Tests vepugratinib with standard drugs for bladder cancer that has spread
Tests vepugratinib with other cancer drugs in adults with advanced bladder cancer.
Plain-language title generated from the registry record
Registry title: A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
Key facts
- Where
- Aalborg, Aarhus, Copenhagen, and Næstved, DenmarkSee the 5 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or spread bladder (urothelial) cancer who have not had treatment for it and whose tumor has a certain FGFR3 gene change.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Urothelial cancer that cannot be removed by surgery, locally advanced or spread (metastatic), confirmed under the microscope, with disease that can be measured on scans. Mixed types are allowed if a urothelial part is present, except small cell or neuroendocrine cancer.
- Earlier treatment
- No earlier systemic (whole-body) treatment for locally advanced or metastatic urothelial cancer.
- Biomarker or test result
- A qualifying FGFR3 (fibroblast growth factor receptor 3) gene change found by testing a tumor or blood sample taken at or after the diagnosis of advanced or spread cancer.
Main reasons for not taking part
- Earlier systemic treatment for advanced or spread urothelial cancer
- Side effects above Grade 1 that remain from earlier treatment before or after surgery
- Nerve problems (sensory or motor neuropathy) of Grade 2 or higher
- Untreated or uncontrolled cancer in the brain or spinal cord area, or any past leptomeningeal disease
- Current corneal or retinal eye disorder found at the eye exam at screening
Read by machine on 9 November 2026.
Where in Denmark
- Aalborg Universitetshospital, SydAalborg, DenmarkNot yet recruiting
- Aarhus Universitetshospital, SkejbyAarhus, DenmarkNot yet recruiting
- Herlev and Gentofte HospitalCopenhagen, DenmarkNot yet recruiting
- RigshospitaletCopenhagen, DenmarkNot yet recruiting
- Næstved SygehusNæstved, DenmarkNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07218380EU 2025-522855-25-00
- Record updated
- 7 October 2026
- Original description
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.Read full original descriptionShow less
FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration
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.
Inclusion: Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small cell or neuroendocrine carcinoma are eligible if a urothelial component is present; Have a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration determined via molecular testing from a tumor or blood sample obtained at or any time after diagnosis of advanced or metastatic urothelial cancer; Have measurable disease by investigator assessment defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2; Have adequate laboratory parameters.
Exclusion: Have received prior systemic therapy for locally advanced or metastatic urothelial cancer (mUC); Have any unresolved toxicities greater than Grade 1 Common Terminology Criteria for Adverse Events ([CTCAE] version 5.0) from prior neoadjuvant or adjuvant systemic therapy; 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; Have ongoing sensory or motor neuropathy of Grade 2 or higher.