Home › Urothelial (Transitional Cell) Carcinoma › NCT07218380
A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
RecruitingPhase 3
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
About the study
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.
What is being tested
- Vepugratinib (drug)
- Placebo (other)
- EV (drug)
- Pembrolizumab (drug)
Sponsor: Eli Lilly and Company · Participants: 450 · Started: Dec 12, 2025
Contact the study team
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · Phone: 1-317-615-4559
Official record on ClinicalTrials.gov — NCT07218380
Locations in the U.S.
| Arizona | The University of Arizona Cancer Center - North Campus, Tucson |
| Arkansas | University of Arkansas for Medical Sciences, Little Rock (Not yet recruiting) |
| California | Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine, Irvine TRIO-US (Translational Research in Oncology-US), Los Angeles UCLA Hematology/Oncology - Santa Monica, Los Angeles University of California, Irvine (UCI) Health - UC Irvine Medical Center, Orange University of California Davis (UC Davis) Comprehensive Cancer Center, Sacramento (Not yet recruiting) UCSF Medical Center at Mission Bay, San Francisco Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer (TMPN), Torrance |
| Colorado | AdventHealth Medical Group - Porter, Denver (Not yet recruiting) Colorado West Healthcare System - Grand Valley Oncology, Grand Junction |
| Connecticut | Yale-New Haven Hospital, New Haven (Not yet recruiting) |
| District of Columbia | MedStar Washington Hospital Center, Washington D.C. (Not yet recruiting) |
| Florida | AdventHealth Orlando, Orlando (Not yet recruiting) |
| Idaho | St. Luke's Cancer Institute: Boise, Boise (Not yet recruiting) |
| Illinois | University of Chicago Medical Center, Chicago (Not yet recruiting) University of Illinois at Chicago, Chicago Endeavor Health, Evanston (Not yet recruiting) Accellacare of Duly, Lisle (Not yet recruiting) |
| Indiana | Parkview Research Center at Parkview Regional Medical Center, Fort Wayne Franciscan Health, Indianapolis Indiana University Melvin and Bren Simon Cancer Center, Indianapolis |
| Louisiana | Mary Bird Perkins Cancer Center, Baton Rouge Mary Bird Perkins Cancer Center - Metairie, Metairie (Not yet recruiting) Ochsner Clinic Foundation, New Orleans (Not yet recruiting) |
| Maryland | Johns Hopkins Hospital, Baltimore James M Stockman Cancer Institute, Frederick (Not yet recruiting) |
| Massachusetts | Massachusetts General Hospital, Boston (Not yet recruiting) University of Massachusetts Medical School, Worcester (Not yet recruiting) |
| Michigan | Karmanos Cancer Institute, Detroit |
| Missouri | Oncology Hematology Associates, Springfield Washington University School of Medicine, St Louis |
| Nevada | Comprehensive Cancer Centers of Nevada, Las Vegas |
| New Jersey | Astera Cancer Care, East Brunswick |
| New York | Columbia University Irving Medical Center, New York Memorial Sloan Kettering Cancer Center, New York Weill Cornell Medical College, New York (Not yet recruiting) Wilmot Cancer Institute, Rochester (Not yet recruiting) |
| North Carolina | Levine Cancer Institute, Charlotte (Not yet recruiting) Oncology Specialists of Charlotte, Charlotte Wake Forest Baptist Health, Winston-Salem (Not yet recruiting) |
| Ohio | University of Cincinnati Medical Center, Cincinnati (Not yet recruiting) The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T, Columbus (Not yet recruiting) |
| Oregon | Kaiser Permanente Interstate Medical Office Central, Portland Oregon Health and Science University, Portland (Not yet recruiting) Providence Portland Medical Center, Portland Providence St. Vincent Medical Center, Portland |
| Pennsylvania | Lancaster General Hospital - Ann B Barshinger Cancer Institute, Lancaster (Not yet recruiting) AHN Allegheny General Hospital, Pittsburgh |
| South Dakota | Avera Cancer Institute- Research, Sioux Falls |
| Tennessee | SCRI Oncology Partners, Nashville Sarah Cannon Research Institute, Nashville Tennessee Oncology, Nashville |
| Texas | USO-Texas Oncology-Central/South Texas, Austin World Research Link, Baytown Parkland Health and Hospital System, Dallas (Not yet recruiting) UT Southwestern Medical Center, Dallas University of Texas MD Anderson Cancer Center, Houston Nova Oncology, McAllen US Oncology Research Network, The Woodlands USO - Texas Oncology - Northeast Texas, Tyler |
| Virginia | USO - Virginia Oncology Associates, Norfolk |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.