OncRef

Clinical Trial: NCT02496208

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-10-15

Study Overview

Brief 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.

Official Title

A Phase 1 Study of Cabozantinib Plus Nivolumab (CaboNivo) Alone or in Combination With Ipilimumab (CaboNivoIpi) in Patients With Advanced/Metastatic Urothelial Carcinoma and Other 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

Intervention / Treatment

  • Procedure: Biopsy Procedure
  • Procedure: Biospecimen Collection
  • Drug: Cabozantinib S-malate
  • Procedure: Computed Tomography
  • Procedure: Echocardiography Test
  • Biological: Ipilimumab
  • Procedure: Magnetic Resonance Imaging
  • Biological: Nivolumab

Other Study ID Numbers

  • NCI-2014-02379
  • NCI-2014-02379
  • 15-C-0160
  • 150160
  • P141706
  • 9681
  • 9681
  • UM1CA186712
  • UM1CA186716
  • UM1CA186717
  • ZIABC011078

Start Date (Actual)

2015-07-22

Primary Completion Date (Estimated)

2027-07-30

Study Completion Date (Estimated)

2027-07-30

Enrollment (Estimated)

152

Study Type

Interventional

Phase

Phase 1