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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• Clearview Cancer Institute, Huntsville, Alabama, United States
• 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

+ 275 more sites.

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07218380.