A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Active:	Yes
Cancer Type:	Bladder Cancer	NCT ID:	NCT05014139
Trial Phases:	Phase I	Protocol IDs:	SGN22E-004 (primary) NCI-2021-13113 2023-503388-40-00 C5701004 EV-104
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Astellas Pharma US Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT05014139

Summary

This study will test a drug called enfortumab vedotin in participants with a type of
bladder cancer called non-muscle invasive bladder cancer (NMIBC).

This study will also evaluate what the side effects are and if the drug works to treat
NMIBC. A side effect is anything a drug does to your body besides treating your disease.

In this study enfortumab vedotin will be put into the bladder using a catheter. A
catheter is a thin tube that can be put into your bladder.

Objectives

The study will be comprised of 2 parts. The first part (dose escalation) will find the
highest dose of enfortumab vedotin that does not cause unacceptable side effects in
participants. The second part (dose expansion) will use the dose found in the first part
to test how well the drug works.

All participants will receive enfortumab vedotin. Treatment on the study will occur
during the induction and maintenance phases, and participants will enter a follow-up
period after completion of the maintenance phase.

**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.