AzTrials
AzTrials

Carcinoma, Transitional CellPhase 3FORAGER-2NCT07218380

A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract

A Phase 3 study testing Vepugratinib, EV and Pembrolizumab in people with Carcinoma, Transitional Cell and Urinary Bladder Neoplasms, run by Eli Lilly and Company at 276 sites in 19 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vepugratinib, EV and Pembrolizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
276 sitesin 19 countries
Study dates
12 Dec 2025to May 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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 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.

Trial locations and contacts

276 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

276 sites in 19 countries

United States64 sites, 63 recruiting

  • USO-Texas Oncology-Central/South Texas

    Austin, Texas, 78731

    Michael Lattanzi

    Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

    Jean Hoffman-Censits

    Recruiting

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

    225-215-1185

    Victor Lin

    Recruiting

  • World Research Link

    Baytown, Texas, 77521

    833-832-8328

    Amir Rasheed

    Recruiting

  • St. Luke's Cancer Institute: Boise

    Boise, Idaho, 83712

    Peyman Haghighat

    Not yet recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    617-724-4000

    Xin Gao

    Not yet recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

    980-442-6410

    Earle Burgess

    Not yet recruiting

  • Oncology Specialists of Charlotte

    Charlotte, North Carolina, 28207

    Nasfat Shehadeh

    Recruiting

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

    Karine Tawagi

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    773-702-1152

    Randy Sweis

    Not yet recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Robert Franklin

    Not yet recruiting

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T

    Columbus, Ohio, 43210

    Peng Wang

    Not yet recruiting

  • Parkland Health and Hospital System

    Dallas, Texas, 75235

    214-648-4180

    Tian Zhang

    Not yet recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    214-648-4180

    Tian Zhang

    Recruiting

  • AdventHealth Medical Group - Porter

    Denver, Colorado, 80210

    303-715-7030

    Yousuf Gaffar

    Not yet recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Yusra Shao

    Recruiting

  • Brigitte Harris Cancer Pavilion

    Detroit, Michigan, 48202

    Muhammad Shahid

    Not yet recruiting

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

    732-390-7750

    Phillip Reid

    Recruiting

  • Endeavor Health

    Evanston, Illinois, 60201

    847-570-2112

    Ami Badami

    Not yet recruiting

  • Parkview Research Center at Parkview Regional Medical Center

    Fort Wayne, Indiana, 46845

    Kushal Naha

    Recruiting

  • James M Stockman Cancer Institute

    Frederick, Maryland, 21702

    Saro Sarkisian

    Not yet recruiting

  • Colorado West Healthcare System - Grand Valley Oncology

    Grand Junction, Colorado, 81505

    970-644-4460

    Jonathan King

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009

    Michael Glover

    Recruiting

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Tareq Salous

    Recruiting

  • Franciscan Health

    Indianapolis, Indiana, 46237

    Patrick Heckman

    Recruiting

  • Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine

    Irvine, California, 92612

    Nataliya Mar

    Recruiting

  • Lancaster General Hospital - Ann B Barshinger Cancer Institute

    Lancaster, Pennsylvania, 17601

    Matthew Brennan

    Not yet recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

    Ammar Yousif

    Recruiting

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

    Suspended

  • Accellacare of Duly

    Lisle, Illinois, 60532

    Brian Myre

    Not yet recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Anuradha kunthur

    Not yet recruiting

  • TRIO-US (Translational Research in Oncology-US)

    Los Angeles, California, 90024

    Brenda Williams

    Recruiting

  • UCLA Hematology/Oncology - Santa Monica

    Los Angeles, California, 90404

    Alexandra Drakaki

    Recruiting

  • Nova Oncology

    McAllen, Texas, 78504

    956-234-4400

    Raghad Muhsin Abdul Karim, MD

    Recruiting

  • Mary Bird Perkins Cancer Center - Metairie

    Metairie, Louisiana, 70002

    225-215-1185

    Victor Lin

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

    SMO Sarah Cannon Research Inst.

