A Phase III Study of Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone for Untreated Locally Advanced or Metastatic Urothelial Cancer

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Full Title

An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer

Purpose

Researchers in this study are comparing two treatment regimens for people with inoperable or metastatic urothelial cancers, such as bladder, urethra, ureter, or renal pelvis cancer. Patients will be randomly assigned to receive either enfortumab vedotin plus pembrolizumab immunotherapy, or standard chemotherapy with gemcitabine plus either cisplatin or carboplatin.

Most urothelial cancers have high levels of a protein called Nectin-4. Enfortumab vedotin is 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. Pembrolizumab is an immunotherapy drug that releases the brakes on the immune response, allowing immune cells to find and destroy cancer cells.

Enfortumab vedotin is approved by the U.S. Food and Drug Administration to treat patients with inoperable or metastatic urothelial cancers that persist despite prior treatment with immunotherapy and chemotherapy. In this study, it is being evaluated as initial treatment for these cancers. The treatments 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 locally advanced or metastatic urothelial cancer that has not previously been treated with enfortumab vedotin or immunotherapy. Prior chemotherapy is permitted as long as it ended more than 1 year before receiving the study therapy.
  • 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. Gopa Iyer 646-888-4737.

Protocol

20-262

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators