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

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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).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have previously untreated muscle-invasive bladder cancer and be planning to have the bladder surgically removed (radical cystectomy).
  • Patients’ cancers must have spread to the nearby lymph nodes.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. David Aggen at 646-422-4679.

Protocol

21-316

Phase

II

Disease Status

Newly Diagnosed

Investigator