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

Piedmont Cancer Institute
1800 Howell Mill Road
Atlanta, GA 30318

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
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.