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Clinical Trials in the UK / NCT07218380
Recruiting Phase 3

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

NCT07218380 · tracked via the Priya Life Science UK tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2025-12-12
Last updated
2026-08-21

Condition(s) studied

Carcinoma, Transitional CellUrinary Bladder NeoplasmsNeoplasm Metastasis

Investigational drug(s) / intervention(s)

VepugratinibPlaceboEVPembrolizumab

Vepugratinib: Administered orally

Placebo: Administered orally

EV: Administered by IV infusion

Pembrolizumab: Administered by IV infusion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (290)

FacilityCityRegionStatus
Clearview Cancer Institute Huntsville Alabama Recruiting
The University of Arizona Cancer Center - North Campus Tucson Arizona Recruiting
University of Arkansas for Medical Sciences Little Rock Arkansas Not Yet Recruiting
Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine Irvine California Recruiting
TRIO-US (Translational Research in Oncology-US) Los Angeles California Recruiting
UCLA Hematology/Oncology - Santa Monica Los Angeles California Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center Orange California Recruiting
University of California Davis (UC Davis) Comprehensive Cancer Center Sacramento California Not Yet Recruiting
UCSF Medical Center at Mission Bay San Francisco California Recruiting
Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer (TMPN) Torrance California Recruiting
AdventHealth Medical Group - Porter Denver Colorado Not Yet Recruiting
Colorado West Healthcare System - Grand Valley Oncology Grand Junction Colorado Recruiting
Yale-New Haven Hospital New Haven Connecticut Not Yet Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia Not Yet Recruiting
AdventHealth Orlando Orlando Florida Not Yet Recruiting
St. Luke's Cancer Institute: Boise Boise Idaho Not Yet Recruiting
University of Illinois at Chicago Chicago Illinois Recruiting
University of Chicago Medical Center Chicago Illinois Not Yet Recruiting
Endeavor Health Evanston Illinois Not Yet Recruiting
Accellacare of Duly Lisle Illinois Not Yet Recruiting
Parkview Research Center at Parkview Regional Medical Center Fort Wayne Indiana Recruiting
Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana Recruiting
Franciscan Health Indianapolis Indiana Recruiting
University of Kentucky Chandler Medical Center Lexington Kentucky Suspended
Mary Bird Perkins Cancer Center Baton Rouge Louisiana Recruiting
Mary Bird Perkins Cancer Center - Metairie Metairie Louisiana Not Yet Recruiting
Ochsner Clinic Foundation New Orleans Louisiana Not Yet Recruiting
Johns Hopkins Hospital Baltimore Maryland Recruiting
James M Stockman Cancer Institute Frederick Maryland Not Yet Recruiting
Massachusetts General Hospital Boston Massachusetts Not Yet Recruiting
University of Massachusetts Medical School Worcester Massachusetts Not Yet Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
Brigitte Harris Cancer Pavilion Detroit Michigan Not Yet Recruiting
Oncology Hematology Associates Springfield Missouri Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Comprehensive Cancer Centers of Nevada Las Vegas Nevada Recruiting
Astera Cancer Care East Brunswick New Jersey Recruiting
Columbia University Irving Medical Center New York New York Not Yet Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Weill Cornell Medical College New York New York Not Yet Recruiting

+ 250 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Eli Lilly and Company trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07218380 on ClinicalTrials.gov ↗ ← All trials in the UK