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NCT06263153 · ClinicalTrials.gov registry record · Phase 2

Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy

A Phase 2 study of Muscle-Invasive Bladder Carcinoma and Bladder Urothelial Carcinoma, sponsored by Yuanquan Yang.

Recruiting
Registry status
Phase 2
Development phase
24
Enrollment target
3
Study locations

NCT06263153 is a Phase 2 study of Muscle-Invasive Bladder Carcinoma and Bladder Urothelial Carcinoma that is actively recruiting participants, run by Yuanquan Yang. The registered enrollment target is 24 participants, below the 124-participant average among 14 other Muscle-Invasive Bladder Carcinoma trials with a reported enrollment target (81% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT06263153, a Phase 2 study of Muscle-Invasive Bladder Carcinoma and Bladder Urothelial Carcinoma, is actively recruiting participants, sponsored by Yuanquan Yang.

RECRUITING
Registry status
Phase 2
Development phase
24 participants
Enrollment target
3
Study locations

Study Summary

This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based therapy. Cisplatin-based therapy is the standard of care for patients with MIBC. However, many patients cannot receive standard therapy due to poor renal function, peripheral neuropathy, poor functional status, or clinically significant heart failure. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Radical cystectomy is a surgery to remove all of the bladder as well as nearby tissues and organs. Giving futibatinib in combination with durvalumab before surgery may be an effective treatment option for patients with MIBC who are ineligible for cisplatin-based therapy.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • BIOLOGICAL Durvalumab
  • DRUG Futibatinib

Study Locations (3)

Ohio

  • Cleveland Clinic Taussig Cancer Center - Cleveland
  • Ohio State University Comprehensive Cancer Center - Columbus

Michigan

  • University of Michigan Comprehensive Cancer Center - Ann Arbor

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2024-12-30
Est. Completion 2026-12-31
Phase Phase 2

Sponsor

Yuanquan Yang

2 total trials

What the Registry Record Tells You About NCT06263153

The ClinicalTrials.gov registry entry for NCT06263153 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 124-participant average among 14 other Muscle-Invasive Bladder Carcinoma trials with a reported enrollment target (81% lower). The listed sponsor is Yuanquan Yang, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Muscle-Invasive Bladder Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06263153 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Ohio, Michigan.

Frequently Asked Questions

What is clinical trial NCT06263153 about?

NCT06263153 is a clinical study titled "Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy". This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based therapy. Cisplatin-based therapy is the standard of care for patients with MIBC. Howev...

What is the current status of trial NCT06263153?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2024-12-30. Estimated completion is 2026-12-31.

What conditions does trial NCT06263153 study?

This clinical trial studies the following conditions: Muscle-Invasive Bladder Carcinoma, Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8.

What interventions are being tested in trial NCT06263153?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Durvalumab (BIOLOGICAL), Futibatinib (DRUG).

Who is sponsoring clinical trial NCT06263153?

This trial is sponsored by Yuanquan Yang, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06263153 being conducted?

This trial has 3 study locations across Michigan, Ohio. 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.