A Phase 2 Study of Enfortumab Vedotin in People with Urothelial Cancer of the Upper Urinary Tract

In the U.S.

Full Title

Neoadjuvant Enfortumab Vedotin in High-Grade Urothelial Carcinoma of the Upper Urinary Tract (including Ureter and Renal Pelvis)

Purpose

Urothelial cancers can grow in different parts of the urinary tract. This includes the ureter (the tube that carries urine from the kidneys to the bladder) and renal pelvis. The renal pelvis is where the ureter connects to the kidneys. The standard treatment is surgery to remove the ureter, kidney, or both. In this study, researchers want to see if enfortumab vedotin, given before surgery, is useful for treating urothelial cancers. The people in this study have high-risk urothelial cancers of the upper urinary tract. High risk means there is a greater chance of the cancer coming back after treatment.

Enfortumab vedotin delivers chemotherapy directly to cancer cells. It attaches to the surface of cancer cells and releases anti-cancer medication inside the cells. This treatment is used regularly for patients with urothelial cancers which have already spread to other parts of the body. If you join this study, you will have enfortumab vedotin before standard surgery to remove your tumor. Enfortumab vedotin is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

Have urothelial cancer of the ureter or renal pelvis that will not be treated using standard cisplatin chemotherapy.
Not have had prior treatment for urothelial cancer (other than BCG, which is allowed).
Not have metastatic disease (cancer that has spread).
Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
Be age 18 or older.