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Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients

Study acronym: ALBAN
StatusActive, Not Recruiting
PhasePhase 3
SponsorUNICANCER
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 11, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Oct 2024 to Jun 2025 Enrollment target: estimated 516 to confirmed 517 · Study description shortened, about 1 wordv9 Show 2 more changesShow less
    • Enrollment target: estimated 516 to confirmed 517
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Apr 1, 2024 to Oct 2024 Primary endpoint revised · Completion date: Feb 1, 2028 to Oct 2028 · Secondary endpoints: 8 to 9v8 Show 3 more changesShow less
    • Primary endpoint revised
    • Completion date: Feb 1, 2028 to Oct 2028
    • Secondary endpoints: 8 to 9

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Site details revised at 38 of 38 sitesv7 Show 1 more changeShow less
    • Site details revised at 38 of 38 sites
  4. Primary completion date: Apr 1, 2022 to Apr 1, 2024 Study sites: 30 to 38 · Study description expanded, about 4 wordsv6 Show 2 more changesShow less
    • Study sites: 30 to 38
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 614 to 516 Study sites: 25 to 30 · Secondary endpoints revised (8) · Primary endpoint revised · 1 morev5 Show 4 more changesShow less
    • Study sites: 25 to 30
    • Secondary endpoints revised (8)
    • Primary endpoint revised
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 14 to 25 Eligibility criteria expanded, about 27 words · Secondary endpoints: details revised at 1 of 8 entriesv4 Show 2 more changesShow less
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 1 of 8 entries

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 1, 2019 to Jan 17, 2019 · Site details revised at 14 of 14 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Feb 1, 2019 to Jan 17, 2019
    • Site details revised at 14 of 14 sites
  3. Study title shortened, about 16 wordsv2 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.
UNICANCER
98 trials monitored
See 7 trials at risk
Bladder Cancer
1,022 trials monitored
See 71 trials at risk
This is an open-label, randomized, multicentric study in patients with high-risk non-muscle invasive bladder cancer who had never received BCG for this disease. The primary objective is to evaluate the efficacy of atezolizumab as measured by Event-Free survival.
Trial Details
NCT Number NCT03799835
Lead Sponsor UNICANCER
Collaborators: Hoffmann-La Roche
Conditions Bladder Cancer
Enrollment 517 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov