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 [PDIGREE]

About this Study

The purpose of this study is to compare the usual treatment (Ipilimumab and Nivolumab followed by Nivolumab alone) to treatment with Ipilimumab and Nivolumab with Cabozantinib in patient with untreated renal cell carcinoma that has spread to other parts of the body.

Sponsor Protocol ID:A031704
IRB Number:2019-0147
Actively Enrolling
Phase 3
June 30, 2022
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria
  • Histologically documented renal cell carcinoma with clear cell component, including patient who have sarcomatoid features
  • Any metastatic disease, including visceral. lymph node, other soft tissue and bone, measurable by RECIST 1.1
  • Must have intermediate of poor riskĀ 
  • No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents
  • No prior previous systemic therapy for renal cell carcinoma and prior adjuvant sunitinib
  • No cancer therapy less than 28 day prior to registrationm this includes radiation therapy
  • Not pregnant or not nursing

Exclusion Criteria
  • Active autoimmune disease requiring ongoing therapy
  • Ongoing acute toxicity greater than grade 2 from previous treatment
  • History of HIV or active hepatitis B/C, or active tuberculosis
  • Concurrent use of immunosuppressive medication including prednisone above 10 mg daily
  • Uncontrolled adrenal insufficiency
  • Uncontrolled hypertension
  • Major surgery less than 28 days prior to registration
  • Unstable cardiac arrhythmia within 6 months prior to registration
  • Moderate to severe hepatic impairment
  • Any arterial thrombotic events within 180 days prior to registration

Categories Click category to view its trials.
Kidney/Renal Conditions
Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Eulisa Goins-Freeman
Phone Number: 601-815-3936
Email: efreeman2@umc.edu
Principal Investigator:Henegan, John C, M.D.
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