OncoMatch/Clinical Trials/NCT06571708
Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
Is NCT06571708 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Gemcitabine and Cisplatin for bladder cancer.
Treatment: Gemcitabine · Cisplatin · Cemiplimab · Fianlimab — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immune checkpoint inhibitor
Received prior immune checkpoint inhibitors (including anti-PD-1, anti-PD-L1, anti-CTLA4, anti-LAG-3 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways ), as well as cellular vaccines, cellular therapies, or systemic oncolytic virus therapy.
Cannot have received: radiation therapy
Received bladder-directed radiation therapy previously for bladder cancer.
Cannot have received: systemic chemotherapy
Received prior systemic chemotherapy for muscle-invasive bladder cancer.
Cannot have received: adjuvant chemotherapy
Not received any adjuvant or neoadjuvant chemotherapy or immunotherapy.
Cannot have received: neoadjuvant chemotherapy
Not received any adjuvant or neoadjuvant chemotherapy or immunotherapy.
Cannot have received: adjuvant immunotherapy
Not received any adjuvant or neoadjuvant chemotherapy or immunotherapy.
Cannot have received: neoadjuvant immunotherapy
Not received any adjuvant or neoadjuvant chemotherapy or immunotherapy.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Columbia University Irving Medical Center/ New York Presbyterian Hospital · New York, New York
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