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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]

A PHASE III, MULTICENTER, RANDOMIZED, 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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223474
Enrollment
1300
Registered
2017-03-08
Start date
2017-06-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER

Interventions

investigational material(s) Generic name etc : Atezolizumab INN of investigational material : atezolizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investig

Sponsors

CHUGAI PHARMACEUTICAL CO., LTD.
Lead Sponsor
F. Hoffmann-La Roche Ltd.
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
efficacy Progression-Free survival, Overall survival RECIST v1.1, Observation

Secondary

MeasureTime frame
safety efficacy Objective response rate, Safety, etc. RECIST v1.1, Observation, etc.

Countries

Asia except Japan, Europe, Japan, North America, Oceania, Russian Federation, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026