RecruitingPhase 2NCT06571708

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

A Phase 2, Randomized, Open-label Study of Gemcitabine/Cisplatin Plus Cemiplimab (REGN2810, Anti-PD-1) With or Without Fianlimab (REGN3767, Anti-LAG-3) for Organ Preservation in Patients With Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)

Sponsor

Columbia University

Enrollment

36 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

Muscle-Invasive Bladder Carcinoma Bladder Cancer

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a second immunotherapy drug called fianlimab to a standard combination of gemcitabine, cisplatin, and cemiplimab (given before bladder removal surgery) improves outcomes for people with muscle-invasive bladder cancer. The goal is to shrink tumors before surgery and reduce the chance of cancer returning. **You may be eligible if:** - You are 18 or older with confirmed muscle-invasive bladder cancer (stage T2-T3, no spread to lymph nodes or other organs) - Your cancer is confirmed to be urothelial carcinoma (mixed histology allowed if urothelial is present) - You are eligible for cisplatin-based chemotherapy - Your general health is good (ECOG 0-1) with a life expectancy over 12 months - Prior BCG or intravesical therapy for non-muscle invasive bladder cancer is allowed if completed at least 6 weeks before starting the study **You may NOT be eligible if:** - Your cancer has spread to distant parts of the body (metastatic) - You have upper urinary tract disease - You are not eligible for cisplatin (due to kidney or hearing problems) - You are pregnant or breastfeeding - You have had more than one course of BCG or intravesical therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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