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Benjamin Garmezy

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Kathryn Beckermann

    Recruiting

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06510

    203-200-4822

    Joseph Kim

    Not yet recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

    504-842-3910

    Brian Halbert

    Not yet recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10032

    Alexander Wei

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    646-888-4737

    Gopakumar Iyer

    Recruiting

  • Weill Cornell Medical College

    New York, New York, 10065

    317-217-9178

    Rohit Jain

    Not yet recruiting

  • USO - Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Mark Fleming

    Recruiting

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center

    Orange, California, 92868

    Nataliya Mar

    Recruiting

  • AdventHealth Orlando

    Orlando, Florida, 32804

    407-303-2024

    Guru Sonpavde

    Not yet recruiting

  • AHN Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    412-325-5700

    Shifeng Mao

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Brendan Curti

    Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

    Brendan Curti

    Recruiting

  • Kaiser Permanente Interstate Medical Office Central

    Portland, Oregon, 97227

    503-249-3315

    Sandeep Mashru

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Ronald Ng

    Not yet recruiting

  • Wilmot Cancer Institute

    Rochester, New York, 14642

    585-275-4823

    Brendan Guercio

    Not yet recruiting

  • University of California Davis (UC Davis) Comprehensive Cancer Center

    Sacramento, California, 95817

    916-734-3772

    Mamta Parikh

    Recruiting

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158

    773-837-0783

    Vadim Koshkin

    Recruiting

  • Avera Cancer Institute- Research

    Sioux Falls, South Dakota, 57105

    Ryan Vaca

    Recruiting

  • Oncology Hematology Associates

    Springfield, Missouri, 65807

    417-882-4880

    Viran Holden

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63108

    Melissa Reimers

    Recruiting

  • US Oncology Research Network

    The Woodlands, Texas, 77380

    SMO Sarah Cannon Research Inst.

    Recruiting

  • Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer (TMPN)

    Torrance, California, 90505

    310-750-3300

    Hugo Hool

    Recruiting

  • The University of Arizona Cancer Center - North Campus

    Tucson, Arizona, 85719

    520-626-4703

    Alejandro Recio Boiles

    Recruiting

  • USO - Texas Oncology - Northeast Texas

    Tyler, Texas, 75702

    Donald Richards

    Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Nicholas Simon

    Not yet recruiting

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

    980-442-6410

    Earle Burgess

    Not yet recruiting

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

    508-856-3216

    Kriti Mittal

    Not yet recruiting

Other trials in United States

Spain26 sites, 26 recruiting

  • Hospital Infanta Cristina

    Badajoz, 06006

    924218040

    Marta Gonzalez Cordero

    Not yet recruiting

  • Institut Català d'Oncologia (ICO) - Badalona

    Badalona, 08916

    0034677254583

    Juan Martin Liberal

    Not yet recruiting

  • OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces

    Barakaldo, 48903

    Ricardo Fernández Rodríguez

    Not yet recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    932746000 x 4350

    Rafael Morales Barrera

    Recruiting

  • Hospital Clínic de Barcelona

    Barcelona, 08036

    34 932275402

    Oscar Reig Torras

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

    34935565638

    Jose Pablo Maroto Rey

    Not yet recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

    MARIA JOSE MENDEZ VIDAL

    Not yet recruiting

  • Hospital General Universitario de Elche

    Elche, 03202

    Federico Jose Vazquez Mazon

    Not yet recruiting

  • Institut Català d'Oncologia (ICO) - Girona

    Girona, 17007

    34972225834

    Nuria Sala Gonzalez

    Not yet recruiting

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals

    Hospitalet, 08907

    +34 932603261

    Irene Ortiz Rubio

    Not yet recruiting

  • Hospital Insular de Gran Canaria

    Las Palmas de Gran Canaria, 35016

    Alfonso Gómez de Liaño Lista

    Recruiting

  • Hospital La Princesa

    Madrid, 28006

    +34915202200

    Patricia Toquero Diez

    Not yet recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009

    34914265238

    Jose Arranz Arija

    Not yet recruiting

  • MD Anderson Cancer Center

    Madrid, 28033

    Lucrecia Ruiz

    Not yet recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

    (+34) 913368263

    Pablo Gajate Borau

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    913307545

    Javier Puente Vazquez

    Not yet recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    0034 91 390 83 39

