CONTACT-03: Cabozantinib +/- Atezolizumab for locally advanced or metastatic Renal Cell Carcinoma

What is the Purpose of this Study?

If you choose to be in this study, you will:
- Take (cabozantinib) pills three times per day
- Be assigned to one of two groups:
- One group will get a drug called atezolizumab (which is given through a needle in a vein in your arm) every three weeks
- The other group will not receive atezolizumab
- Have blood and urine tests
- Have a tumor biopsy taken (You may be able to send a piece of a tumor biopsy you have already had)
- Have imaging scans
- Complete questionnaires
What is the Condition Being Studied?
Locally Advanced or Metastatic Renal Cell Carcinoma

Who Can Participate in this Study?

Adults who have:

- Locally advanced or metastatic renal cell carcinoma

- Already received an immunotherapy drug

Age Group
Adults
Participating Institutions

What is Involved?

We are doing this study to learn how safe and effective taking two study drugs (called cabozantinib and atezolizumab) is compared to taking just cabozantinib alone.

We will compare how effective the study drug(s) are by taking images of your tumor every 9 weeks to see if it is growing, and we will compare how safe the study drug(s) are by seeing what side effects that people have while taking them.

The study will also learn more about how long the study drug(s) stay in your body and how your immune system responds to them.

Study Details

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
Principal Investigator

Protocol Number
IRB:
PRO00106429

NCT:
NCT04338269
ClinicalTrials.gov
View on ClinicalTrials.gov