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

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.

Trial Details

NCT ID
NCT07218380
Phase
PHASE3
Sponsor
Eli Lilly and Company
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • Vepugratinib
  • Placebo
  • EV
  • Pembrolizumab
Locations (sample)
  • Huntsville, Alabama, United States|34.7304,-86.58594
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Irvine, California, United States|33.66946,-117.82311
  • Orange, California, United States|33.78779,-117.85311
  • Denver, Colorado, United States|39.73915,-104.9847

Key Eligibility Criteria

  • Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than sma…
  • Have a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration determined via molecular testing from a tumor or blood sample obta…
  • 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.

For full eligibility, visit ClinicalTrials.gov.

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