    Daniel Castellano Gauna

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    917277516

    Alvaro Pinto Marin

    Not yet recruiting

  • H.R.U Málaga - Hospital General

    Málaga, 29011

    951308130

    Alvaro Montesa Pino

    Not yet recruiting

  • Complejo Hospitalario de Navarra

    Pamplona, 31009

    8.00 - 15.00

    Nuria Lainez Milagro

    Not yet recruiting

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28223

    +34914521987

    ELENA ALMAGRO CASADO

    Not yet recruiting

  • Hospital Universitari Sant Joan de Reus

    Reus, 43204

    Marc Grifoll Escoda

    Not yet recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

    607552230

    Ignacio Duran Martinez

    Not yet recruiting

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, 15706

    34981950512

    Urbano Anido Herranz

    Not yet recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

    34955013068

    Begona Perez Valderrama

    Recruiting

  • Hospital Arnau de Vilanova

    Valencia, 46015

    679370073

    Jose Garcia Sanchez

    Not yet recruiting

Other trials in Spain

China25 sites, 25 recruiting

  • Peking University First Hospital

    Beijing, 100034

    010-64008229

    Zhisong He

    Recruiting

  • Peking University Third Hospital

    Beijing, 100091

    Shudong Zhang

    Recruiting

  • Beijing Cancer hospital

    Beijing, 100142

    Jun Guo

    Recruiting

  • Beijing GoBroad Hospital

    Beijing, 102200

    Chuanliang Cui

    Recruiting

  • The First Hospital of Jilin University

    Changchun, 100012

    Ziling Liu

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, 410008

    0731-84327918

    minfeng chen

    Recruiting

  • Hunan Cancer Hospital

    Changsha, 410013

    Shusuan JIANG

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, 610066

    Peng Zhang

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016

    023-89012012

    Weiyang He

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, 400030

    Fang Yuan

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510230

    13719007083

    Yongda Liu

    Recruiting

  • Zhujiang Hospital

    Guangzhou, 510280

    Manming Cao

    Recruiting

  • Sun Yat-Sen University Cancer Centre

    Guangzhou, 511400

    020-87343864

    Yanxia Shi

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310014

    15158885167

    xiaolong Qi

    Recruiting

  • Sir Run Run Shaw Hospital

    Hangzhou, 310016

    Da Li

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

    Jinchao Chen

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

    0451-86298104

    Hui Chen

    Recruiting

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210000

    Hongqian Guo

    Recruiting

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, 530200

    15877183968

    Yong Tang

    Recruiting

  • Ningbo First Hospital

    Ningbo, 315010

    15958800971

    Qi Ma

    Recruiting

  • Renji Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, 200000

    862168383543

    Wei Xue

    Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, 200040

    Haowen Jiang

    Recruiting

  • Shanghai Tenth People's Hospital

    Shanghai, 200072

    021-66301719

    Xudong Yao

    Recruiting

  • The Second Hospital of Tianjin Medical University

    Tianjin, 300211

    Hailong Hu

    Recruiting

  • Tongji Hospital Tongji Medical,Science & Technology

    Wuhan, 430030

    027-83363434

    Shaogang Wang

    Recruiting

Other trials in China

Germany25 sites, 25 recruiting

  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526

    0049 33631 73466

    Tobias Klatte

    Not yet recruiting

  • Evangelisches Krankenhaus Bielefeld - Johannesstift

    Bielefeld, 33611

    052177275750

    Florian Weissinger

    Not yet recruiting

