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 |
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.
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
sites
9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
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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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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City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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333 Cedar Street
New Haven, Connecticut 06510
New Haven, Connecticut 06510
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3970 Reservoir Road Northwest
Washington, District of Columbia 20016
Washington, District of Columbia 20016
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