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

Detailed criteria

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

Drug
Vepugratinib
Administered orally
Other
Placebo
Administered orally
Drug
EV
Administered by IV infusion
Drug
Pembrolizumab
Administered by IV infusion

Locations (284)

The University of Arizona Cancer Center - North Campus
Tucson, Arizona
520-626-4703
University of Arkansas for Medical Sciences
Little Rock, Arkansas
Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine
Irvine, California
TRIO-US (Translational Research in Oncology-US)
Los Angeles, California
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California