A PHASE II STUDY OF IPILIMUMAB , CABOZANTINIB, AND NIVOLUMAB IN RARE GENITOURINARY CANCERS (ICONIC)
Categories (click each to see list of all clinical trials associated with that category): Genitourinary (GU)
Current Status: Open to accrual
Phase: II
Principal Investigator: Teply, Benjamin
Contact Information:
Jamie Willms
+1 402-559-8649
jamie.willms@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03866382?cond=NCT03866382&draw=2&rank=1#eligibility
Summary
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of cabozantinib s-malate (cabozantinib) combined with nivolumab and ipilimumab in the first or second-line (and beyond) setting for patients within each of the rare genitourinary (GU) variant histology group of interest, as measured by objective response rate (ORR).
SECONDARY OBJECTIVES:
I. To estimate the progression-free survival (PFS) for patients treated with cabozantinib combined with nivolumab and ipilimumab within each rare variant histology.
II. To estimate the overall survival (OS) for patients treated with cabozantinib combined with nivolumab and ipilimumab within each rare variant histology.
III. To estimate the clinical benefit rate (defined as complete response [CR] or partial response [PR] or stable disease [SD]) for patients treated with cabozantinib combined with nivolumab and ipilimumab within each rare variant histology.
IV. To assess the safety of treating patients with rare variant histologies with cabozantinib combined with nivolumab and ipilimumab.
V. To support tissue banking and collection of clinical follow-up data for GU tract rare histological variants.
EXPLORATORY OBJECTIVES:
I. To assess effects of treatment in patients with bone-only disease by bone scan.