A Phase III Study Comparing Enfortumab Vedotin with Chemotherapy in Patients with Previously Treated Locally Advanced or Metastatic Urothelial Cancer

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Full Title

An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects with Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) (WIRB)

Purpose

Nearly all urothelial cancers have high levels of a protein called Nectin-4. Enfortumab vedotin 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 expressing this protein.

The purpose of this study is to compare the effectiveness of enfortumab vedotin with standard docetaxel or paclitaxel chemotherapy in patients with advanced urothelial cancer that continues to grow despite prior treatment with a platinum-containing drug and immunotherapy. Patients will be randomly assigned to receive either enfortumab vedotin or standard chemotherapy with either docetaxel or paclitaxel. All of the medications used in this study are 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 an advanced urothelial cancer (bladder, renal pelvis, ureter, or urethra cancer) that has continued to grow despite treatment with a platinum-containing drug (such as cisplatin) and an immunotherapy drug (such as nivolumab, pembrolizumab, durvalumab, avelumab, or atezolizumab).
  • At least 2 weeks must pass between the completion of prior treatment (4 weeks since radiation therapy or major surgery) and entry into 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

18-552

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators