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OncoMatch/Clinical Trials/NCT07218380

A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract

Is NCT07218380 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Vepugratinib and EV for carcinoma, transitional cell.

Phase 3RecruitingEli Lilly and CompanyNCT07218380Data as of May 2026

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.

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Extracted eligibility criteria

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

No prior treatment (treatment-naive required)
Max 0 prior lines

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 →

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