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

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 trea

Trial Details

NCT ID
NCT06571708
Phase
PHASE2
Sponsor
Columbia University
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • Gemcitabine
  • Cisplatin
  • Cemiplimab
  • Fianlimab
Locations (sample)
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Willing and able to provide written informed consent for the trial.
  • Age ≥18 years of age on day of signing informed consent.
  • Life expectancy \> 12 months.
  • Performance status of 0-1 using the Eastern Cooperative Oncology Group (ECOG) Performance Scale.

For full eligibility, visit ClinicalTrials.gov.

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