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

Conditions

• Carcinoma, Transitional Cell
• Neoplasm Metastasis
• Urinary Bladder Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vepugratinib — DRUG
  Administered orally
• Placebo — OTHER
  Administered orally
• EV — DRUG
  Administered by IV infusion
• Pembrolizumab — DRUG
  Administered by IV infusion

Study Details

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.

Key Dates

Start date

Dec 12, 2025

Status verified

Jun 2026

Primary completion

Oct 31, 2029

Completion

May 31, 2033

Study Design

Enrollment

450 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Vepugratinib + EV + Pembrolizumab (Safety Lead In)
  Vepugratinib administered orally with EV + pembrolizumab administered IV
• Experimental: Vepugratinib + Enfortumab Vedotin (EV) + Pembrolizumab
  Vepugratinib administered orally, and EV + pembrolizumab administered by intravenous (IV) infusion.
• Placebo Comparator: Placebo + EV + Pembrolizumab
  Placebo administered orally, and EV + pembrolizumab administered by IV infusion.

Primary Outcome Measure

Number of participants with treatment-related adverse events related to vepugratinib in combination with EV and pembrolizumab [ Time Frame: From baseline up to 90 months ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (60)

Find similar trials in Huntsville, AL

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