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]
Categories (click each to see list of all clinical trials associated with that category): GU (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Teply, Benjamin
Eligibility: https://clinicaltrials.gov/study/NCT03793166?term=NCT03793166&rank=1
Summary
Primary objective
To compare the overall survival (OS) in patients with metastatic RCC treated with ipilimumabnivolumab followed by either nivolumab versus cabozantinib-nivolumab.
2.2 Secondary objective(s)
To determine PFS of patients treated with nivolumab versus nivolumab-cabozantinib
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)
To evaluate the rates of discontinuing therapy at 1 year
To compare objective response rates (ORR, assessed by RECIST 1.1 and iRECIST criteria) for patients treated with ipilimumab-nivolumab followed by cabozantinib-nivolumab versus ipilimumab-nivolumab followed by nivolumab.
To document the adverse event profile of ipilimumab-nivolumab followed by cabozantinibnivolumab.
2.3 Biomarker Studies:
To evaluate biomarkers associated with exceptional responses in both arms (exceptional responses defined as CRs with treatment discontinuation at 12 months or 24 months).
To evaluate whether baseline IL-6 is predictive of outcome in patients treated with
cabozantinib-containing regimen.
2.4 QOL Objectives
Primary QOL Objective
To compare health-related quality of life at 18 months post-registration as assessed
by the FKSI-19 between patients randomized to nivo vs cabo/nivo.
Secondary QOL Objectives
To compare health-related quality of life as assessed by the FKSI-19 between
patients randomized to nivo vs cabo/nivo at other time points.
To compare patient-reported fatigue using PROMIS-Fatigue between patients
randomized to nivo vs cabo/nivo.
To compare quality-adjusted survival (overall survival x utility score assessed by
EQ5D-5L) between patients randomized to nivo vs cabo/nivo.