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

Completed · Phase 3

Conditions studied: Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT02420821

Run by

Hoffmann-La Roche

People needed

915

Starts

2015-05-20

Expected to finish

2021-12-13

Last updated by the study team

2023-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Known hypersensitivity to any component of atezolizumab or other study medication
• History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes mellitus
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis
• Positive human immunodeficiency virus test
• Active or chronic hepatitis B or C
• Severe infections within 4 weeks prior to treatment
• Exposure to oral or IV antibiotics within 2 weeks prior to treatment
• Live attenuated vaccines within 4 weeks prior to treatment (for influenza vaccination participants must agree not to receive live, attenuated influenza vaccine within 4 weeks prior to treatment, during treatment or within 5 months following the last dose)
• Significant cardiovascular disease
• Prior allogeneic stem cell or solid organ transplantation
• Exclusion Criteria Related to Medications:
• Prior treatment with cluster of differentiation 137 agonists, anti-cytotoxic T-lymphocyte associated protein-4, anti-programmed death (PD)-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
• Treatment with immunostimulatory agents for non-malignant conditions within 6 weeks or immunosuppressive agents within 2 weeks prior to treatment
• Bevacizumab- and Sunitinib-Specific Exclusions:
• History of hypertensive crisis or hypertensive encephalopathy

Where it is running

• 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
• The University of Chicago — Chicago, Illinois, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Inst. — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Comprehensive Cancer Centers of Nevada - Eastern Avenue — Las Vegas, Nevada, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• New York Oncology Hematology,P.C.-Albany — Albany, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Oncology Hematology Care Inc — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation; Taussig Cancer Center — Cleveland, Ohio, United States
• Northwest Cancer Specialists, P.C. — Tigard, Oregon, United States
• SCRI Tennessee Oncology Chattanooga — Chattanooga, Tennessee, United States
• Sarah Cannon Cancer Center and Research Institute — Nashville, Tennessee, United States
• Vanderbilt Univ Medical Ctr — Nashville, Tennessee, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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