Status:
RECRUITING
A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
Lead Sponsor:
Eli Lilly and Company
Conditions:
Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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. Vepugrati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2033
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT07218380
Start Date
December 12 2025
End Date
May 1 2033
Last Update
December 18 2025
Active Locations (271)
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1
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
2
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States, 85719
3
TRIO-US (Translational Research in Oncology-US)
Los Angeles, California, United States, 90024
4
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States, 90404