Health Trials

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

ConditionsBladder AdenocarcinomaBladder Clear Cell AdenocarcinomaBladder Mixed AdenocarcinomaBladder Neuroendocrine CarcinomaBladder Small Cell Neuroendocrine CarcinomaBladder Squamous Cell CarcinomaChromophobe Renal Cell CarcinomaCollecting Duct CarcinomaInvasive Bladder Giant Cell Urothelial CarcinomaInvasive Bladder Lymphoepithelioma-Like CarcinomaInvasive Bladder Nested Urothelial CarcinomaInvasive Bladder Plasmacytoid Urothelial CarcinomaInvasive Bladder Sarcomatoid Urothelial CarcinomaInvasive Bladder Urothelial CarcinomaKidney Medullary CarcinomaLarge Cell Neuroendocrine CarcinomaMalignant Testicular Leydig Cell TumorMalignant Testicular Sertoli Cell TumorMetastatic Bladder CarcinomaMetastatic Bladder Clear Cell (Glycogen-Rich) Urothelial CarcinomaMetastatic Bladder Giant Cell Urothelial CarcinomaMetastatic Bladder Large Cell Neuroendocrine CarcinomaMetastatic Bladder Lipid-Rich Urothelial CarcinomaMetastatic Bladder Micropapillary Urothelial CarcinomaMetastatic Bladder Plasmacytoid Urothelial CarcinomaMetastatic Bladder Sarcomatoid Urothelial CarcinomaMetastatic Bladder Small Cell Neuroendocrine CarcinomaMetastatic Bladder Squamous Cell CarcinomaMetastatic Chromophobe Renal Cell CarcinomaMetastatic Kidney Medullary CarcinomaMetastatic Malignant Genitourinary System NeoplasmMetastatic Papillary Renal Cell CarcinomaMetastatic Penile CarcinomaMetastatic Prostate Small Cell Neuroendocrine CarcinomaMetastatic Sarcomatoid Renal Cell CarcinomaMetastatic Urethral CarcinomaPapillary Renal Cell CarcinomaSarcomatoid Renal Cell CarcinomaStage IV Bladder Cancer AJCC v8Stage IV Penile Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8Stage IV Urethral Cancer AJCC v8Stage IVB Prostate Cancer AJCC v8Urachal AdenocarcinomaUrethral Clear Cell Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

Qualifiers

One measurable site of disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1

One bone lesion on bone scan (tec99 or sodium fluoride [NaF] PET/CT, CT or MRI) for the bone-only cohort.

Small cell/ neuroendocrine carcinoma of the bladder (Cohort A)- All urothelial carcinomas with any amount of neuroendocrine differentiation (including small cell differentiation) will be included. If the tumor is purely neuroendocrine, metastasis from another site of origin should be clinically excluded

Adenocarcinoma of the bladder, or urachal adenocarcinoma, or bladder/urethra clear cell adenocarcinoma (Cohort B) - must be pure (per World Health Organization [WHO] definition), (i.e. urothelial carcinoma with glandular differentiation is not considered a pure adenocarcinoma

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Bone Scan
  • Cabozantinib S-malate
  • Computed Tomography
  • Echocardiography Test
  • Ipilimumab
  • Magnetic Resonance Imaging
  • Nivolumab
  • Positron Emission Tomography

Treatment groups

314 Participants
are divided into 1 treatment group

Sponsors and collaborators

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov