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

NCT06571708 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-09-02

No results posted yet for this study

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

Interventions

DRUG

Gemcitabine

Gemcitabine 1000 mg/m\^2 IV

DRUG

Cisplatin

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

DRUG

Cemiplimab

Cemiplimab 350mg IV

DRUG

Fianlimab

Fianlimab 1600mg IV

Sponsors & Collaborators

Principal Investigators

  • Alexander Z Wei, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-14
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06571708 on ClinicalTrials.gov