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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT07218380

Run by

Eli Lilly and Company

People needed

450

Starts

2025-12-12

Expected to finish

2033-05-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Providence Portland Medical Center — Portland, Oregon, United States (enrolling)
• Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Oncology Specialists of Charlotte — Charlotte, North Carolina, United States (enrolling)
• Kaiser Permanente Interstate Medical Office Central — Portland, Oregon, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• Oncology Hematology Associates — Springfield, Missouri, United States (enrolling)
• Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer (TMPN) — Torrance, California, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Providence St. Vincent Medical Center — Portland, Oregon, United States (enrolling)
• UCLA Hematology/Oncology - Santa Monica — Los Angeles, California, United States (enrolling)
• Avera Cancer Institute- Research — Sioux Falls, South Dakota, United States (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
• Clearview Cancer Institute — Huntsville, Alabama, United States (enrolling)
• University of Illinois at Chicago — Chicago, Illinois, United States (enrolling)
• UCSF Medical Center at Mission Bay — San Francisco, California, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• Parkview Research Center at Parkview Regional Medical Center — Fort Wayne, Indiana, United States (enrolling)
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States (enrolling)
• Franciscan Health — Indianapolis, Indiana, United States (enrolling)
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States (enrolling)
• Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana, United States (enrolling)
• Colorado West Healthcare System - Grand Valley Oncology — Grand Junction, Colorado, United States (enrolling)
• USO-Texas Oncology-Central/South Texas — Austin, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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