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

RecruitingPhase 3

Sponsor: Eli Lilly and Company

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

Interventions: Vepugratinib, Placebo, EV, Pembrolizumab

Countries: United States, Australia, Brazil, Canada, China, Czechia, Denmark, France

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 (290)

Huntsville, Alabama, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Irvine, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Orange, California, United States
Sacramento, California, United States
San Francisco, California, United States
Torrance, California, United States
Denver, Colorado, United States
Grand Junction, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Orlando, Florida, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Lisle, Illinois, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Lexington, Kentucky, United States
Baton Rouge, Louisiana, United States
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Frederick, Maryland, United States
Boston, Massachusetts, United States
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