  • Johanniter-Krankenhaus

    Bonn, 53113

    00492285432168

    Carsten Ohlmann

    Not yet recruiting

  • Studienzentrum Bayenthal Urologische Partnerschaft Köln

    Cologne, 50968

    0049221362025

    Jorg Klier

    Not yet recruiting

  • Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

    Dresden, 01307

    00493514584425

    Severine Banek

    Not yet recruiting

  • Urologicum Duisburg Fachärztesozietät - Walsum

    Duisburg, 47169

    +49 203 5003040

    Eva Hellmis

    Not yet recruiting

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

    492118119353

    Guenter Niegisch

    Not yet recruiting

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

    +49 (0)9131 8223122

    Peter Goebell

    Not yet recruiting

  • Universitaetsklinikum Essen

    Essen, 45122

    +492017232637

    Viktor Gruenwald

    Not yet recruiting

  • Krankenhaus Nordwest GmbH

    Frankfurt, 60488

    496976013917

    Inga Peters

    Not yet recruiting

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

    Philippe-Fabian Pohlmann

    Not yet recruiting

  • Universitätsmedizin Greifswald

    Greifswald, 17489

    00493834865985

    Cindy Roennau

    Not yet recruiting

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    040-7410-57673

    Gunhild Von Amsberg

    Not yet recruiting

  • NCT

    Heidelberg, 69120

    +4962215634619

    Maximilian Jenzer

    Not yet recruiting

  • Universitaetsklinikum des Saarlandes

    Homburg, 66424

    Johannes Linxweiler

    Not yet recruiting

  • InVO Institut für Versorgungsforschung in der Onkologie

    Koblenz, 56068

    +49261921569325

    Christoph Lutz

    Not yet recruiting

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538

    045150043691

    Axel Merseburger

    Not yet recruiting

  • Klinikum Rechts Der Isar Der Technischen Universität München

    Munich, 81675

    498941402522

    Margitta Retz

    Not yet recruiting

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    Münster, 48149

    Martin Boegemann

    Not yet recruiting

  • Klinikum Nürnberg Nord

    Nuremberg, 90419

    + 49 911 398 3085

    Marinela Augustin

    Not yet recruiting

  • Studienpraxis Urologie

    Nürtingen, 72622

    4915201622246

    Tilman Todenhöfer

    Not yet recruiting

  • Universitätsmedizin Rostock

    Rostock, 18057

    +49 381 494 7801

    Angelika Borkowetz

    Not yet recruiting

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

    Eva Erne

    Not yet recruiting

  • Universitaetsklinikum Ulm

    Ulm, 89081

    4973150058036

    Friedemann Zengerling

    Not yet recruiting

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080

    Anna Seitz

    Not yet recruiting

Other trials in Germany

Japan20 sites, 20 recruiting

  • National Cancer Center Hospital

    Chūōku, 104-0045

    81120023812

    Tatsunori Shimoi

    Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582

    81120023812

    Takashi Matsumoto

    Recruiting

  • Hirosaki University Hospital

    Hirosaki, 036-8563

    81120023812

    Shingo Hatakeyama

    Recruiting

  • Kanazawa University Hospital

    Kanazawa, 920-8641

    81120023812

    Hiroshi Yaegashi

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

    81120023812

    Nobuaki Matsubara

    Recruiting

  • St. Marianna University Hospital

    Kawasaki, 216-8511

    81120023812

    Eiji Kikuchi

    Recruiting

  • Kagawa University Hospital

    Kita-ku, 761-0701

    81120023812

    Rikiya Taoka

    Recruiting

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047

    81120023812

    Toshinari Yamasaki

    Recruiting

  • The Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550

    81120023812

    Yuji Miura

    Recruiting

  • Kyoto University Hospital

