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Taking peoplePhase 3

Tests vepugratinib with standard drugs for bladder cancer that has spread

Tests vepugratinib with other cancer drugs in adults with advanced bladder cancer.

Key facts

Who runs it
Eli Lilly and Company
Where
Bari, Milan, Naples, Padova, Pisa, Roma, and Rome, ItalySee the 8 sitesAlso in 18 other countries, 268 sites
Registry title
A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
Status
Recruiting
Phase
Phase 3
People taking part
450 people, planned
Started
12 Dec 2025
Expected to end
May 2033
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Vepugratinib
  • Placebo
  • EV
  • Pembrolizumab
Record updated
7 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Italy

Also in 18 other countries, 268 sites

  • Instituto Tumori Giovanni Paolo IIBari, ItalyContact: Marica Gentile (principal investigator)Not yet recruiting
  • Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyContact: Giuseppe Procopio (principal investigator)Not yet recruiting
  • Ospedale San RaffaeleMilan, ItalyContact: Andrea Necchi (principal investigator)Not yet recruiting
  • Azienda Ospedaliera Universitaria Federico IINaples, ItalyContact: Luigi Formisano (principal investigator)Not yet recruiting
  • Istituto Oncologico Veneto - IRCCSPadova, ItalyContact: Marco Maruzzo (principal investigator)Not yet recruiting
  • Azienda Ospedaliera Universitaria PisanaPisa, ItalyContact: Luca Galli (principal investigator)Not yet recruiting
  • Fondazione Policlinico Universitario Agostino GemelliRoma, ItalyContact: Roberto Iacovelli (principal investigator)Not yet recruiting
  • Istituto Nazionale Tumori Regina ElenaRome, ItalyContact: Fabio Calabro (principal investigator)Not yet recruiting

About the trial

What the trial wants to find out

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

Vepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab.

Study participation could last up to approximately 6 years.

The 3 groups in the trial

  • Vepugratinib + EV + Pembrolizumab (Safety Lead In)Treatment being tested

    Vepugratinib administered orally with EV + pembrolizumab administered IV

    Treatment: Vepugratinib, EV, and Pembrolizumab

  • Vepugratinib + Enfortumab Vedotin (EV) + PembrolizumabTreatment being tested

    Vepugratinib administered orally, and EV + pembrolizumab administered by intravenous (IV) infusion.

    Treatment: Vepugratinib, EV, and Pembrolizumab

  • Placebo + EV + PembrolizumabPlacebo, for comparison

    Placebo administered orally, and EV + pembrolizumab administered by IV infusion.

    Treatment: Placebo, EV, and Pembrolizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests vepugratinib with standard drugs for bladder cancer that has spreadGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
7 October 2026