NRG-GY009

A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer

Principal Investigator

Roisin O'Cearbhaill, MD

Status

Disease Site

Gynecologic [GY] Ovarian

Phase

II/III

Developmental Therapeutics

No

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

488