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
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody; Bevacizumab; Sunitinib
Intervention description: Atezolizumab will be administered according to the dosage schedule mentioned in the arm description.; Bevacizumab will be administered according to the dosage schedule mentioned in the arm description.; Sunitinib will be administered according to the dosage schedule mentioned in the arm description.
Intervention MeSH terms: Bevacizumab; Atezolizumab; Sunitinib; Antibodies; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 305.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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