    Kyoto, 606-8507

    81120023812

    Akihiro Hamada

    Recruiting

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, 791-0280

    81120023812

    Katsuyoshi Hashine

    Recruiting

  • Aichi Cancer Center Hospital

    Nagoya, 464-8681

    81120023812

    Hiromichi Ebi

    Recruiting

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520

    81120023812

    Tsutomu Anraku

    Recruiting

  • Osaka International Cancer Institute

    Osaka, 541-8567

    81120023812

    Masashi Nakayama

    Recruiting

  • Gunma Prefectural Cancer Center

    Otashi, 373-8550

    81120023812

    Masaru Hasumi

    Recruiting

  • Hokkaido University Hospital

    Sapporo, 060-8648

    81120023812

    Haruka Miyata

    Recruiting

  • Tohoku University Hospital

    Sendai, 980-8574

    81120023812

    Takuma Sato

    Recruiting

  • Iwate Medical University Hospital

    Shiwa-gun Yahaba-cho, 028-3695

    81120023812

    Wataru Obara

    Recruiting

  • Tokushima University Hospital

    Tokushima, 770-8503

    81120023812

    junya furukawa

    Recruiting

  • Tsukuba University Hospital

    Tsukuba, 305-8576

    81120023812

    Yoshiyuki Nagumo

    Recruiting

Other trials in Japan

Brazil12 sites, 12 recruiting

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, 14784400

    Rodrigo Ferreira

    Not yet recruiting

  • CPAM - Centro de Pesquisas da Amazônia

    Belém, 66063-495

    5591999809897

    Bruno Fernandes

    Not yet recruiting

  • Hospital Tacchini

    Bento Gonçalves, 95700-084

    ANDRE REIRIZ

    Not yet recruiting

  • IOP Pesquisa

    Curitiba, 82305-100

    Ronald Kool

    Not yet recruiting

  • Hospital de Cancer de Londrina

    Londrina, 86015-520

    +55 43 3379-2771

    Mariana Kiara

    Not yet recruiting

  • Liga Norte Riograndense Contra o Câncer

    Natal, 59062-000

    +5584991425228

    Andrea Gomes

    Not yet recruiting

  • Hospital Nossa Senhora da Conceição

    Porto Alegre, 91350-200

    +55 51 35160954

    Gustavo Alves

    Not yet recruiting

  • Instituto de Oncologia Saint Gallen

    Santa Cruz do Sul, 96830-180

    5551991898942

    Bianca Correa Tabajara Weiss

    Not yet recruiting

  • Centro de Oncologia - CEON+ - Unidade São Caetano do Sul

    São Caetano do Sul, 09541-270

    Suelen Martins

    Not yet recruiting

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo, 01246-000

    55 11 3893-2709

    Jose Mauricio Mota

    Not yet recruiting

  • Hospital BP

    São Paulo, 01321-001

    Fabio Schutz

    Not yet recruiting

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01327-001

    1135490665

    Ariel Kann

    Not yet recruiting

Other trials in Brazil

France12 sites, 12 recruiting

  • Institut de Cancérologie de l'Ouest

    Angers, 49055

    33241352700

    Sophie Abadie-Lacourtoisie

    Not yet recruiting

  • CHU de Bordeaux Hop St ANDRE

    Bordeaux, 33075

    +33556794708

    Marine Gross-Goupil

    Recruiting

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, 33076

    Diego Teyssonneau

    Not yet recruiting

  • CHRU de Brest

    Brest, 29609

    Benjamin Auberger

    Not yet recruiting

  • Centre François Baclesse

    Caen, 14076

    Florence Joly-Lobbedez

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  • Centre Oscar Lambret

    Lille, 59020

    0033 (0)320009757

    Yaovi AMELA

    Not yet recruiting

  • Centre Leon Berard

    Lyon Cedex08, 69373

    33478782643

    Aude Flechon

    Recruiting

  • Institut Paoli-Calmettes

    Marseille, 13273

    Gwenaelle Gravis

    Not yet recruiting

  • Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire Carém -T

    Nîmes, 30029

    Leticia Aptecar

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  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

