deltatrials
Active Not Recruiting INTERVENTIONAL NCT03661320

A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer

Sponsor: Bristol-Myers Squibb

Updated 40 times since 2018 Last updated: Apr 10, 2026 Started: Nov 6, 2018 Primary completion: Feb 16, 2026 Completion: Dec 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Muscle-Invasive Bladder Cancer and Urinary Bladder Neoplasms and is currently ongoing. Bristol-Myers Squibb leads this study, which shows 40 recorded versions since 2018 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Apr 2019 · 4 months · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · 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 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Jan 2022 · 4 months · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Apr 2022 · 59 days · monthly snapshot~Apr 2022 – ~Jun 2022 · 2 months · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Dec 2022 · 5 months · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~Feb 2024 · 12 months · monthly snapshot~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jun 2025 · 9 months · monthly snapshot~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshot~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshot~Feb 2026 – ~Apr 2026 · 2 months · monthly snapshotApr 16, 2026 – Apr 17, 2026 · 1 days · daily APIApr 17, 2026 – present · 3 months · daily API

Change History

40 versions recorded
  1. Apr 17, 2026 — Present [daily]

    Active Not Recruiting

  2. Apr 16, 2026 — Apr 17, 2026 [daily]

    Active Not Recruiting

    Phase: PHASE3None

  3. Feb 2026 — Apr 2026 [monthly]

    Active Not Recruiting PHASE3

  4. Sep 2025 — Feb 2026 [monthly]

    Active Not Recruiting PHASE3

  5. Jun 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE3

Show 35 earlier versions
  1. Sep 2024 — Jun 2025 [monthly]

    Active Not Recruiting PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  3. Feb 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

  4. Feb 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  5. Dec 2022 — Feb 2023 [monthly]

    Recruiting PHASE3

  6. Jul 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  7. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  8. Apr 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

  9. Feb 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  10. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE3

  11. Sep 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  12. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  13. Nov 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  14. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE3

  15. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE3

  16. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE3

  17. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE3

  18. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE3

  19. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE3

  20. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE3

  21. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  22. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE3

  23. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE3

  24. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  25. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE3

  26. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  27. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

  28. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

  29. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE3

  30. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE3

  31. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

  32. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE3

  33. Dec 2018 — Apr 2019 [monthly]

    Recruiting PHASE3

  34. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  35. Oct 2018 — Nov 2018 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

Contact Information

Sponsor contact:
  • Bristol-Myers Squibb
  • Ono Pharmaceutical Co., Ltd.
Data source: ClinicalTrials.gov

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