Recruiting

Phase 2

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

Sponsor:

Columbia University

Code:

NCT06571708

Conditions

Bladder Cancer

Muscle-Invasive Bladder Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gemcitabine

Cisplatin

Cemiplimab

Fianlimab

Study Details

Brief 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).

Conditions

Bladder Cancer

Muscle-Invasive Bladder Carcinoma

Study ID

NCT06571708

Start date

Aug 14, 2025

Status verified date

Aug, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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- 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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: Gemcitabine/Cisplatin/Cemiplimab

Gemcitabine 1000 mg/m\^2 IV (days 1 and 8 of 21 day for 4 cycles)
Cisplatin 70 mg/m\^2 IV (day 1 of 21 day cycle for 4 cycles) or renally-dosed split-dose -cisplatin 35 m/m\^2 IV (day 1 and 8 of 21 day cycle for 4 cycles)
Cemiplimab (REGN 2810) 350 mg IV every 3 weeks (17 cycles)

experimental: Group 2: Gemcitabine/Cisplatin/Cemiplimab/Fianlimab

Gemcitabine 1000 mg/m2 IV (days 1 and 8 of 21 day cycle for 4 cycles)
Cisplatin 70 mg/m2 IV (day 1 of 21 day cycle for 4 cycles) or renally-dosed split-dose cisplatin 35 m/m2 IV (day 1 and 8 of 21 day cycle for 4 cycles )
Cemiplimab (REGN 2810) 350mg IV every 3 weeks (4 cycles)
Fianlimab (REGN3767) 1600mg IV every 3 weeks (4 cycles)

Interventions

Gemcitabine

Gemcitabine 1000 mg/m\^2 IV

Cisplatin

Cisplatin 70 mg/m\^2 IV or renally-dosed split-dose cisplatin 35 m/m\^2 IV

Cemiplimab

Cemiplimab 350mg IV

Fianlimab

Fianlimab 1600mg IV

Primary outcome measure

Clinical Complete Response [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Alexander Z Wei, MD

212-305-5874 aw3056@cumc.columbia.edu

Nurse Navigator

212-305-5098 cancerclinicaltrials@cumc.columbia.edu

Locations

Columbia University Irving Medical Center/ New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Alexander Z Wei, MD

212-305-5874 aw3056@cumc.columbia.edu

Nurse Navigator

212-305-5098 cancerclinicaltrials@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Sep 2, 2025

Last verified

Aug, 2025

Keywords

Urothelial Predominant Histology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-09-02.