NCT07218380

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

FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. Vepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab. Study participation could last up to approximately 6 years.

Conditions

• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Vepugratinib	Administered orally
OTHER	Placebo	Administered orally
DRUG	EV	Administered by IV infusion
DRUG	Pembrolizumab	Administered by IV infusion

Timeline

• Start date: 2025-12-12
• Primary completion: 2029-10-01
• Completion: 2033-05-01
• First posted: 2025-10-20
• Last updated: 2026-04-17

Locations

281 sites across 19 countries: United States, Australia, Brazil, Canada, China, Czechia, Denmark, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study