Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

Active:	Yes
Cancer Type:	Unknown Primary	NCT ID:	NCT04223856
Trial Phases:	Phase III	Protocol IDs:	SGN22E-003 (primary) NCI-2020-01070 2019-004542-15 MK-3475-A39
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/NCT04223856

Summary

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab)
work together to treat patients with urothelial cancer. The study will compare these drugs to
other drugs that are usually used to treat this cancer (standard of care). The patients in
this study will have cancer that has spread from their urinary system to other parts of their
body.

Objectives

Japan PMDA has approved enfortumab vedotin (Padcev) for the treatment of advanced urothelial
cancer. The study will continue as a post marketing study in Japan.

This study is being conducted to evaluate the combination of enfortumab vedotin +
pembrolizumab versus standard of care gemcitabine + platinum-containing chemotherapy, in
subjects with previously untreated locally advanced or metastatic urothelial cancer.

Enfortumab vedotin may be administered for an unlimited number of cycles until a protocol
defined reason for study discontinuation occurs. Pembrolizumab may be administered for a
maximum of 35 cycles or a protocol-defined reason for study discontinuation occurs, whichever
is first. Cisplatin or carboplatin plus gemcitabine may be administered for a maximum of 6
cycles or a protocol-defined reason for study discontinuation occurs, whichever is first.

Treatment Sites in Georgia

Georgia Cancer Center at Augusta University
1411 Laney Walker Boulevard
Augusta, GA 30912
www.augusta.edu/cancer/

**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.