Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors

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.

Conditions

• Bladder 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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and urine sample collection

PROCEDURE

Bone Scan

Undergo bone scan

DRUG

Cabozantinib S-malate

Given PO

PROCEDURE

Computed Tomography

Undergo CT and/or PET/CT scan

PROCEDURE

Echocardiography Test

Undergo echocardiography

BIOLOGICAL

Ipilimumab

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT scan

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Andrea B Apolo · Alliance for Clinical Trials in Oncology

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-13

Primary Completion

2027-02-28

Completion

2027-02-28

FDA Drug

Yes

Countries

• United States
• Puerto Rico

Study Locations