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A Study of Risk Enabled Therapy After Neoadjuvant Immunochemotherapy for Bladder Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later May 2026 → May 2027
See other at-risk trials from Fox Chase Cancer Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from May 2026 to May 2027
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 3 of 3 entries
  2. Minor Re-verified, no change to tracked fieldsv10
  3. Notable Trial status: Suspended to Active, Not Recruiting
    • Primary completion date: May 2024 to May 2026
    • Enrollment target: estimated 71 to confirmed 81
    v9
  4. Stopped Trial status: Recruiting to Suspended Sponsor's reason: Slot availability
    • Primary completion date: Nov 2023 to May 2024
    • Site details revised at 4 of 4 sites
    v8
  5. Minor Study sites: 1 to 4v7
Show 5 earlier versionsHide 5 earlier versions
  1. Notable Primary completion date: Nov 2022 to Nov 2023
    • Study completion date: Nov 2023 to Nov 2028
    v6
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2021 to Dec 1, 2020
    • Site details revised
    v4
  4. Notable Start date: Nov 2020 to Feb 2021
    • Primary completion date: Aug 2022 to Nov 2022
    • Study completion date: Aug 2023 to Nov 2023
    v3
  5. Notable Start date: Aug 2020 to Nov 2020v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Neoadjuvant accelerated methotrexate/vinblastine/adriamycin/cisplatin (AMVAC) in combination with nivolumab is under evaluation for the treatment of muscle invasive bladder cancer (MIBC). Patients with pre-specified tumor mutations and complete clinical response with neoadjuvant therapy will preserve their bladders and go on active surveillance.
Trial Details
NCT Number NCT04506554
Lead Sponsor Fox Chase Cancer Center
Conditions
(from sponsor)
Muscle-Invasive Bladder Carcinoma
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov