Eine Studie zu Atezolizumab in Kombination mit Bevacizumab gegenüber Sunitinib bei Teilnehmenden mit unbehandeltem fortgeschrittenem Nierenzellkarzinom (RCC)

• 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

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