Actively Recruiting
Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
Led by Columbia University · Updated on 2025-09-02
36
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent for the trial.
- Age 18 years or older at the time of consent.
- Life expectancy greater than 12 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder, stage T2-T3, N0, M0. Mixed histology allowed if urothelial component present.
- Prior Bacillus Calmette-Guerin (BCG) or intravesical treatment for non-muscle invasive bladder cancer allowed if completed at least 6 weeks before study treatment, limited to one course.
- No metastatic disease on cross-sectional imaging.
- Eligible for cisplatin treatment according to protocol criteria.
- No prior adjuvant or neoadjuvant chemotherapy or immunotherapy.
- Agree to pre- and post-treatment TURBT and surveillance with cystoscopies, imaging, and urine cytology unless medically contraindicated.
You will not qualify if you...
- Concurrent invasive urothelial carcinoma of the upper urinary tract (ureter, renal pelvis), except treated non-invasive upper tract disease with no residual disease.
- Prior treatment with immune checkpoint inhibitors or related therapies.
- Previous bladder-directed radiation therapy.
- Prior systemic chemotherapy for muscle-invasive bladder cancer.
- Use of other investigational agents within 4 weeks before treatment.
- History of solid organ or hematologic transplant.
- Active or recent (within 2 years) autoimmune disease requiring immunosuppressive treatment, except certain controlled conditions.
- Diagnosis of immunodeficiency or use of systemic immunosuppressive therapy exceeding 10 mg/day prednisone equivalent within 14 days before first dose; inhaled or topical steroids allowed.
- History of myocarditis.
- Active second malignancy other than non-melanoma skin cancer.
- Known interstitial lung disease or active noninfectious pneumonitis.
- Active infection requiring systemic therapy.
- Significant infection requiring antibiotics within 2 weeks before first dose.
- Conditions or abnormalities that may interfere with trial participation or outcomes, including dialysis.
- Psychiatric or substance abuse disorders interfering with cooperation.
- Uncontrolled HIV, hepatitis B or C infection, or immunodeficiency related to chronic infection.
- Pregnant or breastfeeding women.
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Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center/ New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
Research Team
A
Alexander Z Wei, MD
CONTACT
N
Nurse Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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