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
- Beijing, Changchun, Changsha, Chengdu, Chongqing, Guangzhou, Hangzhou, Harbin, Nanjing, Nanning, Ningbo, Shanghai, Tianjin, and Wuhan, ChinaSee the 25 sites
- Phase
- Phase 3
Where in China
- Beijing Cancer HospitalBeijing, ChinaTaking people
- Beijing GoBroad HospitalBeijing, ChinaTaking people
- Peking University First HospitalBeijing, ChinaTaking people
- Peking University Third HospitalBeijing, ChinaTaking people
- The First Hospital of Jilin UniversityChangchun, ChinaTaking people
- Hunan Cancer HospitalChangsha, ChinaTaking people
- Xiangya Hospital Central South UniversityChangsha, ChinaTaking people
- West China Hospital，Sichuan UniversityChengdu, ChinaTaking people
- Chongqing University Cancer HospitalChongqing, ChinaTaking people
- The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
- Sun Yat-Sen University Cancer CentreGuangzhou, ChinaTaking people
- The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaTaking people
- Zhujiang HospitalGuangzhou, ChinaTaking people
- Sir Run Run Shaw HospitalHangzhou, ChinaTaking people
- Zhejiang Cancer HospitalHangzhou, ChinaTaking people
- Zhejiang Provincial People's HospitalHangzhou, ChinaTaking people
- Harbin Medical University Cancer HospitalHarbin, ChinaTaking people
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing, ChinaTaking people
- Guangxi Medical University Affiliated Tumor HospitalNanning, ChinaTaking people
- Ningbo First HospitalNingbo, ChinaTaking people
- Huashan Hospital, Fudan UniversityShanghai, ChinaTaking people
- Renji Hospital Shanghai Jiao Tong University School of MedicineShanghai, ChinaTaking people
- Shanghai Tenth People's HospitalShanghai, ChinaTaking people
- The Second Hospital of Tianjin Medical UniversityTianjin, ChinaTaking people
- Tongji Hospital Tongji Medical,Science & TechnologyWuhan, ChinaTaking 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.