A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma [IMmotion151]

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 multi-centre, randomized, open-label study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) 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 According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 (v1.1) in Participants with Detectable Programmed Death-Ligand 1 (PD-L1)
  • Overall Survival (OS) in all Randomized Participants
Secondary Outcome:
  • OS in Participants with Detectable PD-L1
  • PFS as Determined by an Independent Review Committee (IRC) According to RECIST v1.1
  • Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator According to RECIST v1.1
  • Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
  • Percentage of Participants With an Objective Response of CR or PR as Determined by an IRC According to RECIST v1.1
  • DOR as Determined by an IRC According to RECIST v1.1
  • PFS as Determined by the Investigator According to Modified RECIST
  • Percentage of Participants With an Objective Response of CR or PR as Determined by the Investigator According to Modified RECIST
  • DOR as Determined by the Investigator According to Modified RECIST
  • PFS in All Randomized Participants as Determined by the Investigator According to RECIST v1.1
  • PFS in Participants With Sarcomatoid Histology as Determined by the Investigator According to RECIST v1.1
  • OS in Participants With Sarcomatoid Histology
  • Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II
  • Change From Baseline in Symptom Severity as Determined by MDASI
  • Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI)
  • Change From Baseline in Treatment Side Effects Subscale From Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19)
  • Change From Baseline in Health-Related Quality of Life as Determined by European Quality of Life 5-Dimension (EQ-5D) Scores
  • Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs)
  • Percentage of Participants With Anti--Therapeutic Antibodies (ATAs) Against Atezolizumab
  • Maximum Serum Concentration (Cmax) for Atezolizumab
  • Minimum Serum Concentration (Cmin) for Atezolizumab
  • Cmax for Bevacizumab
  • Cmin for 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