CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 314 target
Drug / intervention
Cabozantinib S-malate +8 moredrug
Likely dose
Not stated in record
Key inclusion· 11
  • ✓Metastatic disease with at least one measurable site (RECIST v1.1) or one bone lesion on imaging
  • ✓Histologically confirmed metastatic disease in one of specified cohorts (A-L)
  • ✓Age 18 years or older
  • ✓Able to swallow oral tablets
Key exclusion· 40
  • ✕Prior treatment with cabozantinib
  • ✕Prior PD-1/PD-L1/CTLA-4 inhibitors if also received prior MET or VEGFR inhibitors
  • ✕Prior checkpoint inhibitor therapy except in urothelial carcinoma cohorts (D, H, J, L)
  • ✕Evidence of active or acute diverticulitis, intra-abdominal abscess, GI obstruction within 12 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03866382
NCT03866382Phase 2RecruitingHigh Momentum
Long Recruiting
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A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

National Cancer Institute (NCI)·interventional·Posted Mar 7, 2019·Updated Jun 26, 2026

In Brief

A Phase 2 clinical trial evaluating Biospecimen Collection, Bone Scan, and 7 other interventions for Bladder Adenocarcinoma and 44 related conditions. Currently recruiting, targeting 314 participants across 581 sites in 2 countries.

Signals

Enrolling ahead of pace

Detailed Summary

This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma, Bladder Mixed Adenocarcinoma, Bladder Neuroendocrine Carcinoma, Bladder Small Cell Neuroendocrine Carcinoma, Bladder Squamous Cell Carcinoma, Chromophobe Renal Cell Carcinoma, Collecting Duct Carcinoma, Invasive Bladder Giant Cell Urothelial Carcinoma, Invasive Bladder Lymphoepithelioma-Like Carcinoma, Invasive Bladder Nested Urothelial Carcinoma, Invasive Bladder Plasmacytoid Urothelial Carcinoma, Invasive Bladder Sarcomatoid Urothelial Carcinoma, Invasive Bladder Urothelial Carcinoma, Kidney Medullary Carcinoma, Large Cell Neuroendocrine Carcinoma, Malignant Testicular Leydig Cell Tumor, Malignant Testicular Sertoli Cell Tumor, Metastatic Bladder Carcinoma, Metastatic Bladder Clear Cell (Glycogen-Rich) Urothelial Carcinoma, Metastatic Bladder Giant Cell Urothelial Carcinoma, Metastatic Bladder Large Cell Neuroendocrine Carcinoma, Metastatic Bladder Lipid-Rich Urothelial Carcinoma, Metastatic Bladder Micropapillary Urothelial Carcinoma, Metastatic Bladder Plasmacytoid Urothelial Carcinoma, Metastatic Bladder Sarcomatoid Urothelial Carcinoma, Metastatic Bladder Small Cell Neuroendocrine Carcinoma, Metastatic Bladder Squamous Cell Carcinoma, Metastatic Chromophobe Renal Cell Carcinoma, Metastatic Kidney Medullary Carcinoma, Metastatic Malignant Genitourinary System Neoplasm, Metastatic Papillary Renal Cell Carcinoma, Metastatic Penile Carcinoma, Metastatic Prostate Small Cell Neuroendocrine Carcinoma, Metastatic Sarcomatoid Renal Cell Carcinoma, Metastatic Urethral Carcinoma, Papillary Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage IV Bladder Cancer AJCC v8, Stage IV Penile Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, Stage IV Urethral Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Urachal Adenocarcinoma, Urethral Clear Cell Adenocarcinoma
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2Recruiting
201920202021202220232024202520262027
First PostedMar 7, 2019
Enrollment StartMay 13, 2019
Primary CompletionFeb 28, 2027
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 7.3 years agoPrimary completion in 8 months

Arms & Interventions

Treatment (cabozantinib, nivolumab, ipilimumab)experimental

Patients receive cabozantinib PO QD on days 1-21 of cycles 1-4 and on days 1-28 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 90 minutes on day 1 of cycles 1-4. Patients then receive nivolumab IV over 30 minutes on day 1 of subsequent cycles. Treatment repeats every 21 days for cycles 1-4 and every 28 days for subsequent cycles for 2 years in the absence of disease progression or unacceptable toxicity. Patients may undergo echocardiography during screening and undergo CT or MRI, bone scan and blood and urine sample collection throughout the trial and may undergo PET/CT throughout the trial.

Procedure: Biospecimen CollectionProcedure: Bone ScanDrug: Cabozantinib S-malateProcedure: Computed TomographyProcedure: Echocardiography TestBiological: IpilimumabProcedure: Magnetic Resonance ImagingBiological: NivolumabProcedure: Positron Emission Tomography

Interventions

Biospecimen Collectionprocedure

Undergo blood and urine sample collection

Bone Scanprocedure

Undergo bone scan

Cabozantinib S-malatedrug

Given PO

Computed Tomographyprocedure

Undergo CT and/or PET/CT scan

Echocardiography Testprocedure

Undergo echocardiography

Ipilimumabbiological

Given IV

Magnetic Resonance Imagingprocedure

Undergo MRI

Nivolumabbiological

Given IV

Positron Emission Tomographyprocedure

Undergo PET/CT scan