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Recruiting Phase 3 2025-522855-25-00

J4G-MC-JZVD - 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.

Phase 3 – large-scale trial before approval
Conditions: Carcinoma Transitional Cell Urinary Bladder Neoplasms Neoplasm Metastasis

Sponsor: Eli Lilly & Co.

trial.available_in: БГ
Overview
Trial status: Authorised Safety Lead-in:Safety and Tolerability of vepugratinib in combination with EV and pembrolizumab, Safety Lead-in:Overall Response Rate (ORR), Progression-free Survival (PFS) by Blinded Independent Central Review (BICR)
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 117 participants
Interventions
PEMBROLIZUMAB
Drug
Placebo to match ly
Drug
ENFORTUMAB VEDOTIN
Drug
Locations 7
Czech Republic (1)
Denmark (1)
Germany (1)
Hungary (1)
Italy (1)
Netherlands (1)
Poland (1)
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
20.04.2026
Registry ID
2025-522855-25-00
Source
euclinicaltrials.eu
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