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NCT06571708 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Bladder Cancer and Muscle-Invasive Bladder Carcinoma, sponsored by Columbia University.

Recruiting
Registry status
Phase 2
Development phase
36
Enrollment target
1
Study location

NCT06571708 is a Phase 2 study of Bladder Cancer and Muscle-Invasive Bladder Carcinoma that is actively recruiting participants, run by Columbia University. The registered enrollment target is 36 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06571708, a Phase 2 study of Bladder Cancer and Muscle-Invasive Bladder Carcinoma, is actively recruiting participants, sponsored by Columbia University.

RECRUITING
Registry status
Phase 2
Development phase
36 participants
Enrollment target
1
Study location

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 Studied

Bladder Cancer Muscle-Invasive Bladder Carcinoma

Interventions

  • DRUG Cemiplimab
  • DRUG Cisplatin
  • DRUG Gemcitabine
  • DRUG Fianlimab

Study Locations (1)

New York

  • Columbia University Irving Medical Center/ New York Presbyterian Hospital - New York

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2025-08-14
Est. Completion 2028-12
Phase Phase 2

Sponsor

Columbia University

958 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06571708

The ClinicalTrials.gov registry entry for NCT06571708 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 4 interventions - of which Cemiplimab is the first listed.

NCT06571708 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT06571708 about?

NCT06571708 is a clinical study titled "Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)". 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 wil...

What is the current status of trial NCT06571708?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2025-08-14. Estimated completion is 2028-12.

What conditions does trial NCT06571708 study?

This clinical trial studies the following conditions: Bladder Cancer, Muscle-Invasive Bladder Carcinoma.

What interventions are being tested in trial NCT06571708?

The interventions under investigation include: Cemiplimab (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), Fianlimab (DRUG).

Who is sponsoring clinical trial NCT06571708?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06571708 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.