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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

Primary Objectives 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. Secondary Objectives Phase II Study: Secondary efficacy endpoint: Estimate and compare the probabilities of response rate (ORR, either partial or complete response) defined by RECIST v1.1 criteria on each study regimen. Safety endpoint: Estimate the frequency and severity of adverse events as classified and graded with Common Terminology Criteria for Adverse Events (CTCAE) v.4.0 in those patients who initiate their randomly assigned study treatment. Phase III Study: Secondary efficacy endpoints: Estimate and compare ORR in each treatment group. Safety endpoints: Estimate the frequency and severity of adverse events in those patients who initiate their randomly assigned study treatment. Patient Reported outcomes (PRO): Estimate and compare mean patient reported outcome scores (PROs) as measured by NFOSI-18 Disease-related symptoms (DRS). Exploratory endpoints: Estimate and compare the treatment groups on the basis of the PROs: Treatment Side Effects (TSE), Function/well-being (FWB), Fatigue (FACIT-Fatigue subscale-) and Abdominal Discomfort (FACT/GOG-AD subscale). Translational Science Objectives To determine whether biomarker levels in pre-treatment tissue, and pre- or on-treatment peripheral blood, and stool specimens are associated with ORR, PFS and/or OS. Integrated Biomarker

Phase

II

Recruitment Status

Past Studies