deltatrials
Active Not Recruiting PHASE1 INTERVENTIONAL 2-arm NCT02496208

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

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

Sponsor: National Cancer Institute (NCI)

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
Interventions Biopsy Procedure Biospecimen Collection Cabozantinib S-malate Computed Tomography Echocardiography Test Ipilimumab Magnetic Resonance Imaging Nivolumab
Updated 59 times since 2017 Last updated: Mar 12, 2026 Started: Jul 22, 2015 Primary completion: Sep 30, 2026 Completion: Sep 30, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Bladder Small Cell Neuroendocrine Carcinoma and Bladder Squamous Cell Carcinoma, this trial is ongoing. The trial is conducted by National Cancer Institute (NCI) and has accumulated 59 data snapshots since 2015. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~Jun 2017 · 2 months · monthly snapshot~Jun 2017 – ~Sep 2017 · 3 months · monthly snapshot~Sep 2017 – ~Dec 2017 · 3 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Nov 2018 · 2 months · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~Jun 2019 · 2 months · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Jun 2020 · 4 months · monthly snapshot~Jun 2020 – ~Aug 2020 · 2 months · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Apr 2021 · 59 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~May 2022 · 6 months · monthly snapshot~May 2022 – ~Jul 2022 · 2 months · monthly snapshot~Jul 2022 – ~Nov 2022 · 4 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~Apr 2023 · 59 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Oct 2023 · 5 months · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Mar 2025 · 5 months · monthly snapshot~Mar 2025 – ~May 2025 · 2 months · monthly snapshot~May 2025 – ~Sep 2025 · 4 months · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Mar 2026 · 5 months · monthly snapshot~Mar 2026 – present · 4 months · monthly snapshot

Change History

59 versions recorded

  1. Mar 2026 — Present [monthly]

    Active Not Recruiting PHASE1

  2. Oct 2025 — Mar 2026 [monthly]

    Active Not Recruiting PHASE1

  3. Sep 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE1

  4. May 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE1

  5. Mar 2025 — May 2025 [monthly]

    Active Not Recruiting PHASE1

▶ Show 54 earlier versions

  1. Oct 2024 — Mar 2025 [monthly]

    Active Not Recruiting PHASE1

  2. Sep 2024 — Oct 2024 [monthly]

    Active Not Recruiting PHASE1

  3. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Jul 2024 — Aug 2024 [monthly]

    Active Not Recruiting PHASE1

  5. May 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1

  6. Apr 2024 — May 2024 [monthly]

    Active Not Recruiting PHASE1

  7. Mar 2024 — Apr 2024 [monthly]

    Active Not Recruiting PHASE1

  8. Feb 2024 — Mar 2024 [monthly]

    Active Not Recruiting PHASE1

  9. Jan 2024 — Feb 2024 [monthly]

    Active Not Recruiting PHASE1

  10. Dec 2023 — Jan 2024 [monthly]

    Active Not Recruiting PHASE1

  11. Nov 2023 — Dec 2023 [monthly]

    Active Not Recruiting PHASE1

  12. Oct 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE1

  13. May 2023 — Oct 2023 [monthly]

    Active Not Recruiting PHASE1

  14. Apr 2023 — May 2023 [monthly]

    Active Not Recruiting PHASE1

  15. Feb 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE1

  16. Dec 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE1

  17. Nov 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE1

  18. Jul 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE1

  19. May 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE1

  20. Nov 2021 — May 2022 [monthly]

    Active Not Recruiting PHASE1

  21. Oct 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  22. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE1

  23. May 2021 — Sep 2021 [monthly]

    Recruiting PHASE1

  24. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE1

  25. Feb 2021 — Apr 2021 [monthly]

    Recruiting PHASE1

  26. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1

  27. Oct 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  28. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE1

  29. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE1

  30. Jun 2020 — Aug 2020 [monthly]

    Recruiting PHASE1

  31. Feb 2020 — Jun 2020 [monthly]

    Recruiting PHASE1

  32. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE1

  33. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE1

  34. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE1

  35. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE1

  36. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE1

  37. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE1

  38. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE1

  39. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE1

  40. Apr 2019 — Jun 2019 [monthly]

    Recruiting PHASE1

  41. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE1

  42. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE1

  43. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE1

  44. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE1

  45. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE1

  46. Sep 2018 — Nov 2018 [monthly]

    Recruiting PHASE1

  47. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE1

  48. Jun 2018 — Aug 2018 [monthly]

    Recruiting PHASE1

  49. Dec 2017 — Jun 2018 [monthly]

    Recruiting PHASE1

  50. Sep 2017 — Dec 2017 [monthly]

    Recruiting PHASE1

  51. Jun 2017 — Sep 2017 [monthly]

    Recruiting PHASE1

  52. Apr 2017 — Jun 2017 [monthly]

    Recruiting PHASE1

  53. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE1

  54. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1

    First recorded

Jul 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations