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Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)

Study acronym: NeoSTOP-IT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 2025 to Aug 14, 2025 · Site details revisedv5 Show 2 more changesShow less
    • Start date changed from estimate of Jul 2025 to Aug 14, 2025
    • Site details revised
  2. Start date: Jun 2025 to Jul 2025 Study site revisedv4 Show 1 more changeShow less
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Nov 2024 to Jun 2025v3
  4. Eligibility criteria expanded, about 17 words Study title shortened, about 9 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to learn if gemcitabine/cisplatin plus cemiplimab with or without fianlimab works to treat bladder cancer in adults. The main question it aims to answer is: Can gemcitabine, cisplatin, and cemiplimab with or without fianlimab treat bladder cancer? Participants will be randomly selected (like the loss of a coin) to treatment with gemcitabine, cisplatin, cemiplimab, and fianlimab or gemcitabine, cisplatin, and cemiplimab. Participants will: * Undergo transurethral resection of bladder tumor (TURBT) followed by the start of treatment, receive 4 cycles of treatment (21 day cycles) * After 4 cycles of treatment, patients will undergo repeat maximal TURBT with imaging * Participants with a complete response will continue maintenance cemiplimab or cemiplimab/fianlimab for 13 more cycles with imaging every 3 months * Participants without a complete clinical response will undergo cystectomy (bladder surgery).
Trial Details
NCT Number NCT06571708
Lead Sponsor Columbia University
Collaborators: Regeneron Pharmaceuticals
Conditions Bladder Cancer, Muscle-Invasive Bladder Carcinoma
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov