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A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
Sponsor: Eli Lilly and Company
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2025-12-12
Completion Date
2033-05
Last Updated
2026-10-07
Healthy Volunteers
No
Interventions
Vepugratinib
Administered orally
Placebo
Administered orally
EV
Administered by IV infusion
Pembrolizumab
Administered by IV infusion
Locations (276)
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine
Irvine, California, United States
TRIO-US (Translational Research in Oncology-US)
Los Angeles, California, United States
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, United States
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, United States
UCSF Medical Center at Mission Bay
San Francisco, California, United States
Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer (TMPN)
Torrance, California, United States
AdventHealth Medical Group - Porter
Denver, Colorado, United States
Colorado West Healthcare System - Grand Valley Oncology
Grand Junction, Colorado, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
AdventHealth Orlando
Orlando, Florida, United States
St. Luke's Cancer Institute: Boise
Boise, Idaho, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Endeavor Health
Evanston, Illinois, United States
Accellacare of Duly
Lisle, Illinois, United States
Parkview Research Center at Parkview Regional Medical Center
Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Franciscan Health
Indianapolis, Indiana, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center - Metairie
Metairie, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
James M Stockman Cancer Institute
Frederick, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Brigitte Harris Cancer Pavilion
Detroit, Michigan, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Columbia University Irving Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Wilmot Cancer Institute
Rochester, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Oncology Specialists of Charlotte
Charlotte, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, United States
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Avera Cancer Institute- Research
Sioux Falls, South Dakota, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
USO-Texas Oncology-Central/South Texas
Austin, Texas, United States
World Research Link
Baytown, Texas, United States
Parkland Health and Hospital System
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Nova Oncology
McAllen, Texas, United States
US Oncology Research Network
The Woodlands, Texas, United States
USO - Texas Oncology - Northeast Texas
Tyler, Texas, United States
USO - Virginia Oncology Associates
Norfolk, Virginia, United States
Box Hill Hospital
Box Hill, Australia
Mater Misericordiae Limited
Brisbane, Australia
GenesisCare - Campbelltown
Campbelltown, Australia
Austin Health
Heidelberg, Australia
Macquarie University
Macquarie University, Australia
Sir Charles Gairdner Hospital
Perth, Australia
Prince of Wales Hospital
Randwick, Australia
Western Health-Sunshine & Footscray Hospitals
St Albans, Australia
Calvary Mater Newcastle
Waratah, Australia
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, Brazil
CPAM - Centro de Pesquisas da Amazônia
Belém, Brazil
Hospital Tacchini
Bento Gonçalves, Brazil
IOP Pesquisa
Curitiba, Brazil
Hospital de Cancer de Londrina
Londrina, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, Brazil
Instituto de Oncologia Saint Gallen
Santa Cruz do Sul, Brazil
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, Brazil
Hospital BP
São Paulo, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Canada
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec, Canada
BC Cancer Vancouver
Vancouver, Canada
Peking University First Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Beijing Cancer hospital
Beijing, China
Beijing GoBroad Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
Xiangya Hospital Central South University
Changsha, China
Hunan Cancer Hospital
Changsha, China
West China Hospital, Sichuan University
Chengdu, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Chongqing University Cancer Hospital
Chongqing, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China