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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood and urine sample collection
• Bone Scan — PROCEDURE
  Undergo bone scan
• Cabozantinib S-malate — DRUG
  Given PO
• Computed Tomography — PROCEDURE
  Undergo CT and/or PET/CT scan
• Echocardiography Test — PROCEDURE
  Undergo echocardiography
• Ipilimumab — BIOLOGICAL
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Nivolumab — BIOLOGICAL
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT scan

Study Details

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.

Key Dates

Start date

May 13, 2019

Status verified

Feb 2026

Primary completion

Feb 28, 2027

Completion

Feb 28, 2027

Study Design

Enrollment

314 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (cabozantinib, nivolumab, ipilimumab)
  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.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 5 years ]

Locations (578)

Find similar trials in Birmingham, AL

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