A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

Active:	No
Cancer Type:	Bladder Cancer Kidney Cancer Unknown Primary Ureter Cancer Urethral Cancer	NCT ID:	NCT03288545
Trial Phases:	Phase I Phase II	Protocol IDs:	SGN22E-002 (primary) NCI-2017-01927
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Astellas Pharma Global Development, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT03288545

Summary

This study will test an experimental drug (enfortumab vedotin) alone and with different
combinations of anticancer therapies. 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. Some parts of the study will look at locally advanced or metastatic urothelial
cancer (la/mUC), which means the cancer has spread to nearby tissues or to other areas of
the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC),
which is cancer at an earlier stage that has spread into the muscle wall of the bladder.
This study will look at the side effects of enfortumab vedotin alone and with other
anticancer therapies. 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.

Objectives

This study will examine the safety and anticancer activity of enfortumab vedotin (EV)
given intravenously as monotherapy and in combination with other anticancer therapies as
first line (1L) and second line (2L) treatment for patients with urothelial cancer. The
primary goal of the study is to determine the safety, tolerability, and efficacy of
enfortumab vedotin alone and in combination with pembrolizumab and/or chemotherapy. The
study will be conducted in multiple parts:

Locally advanced or metastatic urothelial cancer:

- Dose escalation

- Expansion

- Part 1: Cohorts A and Optional B

- Part 2: Cohorts D, E, and Optional F

- Part 3: Cohort G.

- Randomized Cohort K

- EV Monotherapy Arm

- EV Combination Arm

Muscle invasive bladder cancer:

- Cohort H

- Optional Cohort J

- Cohort L

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.