A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment

Official Title

A Phase III, Multicentre, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination With Cabozantinib Versus Cabozantinib Alone in Patients With Inoperable, Locally Advanced, or Metastatic Renal Cell Carcinoma Who Experienced Radiographic Tumour Progression During or After Immune Checkpoint Inhibitor Treatment

Summary:

This is a Phase III, multicentre, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumour progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.

Trial Description

Primary Outcome:

• Progression-Free Survival (PFS), as assessed by Independent Review Facility (IRF)
• Overall survival (OS)

• PFS Assessed by the Investigators (INV-PFS)
• Investigator Assessed Objective Response Rate (INV-ORR)
• IRF Assessed Objective Response Rate (IRF-ORR)
• Investigator Assessed Duration of Objective Response (INV-DOR)
• IRF Assessed DOR (IRF-DOR)
• Percentage of Participants With Adverse Events
• Atezolizumab Concentrations
• Cabozantinib Concentrations
• Prevalence of Anti-Drug Antibodies (ADAs) to Atezolizumab
• Incidence of ADAs to Atezolizumab During the Study

View this trial on ClinicalTrials.gov