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A PHASE III, MULTICENTER, RANDOMIZED, PLACEBO CONTROLLED STUDY OF ATEZOLIZUMAB VERSUS PLACEBO IN COMBINATION WITH PACLITAXEL, CARBOPLATIN, AND BEVACIZUMAB FOR PATIENTS WITH NEWLY DIAGNOSED STAGE III/IV OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER
Primary Objective
To evaluate the efficacy of atezolizumab versus placebo in combination with paclitaxel plus carboplatin plus bevacizumab among all patients and in those patients with PD-L1positive tumors
Secondary Objectives
Among patients with measurable residual disease in the primary surgery group:
To evaluate the efficacy of atezolizumab versus placebo in combination with paclitaxel plus carboplatin plus bevacizumab
To evaluate the duration of efficacy observed with atezolizumab versus placebo in combination with paclitaxel plus carboplatin plus bevacizumab
Among the patients in the neoadjuvant group:
To determine the impact of atezolizumab versus placebo in combination with paclitaxel plus carboplatin plus bevacizumab on patient-reported abdominal symptoms of OC, as measured by two items from the abdominal/GI symptom scale of the EORTC QLQ-OV28
To evaluate PROs of HRQoL associated with atezolizumab versus placebo in combination with
paclitaxel plus carboplatin plus bevacizumab, as measured by the functional and HRQoL scales of the EORTC QLQ-C30
Safety Objective
To evaluate the safety and tolerability of atezolizumab versus placebo in combination with
paclitaxel plus carboplatin plus bevacizumab
Pharmacokinetic Objective
To characterize the pharmacokinetics of atezolizumab when administered in combination with
paclitaxel plus carboplatin plus bevacizumab
Exploratory Objectives
Among neoadjuvant patients only: To evaluate PCR status and its association with clinical outcomes after administration of atezolizumab versus placebo in combination with paclitaxel plus carboplatin plus bevacizumab
To evaluate the efficacy of atezolizumab versus placebo administered in combination with paclitaxel plus carboplatin plus bevacizumab
To evaluate PROs of disease and/or treatment-related symptoms associated with atezolizumab
versus placebo administered in combination with paclitaxel plus carboplatin plus bevacizumab,
as measured by the EORTC QLQ-C30 and QLQ-OV28
To evaluate any treatment burden patients may experience in association with the addition of atezolizumab to paclitaxel plus carboplatin plus bevacizumab compared with placebo plus paclitaxel plus carboplatin plus bevacizumab, as measured by a single item (from GP5: "I am bothered by side effects of treatment") from the physical wellbeing subscale of the FACT-G Quality of Life instrument
To evaluate and compare between treatment arms patients' health utility as measured by the EQ-5D-5L to generate utility scores for use in economic models for reimbursement
Immunogenicity Objective
To evaluate the immune response from patients who were administered atezolizumab
Exploratory Immunogenicity Objective
To evaluate the potential effects of ADAs
Exploratory Biomarker Objectives
To assess predictive, prognostic, and pharmacodynamic exploratory biomarkers in archival and/or fresh tumor tissue and blood and their association with disease status and/or patient response to study treatment
To identify biomarkers that are associated with resistance to atezolizumab administered in
combination with carboplatin and/or paclitaxel and/or bevacizumab activity, or can increase the knowledge and understanding of disease biology
Primary Objective
To evaluate the efficacy of atezolizumab versus placebo in combination with paclitaxel plus carboplatin plus bevacizumab among all patients and in those patients with PD-L1positive tumors
Secondary Objectives
Among patients with measurable residual disease in the primary surgery group:
To evaluate the efficacy of atezolizumab versus placebo in combination with paclitaxel plus carboplatin plus bevacizumab
To evaluate the duration of efficacy observed with atezolizumab versus placebo in combination with paclitaxel plus carboplatin plus bevacizumab
Among the patients in the neoadjuvant group:
To determine the impact of atezolizumab versus placebo in combination with paclitaxel plus carboplatin plus bevacizumab on patient-reported abdominal symptoms of OC, as measured by two items from the abdominal/GI symptom scale of the EORTC QLQ-OV28
To evaluate PROs of HRQoL associated with atezolizumab versus placebo in combination with
paclitaxel plus carboplatin plus bevacizumab, as measured by the functional and HRQoL scales of the EORTC QLQ-C30
Safety Objective
To evaluate the safety and tolerability of atezolizumab versus placebo in combination with
paclitaxel plus carboplatin plus bevacizumab
Pharmacokinetic Objective
To characterize the pharmacokinetics of atezolizumab when administered in combination with
paclitaxel plus carboplatin plus bevacizumab
Exploratory Objectives
Among neoadjuvant patients only: To evaluate PCR status and its association with clinical outcomes after administration of atezolizumab versus placebo in combination with paclitaxel plus carboplatin plus bevacizumab
To evaluate the efficacy of atezolizumab versus placebo administered in combination with paclitaxel plus carboplatin plus bevacizumab
To evaluate PROs of disease and/or treatment-related symptoms associated with atezolizumab
versus placebo administered in combination with paclitaxel plus carboplatin plus bevacizumab,
as measured by the EORTC QLQ-C30 and QLQ-OV28
To evaluate any treatment burden patients may experience in association with the addition of atezolizumab to paclitaxel plus carboplatin plus bevacizumab compared with placebo plus paclitaxel plus carboplatin plus bevacizumab, as measured by a single item (from GP5: "I am bothered by side effects of treatment") from the physical wellbeing subscale of the FACT-G Quality of Life instrument
To evaluate and compare between treatment arms patients' health utility as measured by the EQ-5D-5L to generate utility scores for use in economic models for reimbursement
Immunogenicity Objective
To evaluate the immune response from patients who were administered atezolizumab
Exploratory Immunogenicity Objective
To evaluate the potential effects of ADAs
Exploratory Biomarker Objectives
To assess predictive, prognostic, and pharmacodynamic exploratory biomarkers in archival and/or fresh tumor tissue and blood and their association with disease status and/or patient response to study treatment
To identify biomarkers that are associated with resistance to atezolizumab administered in
combination with carboplatin and/or paclitaxel and/or bevacizumab activity, or can increase the knowledge and understanding of disease biology
Recruitment Status
Past Studies