Actively Recruiting
A Phase 2, Randomized, Open-label Study of Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab for Organ Preservation in Localized Muscle-invasive Bladder Cancer
Led by Columbia University · Updated on 2025-09-02
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether combining gemcitabine, cisplatin, and cemiplimab with or without fianlimab can treat adults with localized muscle-invasive bladder cancer. This phase 2, open-label, randomized trial aims to determine if these drug combinations can improve organ preservation in this condition while monitoring safety using Bayesian toxicity methods. Participants will be randomly assigned to receive either gemcitabine, cisplatin, and cemiplimab or the same combination with added fianlimab. Treatment includes 4 cycles of chemotherapy and immunotherapy over 12 weeks, followed by a repeat bladder tumor resection and imaging. Those showing a complete response continue maintenance immunotherapy for 13 additional cycles, totaling 52 weeks of systemic treatment including neoadjuvant and adjuvant phases, with recovery periods between treatments. Throughout the study, participants will have regular visits for safety and response assessments including lab tests, vital signs, physical exams, cystoscopy, urine cytology, and imaging scans every three months to check for disease spread or recurrence. The main outcome measured is clinical complete response at 16 weeks, with additional monitoring of adverse events, bladder-intact survival, recurrence-free survival, and overall survival for up to five years.
CONDITIONS
Brief 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 on the day of signing informed consent.
- Life expectancy greater than 12 months.
- ECOG performance status of 0 or 1.
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder (T2-T3, N0, M0 stage).
- Mixed histology allowed if there is a urothelial component.
- Prior Bacillus Calmette-Guerin (BCG) or other intravesical treatment for non-muscle invasive bladder cancer permitted if completed at least 6 weeks before study treatment.
- No metastatic disease based on imaging.
- Eligible for cisplatin treatment based on 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).
- Prior treatment with immune checkpoint inhibitors or other specified immunotherapies.
- Previous bladder-directed radiation therapy for bladder cancer.
- Prior systemic chemotherapy for muscle-invasive bladder cancer.
- Receiving other investigational agents concurrently or within 4 weeks before treatment.
- History of solid organ or hematologic transplant.
- Active or recent autoimmune disease requiring systemic immunosuppressive treatment within 2 years.
- Diagnosis of immunodeficiency or systemic steroid therapy >10 mg/day prednisone equivalent within 14 days before trial treatment.
- History of myocarditis.
- Another active second malignancy except non-melanoma skin cancer.
- Known or suspected interstitial lung disease or active noninfectious pneumonitis.
- Active infection requiring systemic therapy.
- Recent significant infection requiring antibiotics within 2 weeks before trial treatment.
- Conditions or therapies that could interfere with trial participation or outcomes.
- Psychiatric or substance abuse disorders interfering with study cooperation.
- Uncontrolled HIV, hepatitis B or C infection.
- Pregnant or breastfeeding women.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment including medical history, physical examination, and baseline imaging
Duration - 12 weeks
Participants receive 4 cycles of neoadjuvant chemotherapy and immunotherapy over 12 weeks, with gemcitabine, cisplatin, and cemiplimab with or without fianlimab. Treatment includes Day 1 and Day 8 visits each 3-week cycle in the neoadjuvant phase for safety and response assessments.
8 visits (in-person) on Day 1 and Day 8 of each 3-week cycle
Duration - Up to 4 weeks
Participants have up to 4 weeks off treatment to recover after neoadjuvant therapy before cystoscopy and possible TURBT procedure.
1 to 2 visits depending on clinical assessments
Duration - 1 week
Participants undergo cystoscopy and TURBT if residual disease is present to assess treatment response.
1 visit (in-person) for cystoscopy and possible TURBT
Duration - Up to 4 weeks
Participants have up to 4 weeks off treatment to recover after cystoscopy/TURBT before starting adjuvant immunotherapy.
1 visit (in-person) for assessment
Duration - Up to 39 weeks
Participants achieving clinical complete response receive maintenance immunotherapy with cemiplimab (and fianlimab if assigned) every 3 weeks for up to 39 weeks (13 cycles). Visits include Day 1 of each 3-week cycle for safety and response monitoring.
Up to 13 visits (in-person) every 3 weeks
Duration - Throughout treatment period
Participants undergo regular cystoscopy and urine cytology every 3 months while on treatment to monitor disease status. Imaging scans are performed at baseline and every 3 months during adjuvant therapy.
Regular visits every 3 months for cystoscopy, urine cytology, and imaging
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
N
Nurse Navigator
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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