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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: Recruiting Phase 2 study of Muscle-Invasive Bladder Carcinoma and Bladder Urothelial Carcinoma, sponsored by Yuanquan Yang.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be defined by a percentage of participants with ypT0N0 by pathologic responses.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-12-30 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT06263153 shows while recruiting
NCT06263153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 124-participant average among 14 other Muscle-Invasive Bladder Carcinoma trials with a reported enrollment target (81% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Muscle-Invasive Bladder Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06263153's enrollment target sits among peer trials
24 12th of 14 higher than 3 of 14 other Muscle-Invasive Bladder Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Muscle-Invasive Bladder Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
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