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

Titre officiel

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

Sommaire:

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.

Description de l'essai

Primary Outcome:

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

Voir cet essai sur ClinicalTrials.gov

Intéressé(e) par cet essai?

Imprimez cette page et apportez-la chez votre médecin pour discuter de votre admissibilité à cet essai et des options de traitement. Seul votre médecin peut vous recommander pour un essai clinique.

Ressources

Société canadienne du cancer

Ces ressources sont fournies en partenariat avec Société canadienne du cancer