A Phase III Trial in Metastatic Untreated Renal Cell Cancer

July 16, 2019

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]

  • Clinical Trial Information

    Trial Contact: Walton, Sherri; Cevallos, Claudia

    Trial Phone: 321.841.1907 ; 321-841-2684

  • IRB No: A031704

    Protocol Abbrev: PDIGREE-A031704

    Principal Investigator: Julio J. Hajdenberg, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: PDIGREE

    Treatment: NIVOLUMAB AND IPILIMUMAB FOLLOWED BY NIVOLUMAB VS. CABOZANTINIB WITH NIVOLUMAB

    Therapies Involved: Oncology: 1st line

    ClinicalTrials.gov ID: NCT03793166

  • Objective

    This phase III trial studies how well nivolumab and ipilimumab, followed by nivolumab versus cabozantinib and nivolumab, work in treating patients with renal cell cancer that is untreated and has spread to other parts of the body

  • Key Eligibility

    Histologic documentation of renal cell carcinoma with clear
    cell component
    Metastatic disease
    Measurable disease
    Intermediate or poor risk per IDMC criteria
    CNS disease is allowed, if stable
    Karnofsky PS ≥ 70%
    No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents. No prior previous systemic therapy for renal cell carcinoma. No cancer therapy less than 28 days prior to registration; this includes radiation therapy, except for bone lesions less than 14 days prior to registration. There must be a complete recovery and no ongoing complications from radiotherapy
    Non-pregnant and non-nursing
    Age ≥18 years