Tests vepugratinib with standard drugs for bladder cancer that has spread
Tests vepugratinib with other cancer drugs in adults with advanced bladder cancer.
Plain-language title generated from the registry record
Registry title: A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
Key facts
- Where
- Goyang-si, Junggu, Namdong-gu, Seongnam, and Seoul, South KoreaSee the 10 sites
- Phase
- Phase 3
Where in South Korea
- National Cancer CenterGoyang-si, South KoreaTaking people
- Chungnam national university hospitalJunggu, South KoreaTaking people
- Gachon University Gil Medical CenterNamdong-gu, South KoreaTaking people
- Seoul National University Bundang HospitalSeongnam, South KoreaTaking people
- Asan Medical CenterSeoul, South KoreaTaking people
- Ewha Womans University Mokdong HospitalSeoul, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- Seoul National University HospitalSeoul, South KoreaTaking people
- Severance Hospital, Yonsei University Health SystemSeoul, South KoreaTaking people
- The Catholic Univ. of Korea Seoul St. Mary's HospitalSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07218380EU 2025-522855-25-00
- Record updated
- 7 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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 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; Have ongoing sensory or motor neuropathy of Grade 2 or higher.