    33478864324

    Denis Maillet

    Not yet recruiting

  • Oncopole Claudius Regaud

    Toulouse, 31059

    Damien POUESSEL

    Not yet recruiting

  • Gustave Roussy

    Villejuif, 94800

    33142115276

    Yohann Loriot

    Recruiting

Other trials in France

Poland12 sites, 12 recruiting

  • IN VIVO

    Bydgoszcz, 85-048

    48888455614

    Anna Krause

    Not yet recruiting

  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie

    Koszalin, 75-581

    48502204953

    Mariusz Kwiatkowski

    Not yet recruiting

  • Pratia MCM Krakow

    Krakow, 30-727

    48 505 169 040

    Anna Drosik Kwasniewska

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  • AIDPORT Sp. z o.o.

    Skórzewo, 60-185

    Piotr Tomczak

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  • GYNCENTRUM Szpital

    Sosnowiec, 41-208

    Sylwia Szablowska-Siwik

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  • Luxmed Onkologia sp. z o. o.

    Warsaw, 01-748

    Pawel Morawski

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  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

    Warsaw, 02-781

    48225462433

    Pawel Wiechno

    Not yet recruiting

  • WSD MEDI

    Warsaw, 02-786

    Anna Wasko Grabowska

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  • Medical Concierge Centrum Medyczne

    Warsaw, 02-798

    602300992

    Piotr Radziszewski

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  • Szpital Grochowski im. dr med. Rafała Masztaka SPZOZ

    Warsaw, 04-073

    48 22 5152 591

    Iwona Skoneczna

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  • Wojskowy Instytut Medyczny Państwowy Instytut Badawczy

    Warsaw, 04-141

    Szymon Borowiec

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  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wrocaw, 50-556

    Anna Kolodziej

    Not yet recruiting

Other trials in Poland

Taiwan11 sites, 11 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

    Wen-Jeng Wu

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  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, 83301

    886-972919696

    Yu-Li Su

    Recruiting

  • China Medical University Hospital

    Taichung, 404332

    Chao-Hsiang Chang

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407

    Jian-Ri Li

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  • National Cheng Kung University Hospital

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    0980971870

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  • Chi Mei Medical Center

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    Tainan, 73657

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  • National Taiwan University Hospital

    Taipei, 10002

    Yu-Chieh Tsai

    Recruiting

  • National Taiwan University Cancer Center (NTUCC)

    Taipei, 106

    Ying-Chun Shen

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    886228757519-323

    Yi-Hsiu Huang

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  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

    886-3-3281200

    See-Tong Pang

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Other trials in Taiwan

Turkey (Türkiye)11 sites, 11 recruiting

  • Adana Medical Park Seyhan Hastanesi

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    905325005269

    Ali Besen

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  • Sakarya University School of Medicine

    Adapazarı, 54100

    +90 5054785576

    Ilhan Hacibekiroglu

    Not yet recruiting

  • Ankara University Health Practice and Research Hospitals

    Ankara, 06100

    00903125957321

    Yuksel Urun

    Not yet recruiting

  • Ankara Bilkent Şehir Hastanesi

    Ankara, 06800

    905555306271

    Mehmet Ali Nahit Sendur

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  • Antalya Egitim ve Arastırma Hastanesi

    Antalya, 07100

    905336488217

    Derya KIVRAK SALIM

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  • Dicle Üniversitesi

    Diyarbakır, 21200

    90 5337677131

    Muhammet kaplan

    Not yet recruiting

  • Trakya University

    Edirne, 22030

    90 5334364678

    Muhammet Hacioglu

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  • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

