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Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma

StatusActive, Not Recruiting
PhasePhase 3
SponsorBeiGene
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 1 of 46 sitesv34
  2. Re-verified, no change to tracked fieldsv33
  3. Trial status changed: Recruiting → Active, Not Recruiting Site details revised at 46 of 46 sitesv32 Show 1 more changeShow less
    • Site details revised at 46 of 46 sites
  4. Site details revised at 3 of 46 sitesv31
  5. Site details revised at 1 of 46 sitesv30
Show 28 earlier versionsHide 28 earlier versions
  1. Site details revised at 1 of 46 sitesv29
  2. Site details revised at 7 of 46 sitesv28
  3. Primary completion date: Jun 2027 to Jun 30, 2027 Completion date: Jun 2027 to Oct 21, 2027v27 Show 1 more changeShow less
    • Completion date: Jun 2027 to Oct 21, 2027
  4. Site details revised at 3 of 46 sitesv26
  5. Site details revised at 6 of 46 sitesv25
  6. Site details revised at 2 of 46 sitesv24
  7. Site details revised at 1 of 46 sitesv23
  8. Study sites revised (46)v22 See this version in full on ClinicalTrials.gov ↗
  9. Study sites: 40 to 46v21
  10. Study sites: 15 to 40v20
  11. Primary and study completion dates: Jan 2024 to Jun 2027v19
  12. Study sites: 30 to 15v18
  13. Site details revised at 1 of 30 sitesv17
  14. Study sites: 40 to 30v16
  15. Study sites: 41 to 40v15
  16. Primary and study completion dates: Jul 2022 to Jan 2024v14
  17. Site details revised at 2 of 41 sitesv13
  18. Study sites: 42 to 41v12
  19. Study sites: 40 to 42v11
  20. Interventions: Carboplatin (Drug), Carboplatin (Drug), Gemcitabine Hydrochloride (Drug), Placebo (Drug), Tislelizumab (Drug) to Carboplatin (Drug), Cisplatin (Drug), Gemcitabine Hydrochloride (Drug), Placebo (Drug), Tislelizumab (Drug)v10
  21. Primary endpoint revised Interventions: Cisplatin for Injection Carboplatin InjectionGemcitabine Gemcitabine Hydrochloride for Injection (Drug), Tislelizumab Cisplatin for… to Carboplatin (Drug), Carboplatin (Drug), Gemcitabine Hydrochloride (Drug), Placebo (Drug), Tislelizumab (Drug) · Site details revised at 2 of 40 sitesv9 Show 2 more changesShow less
    • Interventions: Cisplatin for Injection Carboplatin InjectionGemcitabine Gemcitabine Hydrochloride for Injection (Drug), Tislelizumab Cisplatin for… to Carboplatin (Drug), Carboplatin (Drug), Gemcitabine Hydrochloride (Drug), Placebo (Drug), Tislelizumab (Drug)
    • Site details revised at 2 of 40 sites

    See this version in full on ClinicalTrials.gov ↗

  22. Eligibility criteria expanded, about 10 words Site details revised at 6 of 40 sitesv8 Show 1 more changeShow less
    • Site details revised at 6 of 40 sites

    See this version in full on ClinicalTrials.gov ↗

  23. Primary endpoint revised Study sites: 36 to 40 · Eligibility criteria expanded, about 9 words · Secondary endpoints: details revised at 3 of 7 entries · 1 morev7 Show 4 more changesShow less
    • Study sites: 36 to 40
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 3 of 7 entries
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  24. Re-verified, no change to tracked fieldsv6
  25. Study sites: 2 to 36v5
  26. Re-verified, no change to tracked fieldsv4
  27. Start date: May 17, 2019 to May 29, 2019v3
  28. Start date changed from estimate of May 2019 to May 17, 2019v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
BeiGene
37 trials monitored
See 1 trial at risk
Bladder Cancer
1,022 trials monitored
See 71 trials at risk
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab + either cisplatin or carboplatin + gemcitabine versus placebo+ either cisplatin or carboplatin + gemcitabine in approximately 420 participants with locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy.
Trial Details
NCT Number NCT03967977
Lead Sponsor BeiGene
Conditions Urothelial Carcinoma
Enrollment 420 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov