A Phase III Study of Atezolizumab Immunotherapy plus Cabozantinib versus Cabozantinib Alone in Patients with Advanced Kidney Cancer that Grew after Immunotherapy

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Full Title

A 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 (WIRB)

Purpose

The purpose of this study is to see if treatment combining atezolizumab immunotherapy and cabozantinib is more effective than cabozantinib alone in patients with inoperable or metastatic renal cell carcinoma (RCC) that continued to grow during or after prior immunotherapy. Cabozantinib is already used to treat advanced kidney cancer. It is a pill that patients take themselves at home every day and works by inhibiting a number of pathways that cancer cells use to grow and spread. Atezolizumab boosts the power of the immune system to detect and destroy cancer cells. It is given as an infusion by vein, typically every 3 weeks.  Atezolizumab is approved for other cancers, but its use for treating kidney cancer is investigational.

Combining oral medications and immunotherapies has proven to be successful in people with kidney cancer who have not had prior therapy. This study is determining whether such success can also be achieved in patients who previously received other medications.

Patients in this study will be randomly assigned to receive cabozantinib alone or cabozantinib in combination with atezolizumab. The approach we are using is called “open label randomization,” meaning that patients and doctors will be aware of the treatment assignment once it is made; there is no placebo treatment in this study. 

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic RCC (clear cell RCC, papillary RCC, unclassified RCC, or RCC with sarcomatoid elements) that can be seen growing on imaging scans during or after treatment with checkpoint inhibitor immunotherapy (such as nivolumab, ipilimumab, pembrolizumab, or avelumab).
  • No more than two prior regimens of treatment may have been given for advanced cancer.
  • At least 4 weeks must pass between the completion of previous therapy and receipt of the study treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Martin Voss at 646-888-4721.

Protocol

21-093

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators