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Study identifier: NCT06571708 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Bladder Cancer · Muscle-Invasive Bladder Carcinoma  ·  Sponsor: Columbia University

PhasePhase 2
Planned participants36
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Alexander Z Wei, MD  ·  212-305-5874  ·  aw3056@cumc.columbia.edu

Nurse Navigator  ·  212-305-5098  ·  cancerclinicaltrials@cumc.columbia.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Columbia University Irving Medical Center/ New York Presbyterian HospitalNew York, New York, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06571708