    Gaziantep, 27310

    05065118207

    tulay kus

    Not yet recruiting

  • Marmara Universitesi Pendik Egitim Arastirma Hastanesi

    Istanbul, 34899

    905433389339

    Murat Sari

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  • zmir Katip Çelebi Üniversitesi Atatürk Eitim Ve Aratrma Hastanesi

    Izmir, 35360

    905324078648

    Ahmet Alacacioglu

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  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Kadıköy, 34722

    Mahmut Gumus

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Other trials in Turkey (Türkiye)

South Korea10 sites, 10 recruiting

  • National Cancer Center

    Goyang-si, 10408

    Ho Kyung Seo

    Recruiting

  • Chungnam national university hospital

    Junggu, 35015

    Hyo Jin Lee

    Recruiting

  • Gachon University Gil Medical Center

    Namdong-gu, 21565

    Joo-Hwan Park

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 13620

    820317877842

    Eun Hee Jung

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    82-2-2072-4035

    Miso Kim

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    82222288138

    Sang Joon Shin

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  • Asan Medical Center

    Seoul, 05505

    82-2-3010-3266

    Inkeun Park

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  • Samsung Medical Center

    Seoul, 06351

    82-2-3410-3459

    Se Hoon Park

    Recruiting

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul, 06591

    82-10-9056-6116

    In-Ho Kim

    Recruiting

  • Ewha Womans University Mokdong Hospital

    Seoul, 07985

    Jungmin Jo

    Recruiting

Other trials in South Korea

Australia9 sites, 9 recruiting

  • Box Hill Hospital

    Box Hill, 3128

    Iris Tung

    Recruiting

  • Mater Misericordiae Limited

    Brisbane, 4101

    Niara Oliveira

    Recruiting

  • GenesisCare - Campbelltown

    Campbelltown, 2560

    Felicia Roncolato

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  • Austin Health

    Heidelberg, 3084

    +61420381848

    Andrew Weickhardt

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  • Macquarie University

    Macquarie University, 2109

    0402856430

    Alison Zhang

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  • Sir Charles Gairdner Hospital

    Perth, 6009

    Rajiv Shinde

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  • Prince of Wales Hospital

    Randwick, 2031

    Elizabeth Hovey

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    St Albans, 3021

    412139261

    Shirley Wong

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  • Calvary Mater Newcastle

    Waratah, 2298

    Lucy Corke

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Other trials in Australia

Italy8 sites, 8 recruiting

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    +39 0805555391

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    0390223903028

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    +390226435789

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    +393404166268

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  • Istituto Oncologico Veneto IRCCS

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    Pisa, 56126

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  • Fondazione Policlinico Universitario Agostino Gemelli

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    390630154838

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Other trials in Italy

United Kingdom7 sites, 7 recruiting

  • Huddersfield Royal Infirmary

    Huddersfield, HD3 3EA

    Ursula Hofmann

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    London, EC1A 7BE

    02078828494

    Thomas Powles

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  • University College London Hospital

    London, NW1 2PG

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    London, SM2 5PT

    +44 (0) 2086613529

    Robert Huddart

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  • Royal Marsden Hospital (Chelsea)

    London, SW3 6JJ

    +44 (0) 2086613529

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    01614468409

    Yee Pei Song

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    Sheffield, S10 2SJ

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Other trials in United Kingdom

Czechia6 sites, 6 recruiting

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    420 543 132 216

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    Olomouc, 779 00

    +420 588 444 717

    Hana Studentova

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  • Fakultni nemocnice Motol

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    420734236410

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Other trials in Czechia

Denmark5 sites, 5 recruiting

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Other trials in Denmark

Hungary5 sites, 5 recruiting

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Other trials in Netherlands

About this study

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

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.

