A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma

Official Title

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

Summary:

This randomized, open-label study is designed to evaluate the efficacy and safety of atezolizumab (anti-programmed death ligand 1 [PD-L1] antibody) plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.

Trial Description

Primary Outcome:

  • Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) in participants with detectable PD-L1
  • Overall survival (OS) in participants with detectable PD-L1
Secondary Outcome:
  • PFS as determined by an independent review committee (IRC) using RECIST v1.1
  • Percentage of participants with objective response as determined by the investigator using RECIST v1.1
  • Duration of response (DOR) as determined by the investigator using RECIST v1.1
  • Percentage of participants with objective response as determined by an IRC using RECIST v1.1
  • DOR as determined by an IRC using RECIST v1.1
  • PFS as determined by the investigator using modified RECIST criteria
  • Percentage of participants with objective response as determined by the investigator using modified RECIST criteria
  • DOR as determined by the investigator using modified RECIST criteria
  • PFS as determined by the investigator using RECIST v1.1 in all randomized participants and those with sarcomatoid histology
  • OS in participants with sarcomatoid histology
  • Change from Baseline in symptom interference as measured by M.D. Anderson Symptom Inventory (MDASI) scores
  • Change from Baseline in symptom severity as measured by MDASI scores
  • Change from Baseline in symptom severity as measured by Brief Fatigue Inventory (BFI) scores
  • Change from Baseline in treatment side effects as measured by Functional Assessment of Cancer Therapy Kidney Symptom Index (FSKI-19) subscale scores
  • Change from Baseline in health-related quality of life as measured by European Quality of Life 5-Dimension (EQ-5D) scores
  • Safety: Percentage of participants with adverse events
  • Safety: Percentage of participants with anti-therapeutic antibodies (ATAs) against atezolizumab
  • Pharmacokinetics: Maximum serum concentration (Cmax) of atezolizumab
  • Pharmacokinetics: Minimum serum concentration (Cmin) of atezolizumab
  • Pharmacokinetics: Cmax of bevacizumab
  • Pharmacokinetics: Cmin of bevacizumab

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society