Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic 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 Cancer AJCC v8
• Stage III Renal Pelvis and Ureter 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy Procedure — PROCEDURE
  Undergo biopsies
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood
• Cabozantinib S-malate — DRUG
  Given PO
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Echocardiography Test — PROCEDURE
  Undergo echocardiography
• Ipilimumab — BIOLOGICAL
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Nivolumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Jul 22, 2015

Status verified

Mar 2026

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

152 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part I (cabozantinib s-malate, nivolumab)
  Patients receive cabozantinib s-malate PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 21 cycles, patients receive nivolumab IV over 30 minutes every 4 weeks in the absence of disease progression or unacceptable toxicity. After progression, patients may receive cabozantinib s-malate PO, nivolumab IV, and ipilimumab IV at the part II RP2D for 4 cycles followed by cabozantinib s-malate PO QD and nivolumab IV every 2 weeks or 4 weeks if post-cycle 21 in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography or magnetic resonance imaging and collection of blood samples throughout the trial. Patients may also undergo echocardiography at baseline and biopsies throughout the trial.
• Experimental: Part II (cabozantinib s-malate, nivolumab, ipilimumab)
  See detailed description.

Primary Outcome Measure

Recommended phase II dose (Phase I) [ Time Frame: Up to 4-6 weeks ]

Locations (8)

Find similar trials in Duarte, CA

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