J4G-MC-JZVD
Research type
Research Study
Full title
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.
IRAS ID
1013024
Contact name
Lena Mikulski
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
Short title of this project: A Study Investigating Vepugratinib Combined with Enfortumab Vedotin and Pembrolizumab in Adults with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma [FORAGER-2]
The purpose of this study is to evaluate the efficacy and safety of vepugratinib administered in combination with existing standard of care EV + pembrolizumab compared to EV + pembrolizumab alone in adults with previously untreated locally advanced or metastatic urothelial carcinoma with an FGFR3 genetic alteration.This study will consist of a
• screening period
• treatment period, and
• posttreatment follow-up period
Participants may receive 1 cycle of standard-of-care EV + pembrolizumab before randomization if immediate treatment is clinically indicated. Each treatment cycle is 21 days (±3 days) long and is anchored to the first day of the previous cycle. The study will enroll approximately 450 participants who will be randomly assigned to the study intervention. Study participants will be excluded based on conditions that could interfere with study assessments or increase a participant’s risk of experiencing side effects during the study. Participants who are still on study intervention at the time of study completion may continue to receive study intervention if they are experiencing clinical benefit and no undue risks.
The UK will be participating in the Safety lead-in which is an open-label, single-arm part of this study.
The estimated enrolment duration for Safety lead-in is 4 months, Randomisation portion is 28 months.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
25/EE/0278
Date of REC Opinion
21 Jan 2026
REC opinion
Further Information Favourable Opinion