A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
Sponsor: Eli Lilly and Company
ClinicalTrials ID:NCT07218380
This study evaluates the safety and efficacy of vepugratinib versus placebo, both combined with enfortumab vedotin and pembrolizumab, in patients with advanced or metastatic urothelial cancer. Eligible participants must have FGFR3 genetic alterations, measurable disease, and an ECOG status of 0-2. Vepugratinib and placebo are administered orally, while other drugs are given via IV infusion.
Patient Parameters
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Program Overview
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 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Clearview Cancer Institute | 35805 | Huntsville | Alabama |
| The University of Arizona Cancer Center - North Campus | 85719 | Tucson | Arizona |
| TRIO-US (Translational Research in Oncology-US) | 90024 | Los Angeles | California |
| UCLA Hematology/Oncology - Santa Monica | 90404 | Los Angeles | California |
| UCSF Medical Center at Mission Bay | 94158 | San Francisco | California |
| Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer (TMPN) | 90505 | Torrance | California |
| AdventHealth Medical Group - Porter | 80210 | Denver | Colorado |
| Colorado West Healthcare System - Grand Valley Oncology | 81505 | Grand Junction | Colorado |
| AdventHealth Celebration | 34747 | Celebration | Florida |
| St. Luke's Cancer Institute: Boise | 83712 | Boise | Idaho |
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