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New treatment option for Carcinoma, Transitional Cell
Official title A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
ClinicalTrials.gov ID: NCT07218380
What this study is testing
What is Vepugratinib?
Vepugratinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for carcinoma, transitional cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small...
- Have a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration determined via molecular testing from a tumor or blood sample...
- 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
You likely can't join if
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Torrance, California, United States
- Denver, Colorado, United States
- Grand Junction, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Orlando, Florida, United States
- Boise, Idaho, United States
- Chicago, Illinois, United States
- Evanston, Illinois, United States
- Fort Wayne, Indiana, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
+ 198 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Irvine, California, United States; Los Angeles, California, United States; Orange, California, United States and 212 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.