Alliance-A031704/PDIGREE (Renal Cell Cancer)

What is the Purpose of this Study?

We are doing this study to compare the usual treatment alone (treatment with ipilimumab and nivolumab followed by nivolumab alone) to the usual treatment with ipilimumab and nivolumab, follwed by nivolumab and cabozantinib.

What is the Condition Being Studied?

Metastatic Untreated Renal Cell Cancer

Who Can Participate in the Study?

Adults 18 years or older with metastatic untreated renal cell cancer who:

  • Have histologic diagnosis of renal cell carcinoma with clear cell component
  • Have measurable disease
  • Are not pregnant or nursing
Age Group

What is Involved?

If you agree to be in the study you will:

  • Be treated with a combination immunotherapy of nivolumab and ipilimumab.
  • Have a scan and further treatment will be determined by the results of the scan.
    • Group A: Patients will get nivolumab by IV every four weeks until disease worsens.
    • Group B: Patients will get nivolumab by IV every four weeks in combination with cabozantinib taken by mouth, until disease worsens.

Study Details

Full Title
Alliance-A031704: PD-Inhibitor (Nivolumab) and Ipilimumab followed by Nivolumab VS. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated Renal Cell Cancer [PEDIGREE]
Principal Investigator
George Barth Geller Distinguished Professor for Research in Cancer
Protocol Number
IRB: PRO00102937
NCT: NCT03793166
Phase III
Enrollment Status