A Phase II Study of Enfortumab Vedotin (ASG-22CE) in Patients with Advanced Urothelial Cancers Previously Treated with Immunotherapy

Full Title

SGN22E-001: A Single-Arm, Open-Label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Immune Checkpoint Inhibitor (CPI) Therapy

Purpose

Most urothelial cancers have high levels of a protein called Nectin-4. Enfortumab vedotin (ASG-22CE) is an investigational drug designed to treat cancers containing this protein. Enfortumab vedotin is composed of an antibody that targets Nectin-4, attached to an anticancer drug that can kill cancer cells containing this protein.

In this study, researchers want to determine the anticancer activity of enfortumab vedotin in patients with inoperable or metastatic urothelial (bladder, urethra, ureter, or renal pelvis) cancers that have continued to grow despite prior “immune checkpoint blockade.” Immune checkpoint blockade is a type of cancer immunotherapy that boosts the power of the immune system to find and kill cancer cells, but some urothelial cancers continue to grow despite this treatment.

Enfortumab vedotin is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic urothelial cancer that has continued to grow despite treatment that included an immunotherapy drug called a “checkpoint inhibitor,” such as atezolizumab, pembrolizumab, durvalumab, avelumab, or nivolumab.
  • Patients must recover from the serious side effects of previous treatments before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jonathan Rosenberg at 646-888-4741.

Protocol

18-072

Phase

II

Investigator

Co-Investigators