A Phase III Trial in Metastatic Untreated Renal Cell Cancer
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: Djuro, Victor; Walton, Sherri
Trial Phone: 321.841.7477 ; 321.841.1907
-
IRB No: A031704
Protocol Abbrev: PDIGREE-A031704
Principal Investigator:
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
