RecruitingCarcinoma, Transitional CellUrinary Bladder NeoplasmsNeoplasm Metastasis

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

Eligible age

18+ yrs

Accepts

All genders

Locations

28 states

Healthy volunteers

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About this study

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.

Sponsor: Eli Lilly and Company

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.