A Phase II Study of Enfortumab Vedotin and Pembrolizumab Immunotherapy Given Before Surgery in People with Bladder Cancer

Full Title

Enfortumab Vedotin in Combination with Pembrolizumab for Locally Advanced and/or Node Positive Urothelial Carcinoma Prior to Surgery (EV-ECLIPSE)

Purpose

Researchers in this study are assessing the combination of enfortumab vedotin with pembrolizumab immunotherapy in people with bladder cancer that has spread to nearby lymph nodes and will be surgically removed. Both medications are already used to treat bladder cancer, but their use together before surgery is considered investigational. Both drugs help the immune system attack and kill cancer cells. The study investigators will see if this combination treatment can get rid of cancer in the lymph nodes and shrink patients’ tumors before surgery.

Enfortumab vedotin is composed of an antibody that targets a protein on bladder cancer cells called Nectin-4, attached to an anticancer drug that can kill cancer cells containing this protein. Pembrolizumab works by boosting the power of the immune system to find and kill cancer cells. Both drugs are given intravenously (by vein).

Protocol
21-316
Phase
Phase II (phase 2)
Disease Status
Newly Diagnosed
Investigator
ClinicalTrials.gov ID
NCT05239624