A031702 (ICONIC): A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers

About this Study

The purpose of this study is to see how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread to other places in the body.

Sponsor Protocol ID:A031702
IRB Number:2019-0132
Actively Enrolling
Phase 2
June 30, 2022
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria
  • New metastatic lesion(s) or progressive lesion(s) on imaging or bone scan
  • Histologically confirmed diagnosis of bladder cancer, urothelial carcinoma, penile cancer, sarcomatoid renal cell, sarcomatoid urothelial carcinoma, bone only urothelial carcinoma, other non-prostate GU tumor, or urethra carcinoma
  • May have received up to 2 systemic anti-cancer treatment or never received treatment at all
  • Must be able to swallow pills
  • Prior treatment with any therapy on the PD-1/PD-L1 

Exclusion Criteria
  • Prior cabozantinib
  • Evidence of active or acute diverticulitis, intra-abdominal abscess, and gastrointestinal (GI) obstruction, within 12 months
  • Pregnant
  • Received any type of investigational agent within 14 prior to first dose of study treatment
  • Active brain metastases or epidural disease
  • Treatment with warfarin (blood thinner)
  • Uncontrolled, significant intercurrent or recent illness such as:  cardiovascular disorder, significant gastrointestional disorders associated with a high risk of perforation (tearing) of fistula
  • Major surgery within 3 months of the first dose of treatment

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Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Eulisa Goins-Freeman
Phone Number: 601-815-3936
Email: efreeman2@umc.edu
Principal Investigator:Henegan, John C, M.D.
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