; undifferentiated carcinoma;  Recurrent, platinum resistant ovarian cancer (defined as progression within < 6 months from completion of platinum based therapy; 1-2 prior regimens (including primary therapy); Measurable disease or evaluable disease.

Target Accrual

Safety Lead-in, Stage 1: 8; Safety Lead-in, Stage 2: 8; Phase 2: 80; Phase III: 72

Status

Activated May 12, 2017

Protocol Documents

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

 

CTEP Approval Letter (pdf)

Copyright 2017 by NRG Oncology