deltatrials
Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT04658862

A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder (SunRISe-2)

A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy

Sponsor: Janssen Research & Development, LLC

Conditions Urinary Bladder Neoplasms
Interventions Cetrelimab Cisplatin Conventional radiation therapy Gemcitabine Hypo-fractioned radiation therapy TAR-200
Updated 54 times since 2021 Last updated: Feb 12, 2026 Started: Dec 7, 2020 Primary completion: Dec 30, 2026 Completion: Dec 31, 2028
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Urinary Bladder Neoplasms and is currently ongoing. Janssen Research & Development, LLC leads this study, which shows 54 recorded versions since 2020 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

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

Change History

54 versions recorded

  1. Feb 2026 — Present [monthly]

    Active Not Recruiting PHASE3

  2. Jan 2026 — Feb 2026 [monthly]

    Active Not Recruiting PHASE3

  3. Dec 2025 — Jan 2026 [monthly]

    Active Not Recruiting PHASE3

  4. Nov 2025 — Dec 2025 [monthly]

    Active Not Recruiting PHASE3

  5. Oct 2025 — Nov 2025 [monthly]

    Active Not Recruiting PHASE3

▶ Show 49 earlier versions

  1. Sep 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE3

  2. Aug 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE3

  3. Jul 2025 — Aug 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Jun 2025 — Jul 2025 [monthly]

    Active Not Recruiting PHASE3

  5. May 2025 — Jun 2025 [monthly]

    Active Not Recruiting PHASE3

  6. Apr 2025 — May 2025 [monthly]

    Active Not Recruiting PHASE3

  7. Mar 2025 — Apr 2025 [monthly]

    Active Not Recruiting PHASE3

  8. Feb 2025 — Mar 2025 [monthly]

    Active Not Recruiting PHASE3

  9. Jan 2025 — Feb 2025 [monthly]

    Active Not Recruiting PHASE3

  10. Nov 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  11. Oct 2024 — Nov 2024 [monthly]

    Recruiting PHASE3

  12. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE3

  13. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

  14. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE3

  15. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

  16. May 2024 — Jun 2024 [monthly]

    Recruiting PHASE3

  17. Apr 2024 — May 2024 [monthly]

    Recruiting PHASE3

  18. Mar 2024 — Apr 2024 [monthly]

    Recruiting PHASE3

  19. Feb 2024 — Mar 2024 [monthly]

    Recruiting PHASE3

  20. Jan 2024 — Feb 2024 [monthly]

    Recruiting PHASE3

  21. Dec 2023 — Jan 2024 [monthly]

    Recruiting PHASE3

  22. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE3

  23. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE3

  24. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE3

  25. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE3

  26. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE3

  27. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE3

  28. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE3

  29. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE3

  30. Feb 2023 — Apr 2023 [monthly]

    Recruiting PHASE3

  31. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE3

  32. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

  33. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  34. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE3

  35. May 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  36. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE3

  37. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  38. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE3

  39. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE3

  40. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  41. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  42. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE3

  43. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

  44. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  45. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  46. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE3

  47. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE3

  48. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE3

  49. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE3

    First recorded

Dec 2020

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Janssen Research & Development, LLC
Data source: Janssen Research & Development, LLC

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

Study Locations

A Coruña, Spain , Adana, Turkey (Türkiye) , Almada, Portugal , Amravati, India , Anderlecht, Belgium , Ankara, Turkey (Türkiye) , Ann Arbor, United States , Antwerp, Belgium , Arezzo, Italy , Assebroek, Belgium and 221 more locations