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



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/27/2019
Start Date:May 20, 2015
End Date:December 1, 2021

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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

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.


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

- 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

- Baseline electrocardiogram showing corrected QT interval greater than 460 milliseconds
We found this trial at
34
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Atlanta, Georgia 30318
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Boca Raton, FL
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Boston, Massachusetts 02115
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143 Missenden Road
Camperdown, New South Wales 2050
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Chattanooga, Tennessee 37404
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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1800 North Williams Street
Denver, Colorado 80218
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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3730 South Eastern Avenue
Las Vegas, Nevada 89169
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Louisville, Kentucky 40207
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Macon, Georgia 31201
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340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
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250 25th Avenue North
Nashville, Tennessee 37203
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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101 The City Drive South
Orange, California 92868
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Pittsburgh, Pennsylvania 15212
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22395 Edgewater Drive
Port Charlotte, Florida 33980
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2013 Jefferson Street Southwest
Roanoke, Virginia 24014
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1201 5th Avenue North
Saint Petersburg, Florida 33705
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San Francisco, California 94143
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19260 Southwest 65th Avenue
Tualatin, Oregon 97062
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Tucson, Arizona 85724
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3970 Reservoir Road Northwest
Washington, District of Columbia 20016
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West Palm Beach, Florida 33401
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