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
18 Years and older, Male and Female
This is a study that will test how an experimental drug (enfortumab vedotin) combined with a kind of anticancer drug called an immune checkpoint inhibitor (CPI) affects 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. Patients will get the drugs twice every 21-day cycle. Patients will get enfortumab vedotin plus the CPI on day 1. Patients will get enfortumab vedotin only on day 8. This study will look at the side effects of giving the two drugs with each other. 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 treatment.
This study will examine the safety and anticancer activity of enfortumab vedotin given
intravenously in combination with CPI therapy 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 CPI therapy.
The study will be conducted in 2 parts: dose escalation (enfortumab vedotin + pembrolizumab)
and dose expansion (cohorts of enfortumab vedotin + CPI [either pembrolizumab or