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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06571708 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages