A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Vepugratinib
- Placebo
- EV
- Pembrolizumab
Treatment groups
450 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov