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A Study of ATEZOLIZUMAB (Anti-PD-L1 Antibody) in combination with Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma

A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB (Anti-PD-L1 ANTIBODY) IN COMBINATION WITH BEVACIZUMAB VERSUS SUNITINIB IN PATIENTS WITH UNTREATED ADVANCED RENAL CELL CARCINOMA

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222931
Enrollment
915
Registered
2015-08-05
Start date
2015-10-21
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

Renal Cell Carcinoma

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
All

Inclusion criteria

Inclusion criteria: - Adults greater than or equal to (>/=) 18 years of age - Unresectable advanced or metastatic RCC with clear cell histology and/or component of sarcomatoid carcinoma - Evaluable Memorial Sloan Kettering Cancer Center (MSKCC) risk score - Measurable disease as defined by RECIST v1.1 - Karnofsky performance status (KPS) >/=70% - Adequate hematologic and end-organ function

Exclusion criteria

Exclusion criteria: - Radiotherapy for RCC within 14 days prior to treatment - Central nervous system (CNS) disease - Uncontrolled pleural effusion, pericardial effusion, or ascites - Uncontrolled hypercalcemia - Any other malignancies within 5 years except for low-risk prostate cancer or those with negligible risk of metastasis or death - Life expectancy less than () 460 milliseconds (ms)

Design outcomes

Primary

MeasureTime frame
efficacy confirmatory RECIST version 1.1, etc.

Secondary

MeasureTime frame
safety efficacy exploratory pharmacokinetics RECIST version 1.1, modified RECIST critera, etc.

Countries

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

Outcome results

None listed

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