This study focuses on individuals with Urothelial Carcinoma, a type of cancer that starts in the lining of the urinary tract, which may include Urinary Bladder Neoplasms. The research specifically targets cases that are locally advanced or have experienced Neoplasm Metastasis, meaning the cancer has spread to other parts of the body. The study is also focused on patients whose cancer has an FGFR3 genetic alteration, which is a specific change in the DNA of the cancer cells.
The purpose of this study is to test the effectiveness and safety of a new drug called vepugratinib compared to a placebo. Participants in the study will receive a combination of treatments. This includes vepugratinib or a placebo taken as an oral tablet, along with enfortumab vedotin and pembrolizumab, which are administered through intravenous use, meaning they are delivered directly into a vein. The study is designed so that neither the participants nor the researchers know which specific treatment is being administered during the process.
During the study, participants will undergo regular medical monitoring to track the progress of the treatment. The involvement in this clinical trial may last for up to approximately 6 years.
Who Can Join the Study?
You have urothelial cancer, which is a type of cancer that starts in the cells lining the urinary tract, and this cancer has spread to other parts of your body and cannot be treated with surgery.
Your cancer cells show a specific genetic change in a gene called FGFR3, which is a piece of your DNA that can be identified through a tumor or blood sample.
Your tumors must be large enough to be measured by a doctor using a standard method called RECIST v1.1, which is a specific set of rules used to track how much a tumor grows or shrinks.
You have a moderate to good level of physical ability, meaning you are able to take care of yourself and perform daily activities.
Your laboratory test results, which are the findings from your blood and other medical tests, must be within a healthy or acceptable range.
You are either male or female.
You fall within the required age range specified for this study.
Who Cannot Join the Study?
You have already received treatment for metastasis, which means cancer that has traveled from its original location to other parts of your body.
You are still experiencing side effects from a previous cancer treatment that are more than mild, meaning they are moderate or severe.
You have nerve damage, which is a problem with your nervous system that changes how you feel sensations or how you move your body.
You have cancer in your brain that is either not being treated or is not currently under control.
You have eye problems, such as corneal keratopathy (a condition affecting the clear front surface of the eye) or retinal disorder (a problem with the light-sensitive layer at the back of the eye), that are causing symptoms or have not been treated.
LOXO-435 is the code name for the test medication (also known as vepugratinib) being studied. It is an oral tablet taken by mouth that is being tested to see if it can help treat patients with specific types of advanced bladder cancer.
Pembrolizumab is a medication given through an intravenous infusion (into a vein) that works as a type of immunotherapy to help the body’s immune system fight cancer cells.
Enfortumab vedotin is a medication given through an intravenous infusion (into a vein) that is designed to target and kill cancer cells directly.
Transitional Cell Carcinoma – This is a type of cancer that starts in the cells lining the urinary tract. These cells are known as transitional cells because they have the ability to stretch and change shape. The disease often begins in the bladder but can involve other parts of the urinary system. Over time, the abnormal cells can grow into a mass and spread to nearby tissues.
Urinary Bladder Neoplasms – These are abnormal growths of cells located within the urinary bladder. These growths can be either non-cancerous or cancerous. When the growths are cancerous, they can develop within the bladder lining. As the disease progresses, the cells may multiply uncontrollably and invade the bladder wall.
Neoplasm Metastasis – This refers to the process where cancer cells spread from their original location to other parts of the body. The cells break away from the primary tumor and travel through the blood or the lymph system. Once they reach a new organ or tissue, they begin to grow new tumors. This process represents an advanced stage of the original disease.
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