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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].

Primary Objective:
To compare the overall survival (OS) in patients with metastatic RCC treated with ipilimumabnivolumab followed by either nivolumab versus cabozantinib-nivolumab.

Secondary Objective(s):
a. To determine PFS of patients treated with nivolumab versus nivolumab-cabozantinib;
b. To evaluate the 12-month complete response rate in patients treated with ipilimumabnivolumab followed by cabozantinib-nivolumab versus ipilimumab-nivolumab followed by nivolumab (patients who have CR and relapse before 12 months will not be counted as a CR at 12-months);
c. To evaluate the rates of discontinuing therapy at 1 year;
d. To compare objective response rates (ORR, assessed by RECIST 1.1 and irRECIST criteria) for patients treated with ipilimumab-nivolumab followed by cabozantinib-nivolumab versus ipilimumab-nivolumab followed by nivolumab;
e. To document the adverse event profile of ipilimumab-nivolumab followed by cabozantinibnivolumab.

Protocol Number: 081910
Phase: Phase III
Applicable Disease Sites: Kidney
Drugs Involved: Opdivo (Nivolumab)
IPILIMUMAB (MDX-010)
Cabozantinib (XL184)
Principal Investigator: Biren Saraiya M.D
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Chemotherapy multiple agents systemic
Participating Institutions:
  • Rutgers Cancer Institute of New Jersey
  • RWJBarnabas Health
    • Cooperman Barnabas, Livingston
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

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