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NeoSTOP-IT: Bladder Cancer Study

This study is for adults with muscle-invasive bladder cancer (cancer that has grown into the bladder muscle). We want to see if adding the drugs cemiplimab and fianlimab to standard chemotherapy (gemcitabine and cisplatin) can better treat this type of cancer. Participants will be randomly assigned to receive either the chemotherapy plus cemiplimab and fianlimab, or chemotherapy plus cemiplimab alone. The main goal is to see how many participants have a complete response (no detectable cancer) after 16 weeks. We are looking for about 36 participants who are at least 18 years old and have a good general health status.

Study design
This is a Phase 2, open-label (everyone knows what treatment they are receiving), randomized study. About 36 participants will be randomly assigned to one of two treatment groups.
What's involved
You will undergo a procedure to remove the bladder tumor, then receive 4 cycles of treatment over 12 weeks. After treatment, you will have another procedure and imaging, and if you have a complete response, you will continue immunotherapy for 39 more weeks. You will have regular study visits on Day 1 and Day 8 of each three-week cycle.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, clinical complete response, is measured at 16 weeks. Participants with a complete response will continue immunotherapy for 39 weeks, for a total systemic treatment duration of 52 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06571708

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Columbia University
~36 participants
Updated 2025-09-02 on ClinicalTrials.gov
What's tested:GemcitabineCisplatinCemiplimabFianlimab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical Complete Response
Measured over 16 weeks

Conditions

Bladder Cancer
Muscle-Invasive Bladder Carcinoma

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NCT06571708

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Columbia University Irving Medical Center/ New York Presbyterian Hospital

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Alexander Z Wei, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Alexander Z Wei, MD
[email protected]
212-305-5874
Email the study team

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Eligibility criteria

Inclusion

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

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- treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible).
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.
Received bladder-directed radiation therapy previously for bladder cancer.
Received prior systemic chemotherapy for muscle-invasive bladder cancer.
Receiving any other investigational agents concurrently or within 4 weeks of start of treatment.
Had a solid organ or hematologic transplant.
Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at a dose greater than 10mg/day of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
Has a history of myocarditis.
Patients with another active second malignancy other than non-melanoma skin cancers.
Has a known history of, or any evidence of, interstitial lung disease or active noninfectious pneumonitis.
Has an active infection requiring systemic therapy.
History or current evidence of significant (Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.
Has a history of current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator, including dialysis.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.
Is pregnant or is a breastfeeding woman.

What this trial measures

  • Clinical Complete Response16 weeks

    Rate of clinical complete response after 4 cycles of neoadjuvant chemoimmunotherapy. Complete clinical response will be defined as: * No high-grade malignancy on repeat TURBT * No malignant cells on urine cytology * No definitive evidence of invasive local or metastatic disease on cross-sectional imaging (CT chest, abdomen, and pelvis with contrast or, if renal dysfunction, MRI with contrast) Cytoscopy and imaging should occur within 4 weeks of end of neoadjuvant therapy.