Study on New Treatments with Enfortumab Vedotin and Pembrolizumab for Urothelial Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT07232602
This clinical trial is exploring new treatment options for people with advanced urothelial cancer, using a combination of enfortumab vedotin and pembrolizumab. The study aims to assess the safety and effectiveness of these treatments in shrinking or eliminating cancer.
Patient Parameters
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Program Overview
Researchers are testing new treatments for people with urothelial cancer (UC) that has spread or cannot be removed by surgery. The usual treatment for this type of cancer includes enfortumab vedotin (EV) and pembrolizumab. This study aims to find out if adding new treatments to the standard ones is safe and if it helps more people see their cancer shrink or disappear.
Description
This study is part of a larger research project called MK-3475-U04 (KEYMAKER-U04). It focuses on finding better ways to treat urothelial cancer by combining new treatments with the standard ones, enfortumab vedotin and pembrolizumab. The study will look at how safe these new treatments are when used together and how well they work in reducing cancer size or making it go away.
Eligibility Criteria
Inclusion Criteria
- Have urothelial cancer that is advanced and cannot be removed by surgery or has spread to other parts of the body.
- Provide a recent or stored tumor sample for testing.
- Have not received any previous treatment for advanced urothelial cancer.
- If living with HIV, must have it well controlled with medication.
- If previously infected with hepatitis B, must have been treated and have no detectable virus before starting the study.
- If previously infected with hepatitis C, must have no detectable virus before starting the study.
Exclusion Criteria
- Have severe eye conditions like dry eye syndrome or corneal disease that affects healing.
- Have active eye infections or ulcers.
- Have inflammatory bowel disease needing medication or a history of such conditions.
- Have serious heart or blood vessel problems in the last 6 months.
- Have uncontrolled diabetes.
- Have fluid buildup around the lungs, heart, or abdomen that causes symptoms or needs frequent drainage.
- Have an active autoimmune disease needing treatment in the last 2 years.
- Have another cancer that is growing or needed treatment in the last 2 years.
- Have cancer that has spread to the brain or spinal cord.
- Have lung disease that needed steroids or currently have lung disease.
- Have an active infection needing treatment.
- If living with HIV, have a history of certain related diseases.
- Have both hepatitis B and C infections at the same time.
- Have had a stem cell or organ transplant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCSF Medical Center at Mission Bay ( Site 5044) | 94158 | San Francisco | California |
| Cleveland Clinic Taussig Cancer ( Site 5036) | 44195 | Cleveland | Ohio |
| Huntsman Cancer Institute ( Site 5041) | 84112-5550 | Salt Lake City | Utah |
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