OncoMatch/Clinical Trials/NCT07218380
A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
Official title: 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
Is NCT07218380 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies multiple treatments including Vepugratinib and EV for carcinoma, transitional cell.
Treatment: Vepugratinib · EV · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: FGFR3 genetic alteration
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
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy
Exception: prior neoadjuvant or adjuvant systemic therapy allowed if no unresolved toxicities > Grade 1
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Clearview Cancer Institute · Huntsville, Alabama
- The University of Arizona Cancer Center - North Campus · Tucson, Arizona
- 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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07218380 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require FGFR3?
Yes, FGFR3 genetic alteration is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages