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

Completed · Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT01984242

Run by

Hoffmann-La Roche

People needed

305

Starts

2014-01-08

Expected to finish

2019-01-08

Last updated by the study team

2019-12-23

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• HonorHealth Research Institute - Bisgrove — Scottsdale, Arizona, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• UCLA — Los Angeles, California, United States
• University of California — San Francisco, California, United States
• Univ Colorado Health Sci Ctr — Aurora, Colorado, United States
• Rocky Mountain Cancer Ctr - Denver (Williams) — Denver, Colorado, United States
• Yale Uni School of Medicine; Section of Medical Oncology — New Haven, Connecticut, United States
• Georgetown U; Lombardi Comp Can — Washington D.C., District of Columbia, United States
• SCRI Florida Cancer Specialists South — Fort Myers, Florida, United States
• Mayo Clinic-Jacksonville — Jacksonville, Florida, United States
• Florida Cancer Specialist, North Region — St. Petersburg, Florida, United States
• The University of Chicago — Chicago, Illinois, 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
• Karmanos Cancer Institute. — Detroit, Michigan, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Memorial Sloan-Kettering — New York, New York, United States
• Oncology Hematology Care Inc — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation; Taussig Cancer Center — Cleveland, Ohio, United States
• Oncology Associates of Oregon, P.C — Eugene, Oregon, United States
• Northwest Cancer Specialists, P.C. — Tigard, Oregon, United States
• Tennessee Oncology PLLC - Nashville (20th Ave) — Nashville, Tennessee, United States
• Vanderbilt Medical Center — Nashville, Tennessee, United States
• Texas Oncology-Baylor Sammons Cancer Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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