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

Summary

This phase I trial studies the side effects and best doses of cabozantinib s-malate and nivolumab with or without ipilimumab in treating patients with genitourinary (genital and urinary organ) tumors that have spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib s-malate 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. It is not yet known whether giving cabozantinib s-malate and nivolumab alone or with ipilimumab works better in treating patients with genitourinary tumors.

Conditions

• Bladder Small Cell Neuroendocrine Carcinoma
• Bladder Squamous Cell Carcinoma
• Bladder Urothelial Carcinoma
• Clear Cell Renal Cell Carcinoma
• Invasive Bladder Plasmacytoid Urothelial Carcinoma
• Invasive Bladder Sarcomatoid Urothelial Carcinoma
• Invasive Sarcomatoid Urothelial Carcinoma
• Kidney Medullary Carcinoma
• Malignant Genitourinary System Neoplasm
• Malignant Solid Neoplasm
• Penile Carcinoma
• Penile Squamous Cell Carcinoma
• Renal Cell Carcinoma
• Renal Pelvis Urothelial Carcinoma
• Sarcomatoid Renal Cell Carcinoma
• Stage III Bladder Cancer AJCC v8
• Stage III Penile Cancer AJCC v8
• Stage III Renal Cell Cancer AJCC v8
• Stage III Renal Pelvis and Ureter Cancer AJCC v8
• Stage III Renal Pelvis Cancer AJCC v8
• Stage III Ureter Cancer AJCC v8
• Stage III Urethral Cancer AJCC v8
• Stage IV Bladder Cancer AJCC v8
• Stage IV Penile Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8
• Stage IV Renal Pelvis and Ureter Cancer AJCC v8
• Stage IV Ureter Cancer AJCC v8
• Stage IV Urethral Cancer AJCC v8
• Ureter Urothelial Carcinoma
• Urethral 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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Andrea B Apolo · National Cancer Institute LAO

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-22

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• United States

Study Locations