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
Eli Lilly and Company
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 (REC…
Interventions
- DrugVepugratinib
Administered orally
- OtherPlacebo
Administered orally
- DrugEV
Administered by IV infusion
- DrugPembrolizumab
Administered by IV infusion
Locations (281)
- Clearview Cancer InstituteHuntsville, Alabama
- The University of Arizona Cancer Center - North CampusTucson, Arizona
- Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - IrvineIrvine, California
- TRIO-US (Translational Research in Oncology-US)Los Angeles, California
- UCLA Hematology/Oncology - Santa MonicaLos Angeles, California
- University of California, Irvine (UCI) Health - UC Irvine Medical CenterOrange, California