Renal Cell WO41994 (GU)

Phase III, Multicenter, 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 Tumor Progression During Or After Immune Checkpoint Inhibitor Treatment.

This is a Phase III, multicenter, 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 tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.

Eligibility Criteria:
  • Advanced, metastatic RCC clear cell or non-clear cell (papillary or unclassified), including sarcomatoid
  • Radiographic progression on or after prior ICI
    • ICI in 1L or 2L as single agent or combination with VEGFR-TKI or another ICI (e.g., ipilimumab)
    • ICI in immediate preceding line of therapy
  • Patients who have experienced radiographic progression during or after one immune checkpoint inhibitor (ICI) treatment for locally advanced or metastatic RCC, either in 1L or 2L
    • ICI is defined by anti-PD-L1 or anti-PD-1 antibody (e.g. ipilimumab monotherapy is not ICI in this case)
    • No more than 2 prior lines of therapy in the metastatic setting
    • The ICI must be administered in the immediate preceding line of therapy
This study is for patients age 18 and older. 
Available at: Hartford HealthCare, Hospital of Central Connecticut, Midstate Medical Center, William Backus Hospital.

Cancer Clinical Research Office