Last updated on November 2018

A Study of Enfortumab Vedotin Plus Pembrolizumab and/or Chemotherapy for Patients With Urothelial Bladder Cancer (EV-103)

Brief description of study

This study will test an experimental drug (enfortumab vedotin) with different combinations of pembrolizumab and/or chemotherapy. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. This study will have different parts to look at the side effects of (1) enfortumab vedotin with pembrolizumab, (2) enfortumab vedotin with chemotherapy, and (3) enfortumab vedotin with pembrolizumab and chemotherapy. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.

Detailed Study Description

This study will examine the safety and anticancer activity of enfortumab vedotin given intravenously in combination with pembrolizumab and/or chemotherapy to patients with locally advanced or metastatic urothelial cancer. The primary goal of the study is to determine the safety and tolerability of enfortumab vedotin in combination with pembrolizumab and/or chemotherapy. The study will be conducted in multiple parts: dose escalation (enfortumab vedotin + pembrolizumab) and dose expansion (cohorts of enfortumab vedotin + pembrolizumab and/or chemotherapy).

Clinical Study Identifier: NCT03288545

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Recruitment Status: Open

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