A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab (IND #134427) Versus Pegylated Liposomal Doxorubicin, CTEP-Supplied Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin and CTEP-Supplied Bevacizumab in Platinum Resistant Ovarian Cancer
Principal Investigator
Roisin O'Cearbhaill, MD
Status
Closed to Accrual
Date Opened To Accrual
April 17 2017
Date Closed to Accrual
October 14 2021
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
444
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.