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Site for 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] (PSCI# 19-109) (A031704)

The purpose of this study is to compare the usual treatment of advanced kidney cancer (treatment with ipilimumab and nivolumab followed by nivolumab alone) to the usual treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if adding cabozantinib to nivolumab can increase the percentage of patients alive at 3 years from 60% to 70%.
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03793166
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Inclusion Criteria:
Histologic documentation of renal cell carcinoma with clear cell component
Age ≥ 18 years
Karnofsky performance status greater than or equal to 70%
Hemoglobin ≥8 g/dL
Platelet Count ≥ 100,000/mm3
Exclusion Criteria:
No prior previous systemic therapy for renal cell carcinoma.
No cancer therapy less than 28 days prior to registration; this includes radiation therapy.
Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
No history of HIV or active hepatitis B/C, or tuberculosis
No uncontrolled hypertension (systolic BP >150mmHg or diastolic BP
Cancer
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Study Locations

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Location
Hershey, PA