Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Blad… (NCT06571708) | Clinical Trial Compass
RecruitingPhase 2
Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
United States36 participantsStarted 2025-08-14
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion 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.
* Histologically confirmed muscle-invasive urothelial carcinoma of the bladder defined as T2-T3, N0, M0 stage. Mixed histology is permitted if there is a urothelial component. Upper tract disease in not permitted.
* Prior Bacillus Calmette-Guerin (BCG) or other intravesical treatment of non-muscle invasive bladder cancer is permitted if completed at least 6 weeks prior to initiating study treatment. Only one course (includes induction + maintenance) of BCG or intravesical therapy is permitted.
* No metastatic disease based on cross-sectional imaging.
* Considered cisplatin eligible based on protocol specified criteria.
* Not received any adjuvant or neoadjuvant chemotherapy or immunotherapy.
* Agree to pre- and post-treatment TURBT as well as surveillance with cystoscopies, cross-sectional imaging, and urine cytology unless medically contraindicated in the opinion of the treating physician, and discussed with the principal investigator
Exclusion Criteria:
* Concurrent upper urinary tract (i.e., ureter, renal pelvis) invasive urothelial carcinoma. (NOTE: Patients with history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post- treatme…