A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) as Monotherapy or in Combination With Bevacizumab (Avastin®) Compared to Sunitinib (Sutent®) in Participants With Untreated Advanced Renal Cell Carcinoma



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/28/2019
Start Date:January 31, 2014
End Date:January 8, 2019

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A Phase II, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Administered as Monotherapy or in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma

This multicenter, randomized, open-label study will evaluate the efficacy, safety and
tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus
sunitinib in participants with histologically confirmed, inoperable, locally advanced or
metastatic renal cell carcinoma who have not received prior systemic therapy either in the
adjuvant or metastatic setting.


Inclusion Criteria:

- Unresectable advanced or metastatic renal cell carcinoma with component of clear cell
histology and/or component of sarcomatoid histology that has not been previously
treated with any systemic agents, including treatment in the adjuvant setting

- Measurable disease, as defined by RECIST v1.1

- Karnofsky performance score greater than or equal to (>/=) 70

- Adequate hematologic and end-organ function as defined by protocol

- Women of childbearing potential and male participants with partners of childbearing
potential must agree to use highly effective methods of contraception as defined by
protocol

Exclusion Criteria:

Disease-Specific Exclusions:

- Radiotherapy for renal cell carcinoma within 14 days prior to Cycle 1, Day 1 with the
exception of single-fraction radiotherapy given for the indication of pain control

- Known active malignancies or metastasis of the brain or spinal cord or leptomeningeal
disease, as determined by computed tomography (CT) or magnetic resonance imaging (MRI)
evaluation during screening and prior radiographic assessments

- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures (once monthly or more frequently)

- Uncontrolled hypercalcemia or symptomatic hypercalcemia

- Malignancies other than renal cell carcinoma within 5 years prior to Cycle 1, Day 1,
with the exception of those with a negligible risk of metastasis or death, treated
with expected curative outcome

General Medical Exclusions:

- Life expectancy of less than (<) 12 weeks

- Pregnant and lactating women

- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins

- History of autoimmune disease

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest CT scan

- Participants with active or chronic hepatitis B, active hepatitis C, Human
Immunodeficiency Virus (HIV) positive test, significant cardiovascular disease

- Prior allogeneic stem cell or solid organ transplant

Exclusion Criteria Related to Medications:

- Prior treatment with Cluster of Differentiation 137 (CD137) agonists, anti-Cytotoxic
T-Lymphocyte Antigen-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), or
anti-PD-L1 therapeutic antibody or pathway-targeting agents

- Treatment with systemic immunostimulatory agents for any reason within 6 weeks or five
half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1

- Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1,
Day 1

Bevacizumab- and Sunitinib-Specific Exclusions:

- Inadequately controlled hypertension

- Prior history of hypertensive crisis or hypertensive encephalopathy

- New York Heart Association Class II or greater congestive heart failure

- History of myocardial infarction or unstable angina, stroke or transient ischemic
attack within 3 months prior to Cycle 1, Day 1
We found this trial at
26
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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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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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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Boston, Massachusetts 02115
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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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Detroit, Michigan 48201
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Eugene, Oregon 97401
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
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Jacksonville, Florida 32216
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Los Angeles, California 90095
(310) 825-4321
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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300 20th Avenue North
Nashville, Tennessee 37203
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Nashville, Tennessee 37212
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333 Cedar Street
New Haven, Connecticut 06510
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New York, New York 10065
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1201 5th Avenue North
Saint Petersburg, Florida 33705
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San Francisco, California 94143
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Scottsdale, Arizona 85258
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Tualatin, Oregon 97062
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3970 Reservoir Road Northwest
Washington, District of Columbia 20016
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