A STUDY OF ATEZOLIZUMAB VERSUS PLACEBO ADMINISTERED IN COMBINATION WITH PACLITAXEL, CARBOPLATIN, AND BEVACIZUMAB TO PATIENTS WITH NEWLY DIAGNOSED STAGE III OR STAGE IV OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER [IMaGYN050]

Phase 3

Completed

• Conditions: OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER

• Registration Number: JPRN-jRCT2080223474
• Lead Sponsor: CHUGAI PHARMACEUTICAL CO., LTD.

Brief Summary

Atezolizumab did not show statistically significant prolongation of PFS and OS in ITT and PD-L1+ population. Adverse events were consistent with the known safety profiles of each agent.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-08
• Results First Posted: 2021-04-23
• Study Completion: 2023-02-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: Female
• Target Recruitment: 1301

Inclusion Criteria

Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC),peritoneal primary carcinoma, or fallopian tube cancer
-Eastern Cooperative Oncology Group (ECOG) performance status of 0,1,or 2
-Life expectancy greater than (>) 12 weeks
-Adequate hematologic and end organ function
-For participants who receive therapeutic anticoagulation:stable anticoagulant regimen

Exclusion Criteria

-Received a current diagnosis of tumors of low malignant potential (borderline epithelial ovarian cancer), or non-epithelial ovarian tumors
-Have recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer
-Other invasive malignancies with any evidence of other cancers present within the last 5 years with the exception of other specific malignancies(e.g. localized breast cancer)
-Pregnant or lactating women
-History of autoimmune disease
-Have a positive test result for HIV, active hepatitis B or hepatitis C infection
-Significant cardiovascular disease
-Prior treatment with CD137 agonists or immune checkpoint blockade therapies,anti-PD1,anti-PD-L1,or anti-CTLA4 therapeutic antibody

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Progression-Free survival, Overall survival<br><br>RECIST v1.1, Observation

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>Objective response rate, Safety, etc.<br><br>RECIST v1.1, Observation, etc.