Vepugratinib for low grade bladder cancer and upper urinary tract cancer with FGFR3 changes
Tests vepugratinib in adults with low grade bladder or upper urinary tract cancer.
Plain-language title generated from the registry record
Registry title: A Study of Vepugratinib (LY3866288) in Adults With Non-Muscle Invasive Bladder Cancer and Upper Tract Urothelial Cancer
Key facts
- Where
- Myrtle Beach, United StatesSee the site
- Phase
- Phase 2
Where in United States
- Carolina Urologic Research CenterMyrtle Beach, United StatesNo longer taking part
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
- NCT07827612
- Record updated
- 8 October 2026
- Original description
The main purpose of this study is to see how well vepugratinib works in adults with low grade, intermediate risk, non-muscle invasive bladder cancer (LG IR NMIBC) or low-grade upper tract urothelial carcinoma (LG UTUC). Safety tests will also be conducted.Read full original descriptionShow less
FORAY: A Phase 2, Randomized, Open-Label Study Evaluating Vepugratinib in Adults With FGFR3 Altered Low Grade, Intermediate Risk, Non-muscle Invasive Bladder Cancer and Low Grade Upper Tract Urothelial Carcinoma
The main purpose of this study is to see how well vepugratinib works in adults with low grade, intermediate risk, non-muscle invasive bladder cancer (LG IR NMIBC) or low-grade upper tract urothelial carcinoma (LG UTUC). Safety tests will also be conducted.
For each participant, the study will last up to 5 years.
Inclusion: All Participants:; Have a PS of 0 to 2 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale; Cohort A; Have histologically confirmed LG NMIBC; Have LG IR NMIBC at time of screening; Have a documented qualifying fibroblast growth factor receptor 3 protein (FGFR3) mutation or fusion; Cohort B; Have histologically confirmed LG UTUC.
Exclusion: All Participants; Have had a prior positive urine cytology within 6 weeks of first day of treatment; Have received prior local instillation (for example, intravesical chemotherapy, Bacillus Calmette-Guerin, Jelmyto) therapy within 8 weeks of the first day of treatment; Cohort A; Have synchronous UTUC disease; Have presence of, or history of, high-grade urothelial carcinoma within 3 years of the first day of treatment, or presence of, or history of, carcinoma in situ; Cohort B; Have presence of bladder tumors at the time of enrollment; Have presence of, or history of, high-grade urothelial carcinoma or carcinoma in situ.