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Taking people in United StatesPhase 3

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
Austin, Baltimore, Baton Rouge, Baytown, Boise, Boston, Charlotte, Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, East Brunswick, Evanston, Fort Wayne, Frederick, Grand Junction, Houston, Indianapolis, Irvine, Lancaster, Las Vegas, Lexington, Lisle, Little Rock, Los Angeles, McAllen, Metairie, Nashville, New Haven, New Orleans, New York, Norfolk, Orange, Orlando, Pittsburgh, Portland, Rochester, Sacramento, San Francisco, Sioux Falls, Springfield, St Louis, The Woodlands, Torrance, Tucson, Tyler, Washington D.C., Winston-Salem, and Worcester, United StatesSee the 64 sites
Phase
Phase 3

Where in United States

  • USO-Texas Oncology-Central/South TexasAustin, United StatesTaking people
  • Johns Hopkins HospitalBaltimore, United StatesTaking people
  • Mary Bird Perkins Cancer CenterBaton Rouge, United StatesTaking people
  • World Research LinkBaytown, United StatesTaking people
  • St. Luke's Cancer Institute: BoiseBoise, United StatesNot yet recruiting
  • Massachusetts General HospitalBoston, United StatesNot yet recruiting
  • Levine Cancer InstituteCharlotte, United StatesNot yet recruiting
  • Oncology Specialists of CharlotteCharlotte, United StatesTaking people
  • University of Chicago Medical CenterChicago, United StatesNot yet recruiting
  • University of Illinois at ChicagoChicago, United StatesTaking people
  • University of Cincinnati Medical CenterCincinnati, United StatesNot yet recruiting
  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -TColumbus, United StatesNot yet recruiting
  • Parkland Health and Hospital SystemDallas, United StatesNot yet recruiting
  • UT Southwestern Medical CenterDallas, United StatesTaking people
  • AdventHealth Medical Group - PorterDenver, United StatesNot yet recruiting
  • Brigitte Harris Cancer PavilionDetroit, United StatesNot yet recruiting
  • Karmanos Cancer InstituteDetroit, United StatesTaking people
  • Astera Cancer CareEast Brunswick, United StatesTaking people
  • Endeavor HealthEvanston, United StatesNot yet recruiting
  • Parkview Research Center at Parkview Regional Medical CenterFort Wayne, United StatesTaking people
  • James M Stockman Cancer InstituteFrederick, United StatesNot yet recruiting
  • Colorado West Healthcare System - Grand Valley OncologyGrand Junction, United StatesTaking people
  • University of Texas - MD Anderson Cancer CenterHouston, United StatesTaking people
  • Franciscan HealthIndianapolis, United StatesTaking people
  • Indiana University/Melvin and Bren Simon Cancer CenterIndianapolis, United StatesTaking people
  • Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - IrvineIrvine, United StatesTaking people
  • Lancaster General Hospital - Ann B Barshinger Cancer InstituteLancaster, United StatesNot yet recruiting
  • Comprehensive Cancer Centers of NevadaLas Vegas, United StatesTaking people
  • University of Kentucky Chandler Medical CenterLexington, United StatesNo longer taking part
  • Accellacare of DulyLisle, United StatesNot yet recruiting
  • University of Arkansas for Medical SciencesLittle Rock, United StatesNot yet recruiting
  • TRIO-US (Translational Research in Oncology-US)Los Angeles, United StatesTaking people
  • UCLA Hematology/Oncology - Santa MonicaLos Angeles, United StatesTaking people
  • Nova OncologyMcAllen, United StatesTaking people
  • Mary Bird Perkins Cancer Center - MetairieMetairie, United StatesTaking people
  • Sarah Cannon Research InstituteNashville, United StatesTaking people
  • SCRI Oncology PartnersNashville, United StatesTaking people
  • Tennessee OncologyNashville, United StatesTaking people
  • Yale New Haven HospitalNew Haven, United StatesNot yet recruiting
  • Ochsner Clinic FoundationNew Orleans, United StatesNot yet recruiting
  • Columbia University Irving Medical CenterNew York, United StatesTaking people
  • Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
  • Weill Cornell Medical CollegeNew York, United StatesNot yet recruiting
  • USO Virginia Oncology AssociatesNorfolk, United StatesTaking people
  • University of California, Irvine (UCI) Health - UC Irvine Medical CenterOrange, United StatesTaking people
  • AdventHealth OrlandoOrlando, United StatesNot yet recruiting
  • AHN Allegheny General HospitalPittsburgh, United StatesTaking people
  • Kaiser Permanente Interstate Medical Office CentralPortland, United StatesTaking people
  • Oregon Health and Science UniversityPortland, United StatesNot yet recruiting
  • Providence Portland Medical CenterPortland, United StatesTaking people
  • Providence St. Vincent Medical CenterPortland, United StatesTaking people
  • Wilmot Cancer InstituteRochester, United StatesNot yet recruiting
  • University of California Davis (UC Davis) Comprehensive Cancer CenterSacramento, United StatesTaking people
  • UCSF Medical Center at Mission BaySan Francisco, United StatesTaking people
  • Avera Cancer Institute- ResearchSioux Falls, United StatesTaking people
  • Oncology Hematology AssociatesSpringfield, United StatesTaking people
  • Washington University School of MedicineSt Louis, United StatesTaking people
  • US Oncology Research NetworkThe Woodlands, United StatesTaking people
  • Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer (TMPN)Torrance, United StatesTaking people
  • The University of Arizona Cancer Center-North CampusTucson, United StatesTaking people
  • USO - Texas Oncology - Northeast TexasTyler, United StatesTaking people
  • MedStar Washington Hospital CenterWashington D.C., United StatesNot yet recruiting
  • Wake Forest Baptist HealthWinston-Salem, United StatesNot yet recruiting
  • University of Massachusetts Medical SchoolWorcester, United StatesNot yet recruiting

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?
Print a page for my doctor

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.

ClinicalTrials.gov NCT07218380 · EU CTIS 2025-522855-25-00