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A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)

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

NCT02420821•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Definitive diagnosis of unresectable locally advanced or metastatic RCC with clear-cell histology and/or a component of sarcomatoid carcinoma, with no prior treatment in the metastatic setting
•Evaluable Memorial Sloan Kettering Cancer Center risk score
•Measurable disease, as defined by RECIST v1.1
•Karnofsky performance status greater than or equal to 70%
•Adequate hematologic and end-organ function prior to randomization

Exclusion Criteria

•Disease-Specific Exclusions:
•Radiotherapy for RCC within 14 days prior to treatment
•Active central nervous system 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
•General Medical Exclusions:
•Life expectancy less than 12 weeks
•Participation in another experimental drug study within 4 weeks prior to treatment
•Pregnant or lactating women
+15 more criteria

Locations (154)

University of Arizona Cancer Center

Tucson, Arizona, United States

University of California at Irvine Medical Center; Department of Oncology

Orange, California, United States

University of California

San Francisco, California, United States

University of Colorado; Anschutz Cancer Pavilion

Aurora, Colorado, United States

Rocky Mountain Cancer Center; Medical Oncology

Boulder, Colorado, United States

Georgetown U; Lombardi Comp Can

Washington D.C., District of Columbia, United States

Lynn Cancer Institute/Boca Raton Regional Hospital

Boca Raton, Florida, United States

Florida Cancer Specialists - Port Charlotte

Port Charlotte, Florida, United States

Florida Cancer Specialist, North Region

St. Petersburg, Florida, United States

Piedmont Cancer Institute, PC

Atlanta, Georgia, United States

Key Dates

Start Date

May 20, 2015

Primary Completion Date

February 14, 2020

Completion Date

December 13, 2021

Last Updated

January 30, 2023

Enrollment

915

ACTUAL participants

Conditions

Renal Cell Carcinoma

Interventions

Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

DRUG

Bevacizumab

DRUG

Sunitinib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma