A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy

Official Title

A Phase III, Multicentre, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti−PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy

Summary:

This is a Phase III, multicentre, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.

Trial Description

Primary Outcome:

  • Disease-Free Survival (DFS)
Secondary Outcome:
  • Overall Survival
  • DFS in Participants With Tumour-Infiltrating Immune Cell (IC) 1/2/3
  • Disease-Specific Survival
  • Distant Metastasis-Free Survival
  • Percentage of Participants Who Are Alive and Recurrence Free at Year 3
  • Percentage of Participants With Adverse Events
  • Maximum Serum Concentration (Cmax) of Atezolizumab
  • Minimum Serum Concentration (Cmin) of Atezolizumab
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Atezolizumab

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