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 |
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.
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
3730 South Eastern Avenue
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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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
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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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
Marietta, Georgia 30060
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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
Orange, California 92868
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2013 Jefferson Street Southwest
Roanoke, Virginia 24014
Roanoke, Virginia 24014
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19260 Southwest 65th Avenue
Tualatin, Oregon 97062
Tualatin, Oregon 97062
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3970 Reservoir Road Northwest
Washington, District of Columbia 20016
Washington, District of Columbia 20016
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