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A Study of Vepugratinib for Urinary Tract Cancers

This study is testing a new treatment, vepugratinib, for people with advanced or spreading bladder cancer (urothelial cancer). Vepugratinib will be given along with enfortumab vedotin (EV) and pembrolizumab. Some participants will receive a placebo (an inactive substance) instead of vepugratinib, also with EV and pembrolizumab. Researchers want to see if vepugratinib is safe and effective. To join, you must have a specific genetic change (FGFR3 alteration) in your tumor or blood. The study will look at side effects, how many people respond to the treatment, and how long people live without their cancer getting worse. This study is currently recruiting participants.

Study design
This interventional study plans to enroll 450 participants. It compares vepugratinib plus other drugs to a placebo plus other drugs.
What's involved
Study participation could last up to approximately 6 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety up to 90 months, and for progression-free survival for an estimated 6 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07218380

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Eli Lilly and Company
~450 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:VepugratinibPlaceboEVPembrolizumab

At a glance

Recruiting sites
119 of 290 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-related adverse events related to vepugratinib in combination with EV and pembrolizumab
Measured over From baseline up to 90 months
+2 more outcomes measured

Conditions

Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Neoplasm Metastasis

Explore related trials

Urothelial CarcinomaFibroblast Growth Factor Receptor 3

Where it's being run

290 sites across 46 states
Spain26
Brazil25
China25
Germany25
Japan20
France12
Poland12
Taiwan11

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 (RECIST) v1.1
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Have adequate laboratory parameters

Exclusion

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.
Have ongoing sensory or motor neuropathy of Grade 2 or higher
Have untreated or uncontrolled central nervous system (CNS) involvement or any history of leptomeningeal disease.
Current evidence corneal keratopathy or retinal disorder confirmed by ocular examination at screening.

What this trial measures

  • Number of participants with treatment-related adverse events related to vepugratinib in combination with EV and pembrolizumabFrom baseline up to 90 months
  • Safety Lead-in: Overall Response Rate (ORR)From baseline up to 90 months

    ORR by Investigator Assessment.

  • Progression-free Survival (PFS)Baseline to Study Completion (estimated as 6 years)

    PFS by blinded independent committee review (BICR).