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

StatusActive, Not Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 10 months later Sep 30, 2026 → Jul 30, 2027
See other at-risk trials from National Cancer Institute (NCI)

Record History

The 50 most recent of 165 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 30, 2026 to Jul 30, 2027 Show 5 more changesShow less
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description revised
    • Site details revised at 1 of 8 sites
    • Publications: details revised at 3 of 3 entries
  2. 30 versions Re-verified since Sep 2, 2025, no change to tracked fieldsv135-v164
  3. Study description expanded, about 35 wordsv134
  4. Re-verified, no change to tracked fieldsv133
  5. Interventions: Biopsy (Procedure), Biospecimen Collection (Procedure), Cabozantinib S-malate (Drug), Computed Tomography (Procedure), Echocardiography… to Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Cabozantinib S-malate (Drug), Computed Tomography (Procedure)…v132
Show 16 earlier versionsHide 16 earlier versions
  1. Primary and study completion dates: Sep 30, 2024 to Sep 30, 2026v131
  2. 5 versions Re-verified since Feb 6, 2024, no change to tracked fieldsv126-v130
  3. Study sites revised (8)v125
  4. 2 versions Re-verified since Nov 7, 2023, no change to tracked fieldsv123-v124
  5. Primary and study completion dates: Sep 30, 2023 to Sep 30, 2024v122
  6. Re-verified, no change to tracked fieldsv121
  7. Start date: Jul 9, 2015 to Jul 22, 2015
    • Interventions: Biospecimen Collection (Procedure), Cabozantinib S-malate (Drug), Computed Tomography (Procedure), Ipilimumab (Biological), Magnetic… to Biopsy (Procedure), Biospecimen Collection (Procedure), Cabozantinib S-malate (Drug), Computed Tomography (Procedure), Echocardiography…
    • Eligibility criteria shortened, about 27 words
    • Study description expanded, about 29 words
    v120
  8. 3 versions Re-verified since Mar 7, 2023, no change to tracked fieldsv117-v119
  9. Interventions: Cabozantinib S-malate (Drug), Ipilimumab (Biological), Nivolumab (Biological) to Biospecimen Collection (Procedure), Cabozantinib S-malate (Drug), Computed Tomography (Procedure), Ipilimumab (Biological), Magnetic…
    • Eligibility criteria expanded, about 50 words
    • Study description expanded, about 31 words
    v116
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02496208
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 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 +22 more
Related terms Carcinoma, Renal Cell, Penile Neoplasms, Ureteral Neoplasms, Urethral Neoplasms, Urinary Bladder Neoplasms, Urogenital Neoplasms
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov