A Phase IB Study of Enfortumab Vedotin plus Immunotherapy for Patients with Locally Advanced or Metastatic Urothelial Cancer

Full Title

A Phase 1b Dose-Escalation and Dose-Expansion Study of Enfortumab Vedotin (ASG-22CE) in combination with Immune Checkpoint Inhibitor (CPI) Therapy for Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer

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 are assessing the safety and preliminary effectiveness of giving enfortumab vedotin in combination with “immune checkpoint blockade,” a form of immunotherapy which boosts the power of the immune system to find and kill cancer cells. Patients will receive enfortumab vedotin with either pembrolizumab or atezolizumab. These immunotherapy drugs are both used to treat urothelial cancers, but in some patients the cancer continues to grow. It is hoped that combining immune checkpoint blockade with enfortumab vedotin will be more effective than immunotherapy alone.

All medications used in this study are given intravenously.

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 either has not yet been treated with chemotherapy or, in some cases, persists despite platinum-based chemotherapy.
  • Patients may not have previously received immune checkpoint blockade therapy.
  • At least 4 weeks must pass between the completion of previous treatment and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • 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

18-319

Phase

I

Disease Status

Newly Diagnosed

Investigator

Co-Investigators