Being tested
Vepugratinib, Placebo, EV, Pembrolizumab
Keywords
FGFR3, Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma
Medical subject headings
Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VepugratinibDrug

    Administered orally

  • PlaceboOther

    Administered orally

  • EVDrug

    Administered by IV infusion

  • PembrolizumabDrug

    Administered by IV infusion

Study groups in NCT07218380
Study groupRoleWhat they receive
Vepugratinib + EV + Pembrolizumab (Safety Lead In)ExperimentalVepugratinib administered orally with EV + pembrolizumab administered IV
Receives: Drug: Vepugratinib; Drug: EV; Drug: Pembrolizumab
Vepugratinib + Enfortumab Vedotin (EV) + PembrolizumabExperimentalVepugratinib administered orally, and EV + pembrolizumab administered by intravenous (IV) infusion.
Receives: Drug: Vepugratinib; Drug: EV; Drug: Pembrolizumab
Placebo + EV + PembrolizumabPlacebo comparatorPlacebo administered orally, and EV + pembrolizumab administered by IV infusion.
Receives: Other: Placebo; Drug: EV; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse events related to vepugratinib in combination with EV and pembrolizumab

    Measured: From baseline up to 90 months

  2. Safety Lead-in: Overall Response Rate (ORR)

    ORR by Investigator Assessment.

    Measured: From baseline up to 90 months

  3. Progression-free Survival (PFS)

    PFS by blinded independent committee review (BICR).

    Measured: Baseline to Study Completion (estimated as 6 years)

Secondary outcomes (11)

  1. Safety Lead-in: Disease Control Rate (DCR)

    DCR by investigator assessment.

    Measured: From baseline up to the end of Cycle 2 (each Cycle is 21 days)

  2. Safety Lead-in: Time to Response (TTR)

    TTR by investigator assessment.

    Measured: From baseline up to 90 months

  3. Overall Survival (OS)

    Measured: Baseline to Study Completion (estimated as 6 years)

  4. Objective Response Rate (ORR) by BICR

    Measured: Baseline to Study Completion (estimated as 6 years)

  5. Duration of Response (DoR)

    DOR by BICR.

    Measured: Baseline to Study Completion (estimated as 6 years)

  6. Progression-free Survival (PFS)

    PFS by investigator assessment.

    Measured: Baseline to Study Completion (estimated as 6 years)

  7. Objective Response Rate (ORR)

    Percentage of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)ORR by investigator assessment

    Measured: Baseline to Study Completion (estimated as 6 years)

  8. Duration of Response (DOR)

    DOR by investigator assessment.

    Measured: Baseline to Study Completion (estimated as 6 years)

  9. Progression-free Survival 2 (PFS2)

    PFS2 by investigator assessment.

    Measured: Baseline to Study Completion (estimated as 6 years)

  10. Plasma Concentrations of Vepugratinib

    PK samples are to be drawn every odd cycle while participant on study.

    Measured: Cycle 1 Day 1 to Study completion (estimated as 90 months)

  11. Change from Baseline in Global Health Status/Quality of Life (QOL) and Physical Function Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    The EORTC QLQ-C30 is a validated self-reported general cancer questionnaire consisting of 30 items with a recall of the past 7 days. Response options range from 1) "very poor" to 7) "excellent." Higher scores represent better overall HRQoL.

    Measured: Baseline to Study Completion (estimated as 6 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2025
  2. Study start12 Dec 2025
  3. Primary completionOct 2029 (estimated)
  4. Study completionMay 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07218380
Sponsor's protocol ID
27333
Other IDs
J4G-MC-JZVD, 2025-522855-25-00, 2025
Acronym
FORAGER-2
Status last verified
Oct 2026
First submitted
9 Oct 2025
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vepugratinib, EV and Pembrolizumab in people with Carcinoma, Transitional Cell and Urinary Bladder Neoplasms, run by Eli Lilly and Company at 276 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 276 sites in United States, Spain, China, Germany, Japan and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events related to vepugratinib in combination with EV and pembrolizumab (time frame: From baseline up to 90 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07218380.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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