Study on Vepugratinib for Treating Advanced Urinary Tract Cancer
Sponsor: Eli Lilly and Company
ClinicalTrials ID:NCT07218380
This clinical trial is testing a new drug, vepugratinib, to see if it is safe and effective for people with advanced bladder cancer. The study compares vepugratinib with a placebo, both given alongside other cancer treatments, enfortumab vedotin and pembrolizumab. Participation may last up to 6 years.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to evaluate the safety and effectiveness of a new medication called vepugratinib for patients with advanced or spreading bladder cancer. Participants will receive either vepugratinib or a placebo, in combination with two other cancer drugs, enfortumab vedotin and pembrolizumab. The study will help determine if vepugratinib can improve treatment outcomes for these patients.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic bladder cancer that cannot be removed by surgery.
- Have a specific genetic change in the FGFR3 gene, identified through testing of a tumor or blood sample.
- Have at least one tumor that can be measured by doctors using standard criteria.
- Be in relatively good health, with an activity level that allows for some daily activities.
- Have acceptable results on certain lab tests.
Exclusion Criteria
- Have previously received treatment for advanced bladder cancer.
- Have any ongoing side effects from previous cancer treatments that are more than mild.
- Have ongoing nerve problems affecting movement or sensation that are moderate or severe.
- Have untreated or uncontrolled cancer spread to the brain or a history of cancer in the brain lining.
- Have current eye problems affecting the cornea or retina, confirmed by an eye exam.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Clearview Cancer Institute | 35805 | Huntsville | Alabama |
| The University of Arizona Cancer Center - North Campus | 85719 | Tucson | Arizona |
| TRIO-US (Translational Research in Oncology-US) | 90024 | Los Angeles | California |
| UCLA Hematology/Oncology - Santa Monica | 90404 | Los Angeles | California |
| UCSF Medical Center at Mission Bay | 94158 | San Francisco | California |
| Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer (TMPN) | 90505 | Torrance | California |
| AdventHealth Medical Group - Porter | 80210 | Denver | Colorado |
| Colorado West Healthcare System - Grand Valley Oncology | 81505 | Grand Junction | Colorado |
| AdventHealth Celebration | 34747 | Celebration | Florida |
| St. Luke's Cancer Institute: Boise | 83712 | Boise | Idaho |
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