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A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 2 → 4 primary endpoints
See other at-risk trials from Merck KGaA

Record History

  1. Lead sponsor: EMD Serono Research & Development Institute, Inc. to EMD Serono Research & Development Institute, Inc. Study sites: 97 to 98 · Eligibility criteria expanded, about 14 words · Secondary endpoints: details revised at 20 of 20 entries · 1 more Show 4 more changesShow less
    • Study sites: 97 to 98
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 20 of 20 entries
    • Publications: details revised at 2 of 2 entries
  2. Primary endpoint(s) modified Results posted: Sep 1, 2026 · Completion pushed from Jun 25, 2026 to Jan 22, 2027 · Interventions modified · 2 morev18 Show 5 more changesShow less
    • Results posted: Sep 1, 2026
    • Completion pushed from Jun 25, 2026 to Jan 22, 2027
    • Interventions modified
    • Trial arms changed: 4 → 5
    • Secondary endpoints: 6 to 20

    See this version in full on ClinicalTrials.gov ↗

  3. 3 versions Re-verified since Oct 14, 2025, no change to tracked fieldsv15-v17
  4. Completion date: Jul 24, 2026 to Jun 25, 2026v14
  5. Study sites: 98 to 97 Primary completion date: Jan 23, 2025 to Jun 20, 2025 · Completion date: Jan 23, 2025 to Jul 24, 2026v13 Show 2 more changesShow less
    • Primary completion date: Jan 23, 2025 to Jun 20, 2025
    • Completion date: Jan 23, 2025 to Jul 24, 2026
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 108 to 98v12
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 252 to confirmed 256 · Study sites: 106 to 108v11 Show 2 more changesShow less
    • Enrollment target: estimated 252 to confirmed 256
    • Study sites: 106 to 108
  3. Re-verified, no change to tracked fieldsv10
  4. Study sites: 102 to 106v9
  5. Re-verified, no change to tracked fieldsv8
  6. Study sites: 100 to 102v7
  7. Primary completion date: Aug 5, 2026 to Jan 23, 2025 Study sites: 76 to 100 · Completion date: Aug 24, 2026 to Jan 23, 2025v6 Show 2 more changesShow less
    • Study sites: 76 to 100
    • Completion date: Aug 24, 2026 to Jan 23, 2025
  8. Study sites: 20 to 76 Eligibility criteria expanded, about 26 words · Secondary endpoints: details revised at 1 of 6 entriesv5 Show 2 more changesShow less
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 1 of 6 entries

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 8 to 20 Start date changed from estimate of Aug 15, 2022 to Aug 17, 2022v4 Show 1 more changeShow less
    • Start date changed from estimate of Aug 15, 2022 to Aug 17, 2022
  10. Trial status: Not Yet Recruiting to Recruiting Start date: May 4, 2022 to Aug 15, 2022 · Study sites: 7 to 8v3 Show 2 more changesShow less
    • Start date: May 4, 2022 to Aug 15, 2022
    • Study sites: 7 to 8
  11. Collaborator revisedv2 See this version in full on ClinicalTrials.gov ↗
  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.
Merck KGaA
43 trials monitored
See 4 trials at risk
Bladder Cancer
1,022 trials monitored
See 71 trials at risk
The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.
Trial Details
NCT Number NCT05327530
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany; Gilead Sciences; Nektar Therapeutics
Conditions Locally Advanced or Metastatic Urothelial Carcinoma
Enrollment 256 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov