NCT02496208View on ClinicalTrials.gov

Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

July 22, 2015

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Bladder Small Cell Neuroendocrine CarcinomaBladder Squamous Cell CarcinomaBladder Urothelial CarcinomaClear Cell Renal Cell CarcinomaInvasive Bladder Plasmacytoid Urothelial CarcinomaInvasive Bladder Sarcomatoid Urothelial CarcinomaInvasive Sarcomatoid Urothelial CarcinomaKidney Medullary CarcinomaMalignant Genitourinary System NeoplasmMalignant Solid NeoplasmPenile CarcinomaPenile Squamous Cell CarcinomaRenal Cell CarcinomaRenal Pelvis Urothelial CarcinomaSarcomatoid Renal Cell CarcinomaStage III Bladder Cancer AJCC v8Stage III Penile Cancer AJCC v8Stage III Renal Cell Cancer AJCC v8Stage III Renal Pelvis and Ureter Cancer AJCC v8Stage III Renal Pelvis Cancer AJCC v8Stage III Ureter Cancer AJCC v8Stage III Urethral Cancer AJCC v8Stage IV Bladder Cancer AJCC v8Stage IV Penile Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8Stage IV Renal Pelvis and Ureter Cancer AJCC v8Stage IV Ureter Cancer AJCC v8Stage IV Urethral Cancer AJCC v8Ureter Urothelial CarcinomaUrethral Urothelial Carcinoma
Interventions
PROCEDURE

Biopsy Procedure

Undergo biopsies

PROCEDURE

Biospecimen Collection

Undergo collection of blood

DRUG

Cabozantinib S-malate

Given PO

PROCEDURE

Computed Tomography

Undergo CT scan

PROCEDURE

Echocardiography Test

Undergo echocardiography

BIOLOGICAL

Ipilimumab

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

Trial Locations (8)

20892

National Institutes of Health Clinical Center, Bethesda

NCI - Center for Cancer Research, Bethesda

43210

Ohio State University Comprehensive Cancer Center, Columbus

90033

Los Angeles General Medical Center, Los Angeles

USC / Norris Comprehensive Cancer Center, Los Angeles

91010

City of Hope Comprehensive Cancer Center, Duarte

95817

University of California Davis Comprehensive Cancer Center, Sacramento

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH