At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Vepugratinib (drug), Placebo (other), EV (drug), Pembrolizumab (drug)
- How long the study runs
- Study runs about 89 months (dates as stated)
- About the drug or intervention
- Vepugratinib — drug: Administered orally · Placebo — other: Administered orally · EV — drug: Administered by IV infusion · Pembrolizumab — drug: Administered by IV infusion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 450
- Started
- 2025-12-12
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for carcinoma, transitional cell
- • Phase3 - 450 participants
- • The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with carcinoma, transitional cell
Where?
- • Huddersfield - Huddersfield Royal Infirmary
- • London - St Bartholomew's Hospital
- • London - University College London Hospital
- • London - Royal Marsden Hospital (Sutton)
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread. Vepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab. Study participation could last up to approximately 6 years.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Have cancer that can be measured on scans by investigator assessment defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- ✓Have an activity scale (ECOG) performance status of 0 to 2.
- ✓Have adequate laboratory parameters
Who cannot take part
- ✗Have received prior treatment that goes through your whole body for that has grown locally or that has spread urothelial cancer (mUC).
- ✗Have any unresolved toxicities greater than Grade 1 Common Terminology Criteria for Adverse Events (\[CTCAE\]...
- ✗Have ongoing sensory or motor neuropathy of Grade 2 or higher
- ✗Have untreated or uncontrolled central nervous system (CNS) involvement or any history of leptomeningeal disease.
- ✗Current evidence corneal keratopathy or retinal disorder confirmed by ocular examination at screening.
See the full criteria
Where Is This Study? (7 UK sites)
Huddersfield Royal Infirmary
Huddersfield HD3 3EA, United Kingdom
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
University College London Hospital
London NW1 2PG, United Kingdom
Royal Marsden Hospital (Sutton)
London SM2 5PT, United Kingdom
Royal Marsden Hospital (Chelsea)
London SW3 6JJ, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Weston Park Hospital
Sheffield S10 2SJ, United Kingdom
How to Get in Touch
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Sponsor contactCONTACT
Physicians interested in becoming principal investigators please contact
Sponsor contactCONTACT