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โ† Trials
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A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract

RecruitingPhase 3Ages 18 Years - anyAllEli Lilly and Company
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • Vepugratinib
  • Placebo
  • EV
  • Pembrolizumab
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Where

276 sites
The University of Arizona Cancer Center - North Campus
Tucson, United States
University of Arkansas for Medical Sciences
Little Rock, United States
Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine
Irvine, United States
TRIO-US (Translational Research in Oncology-US)
Los Angeles, United States
UCLA Hematology/Oncology - Santa Monica
Los Angeles, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, United States
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, United States
UCSF Medical Center at Mission Bay
San Francisco, United States

โ€ฆand 268 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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