A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
18 Years and older, Male and Female
SGN22E-004 (primary)
NCI-2021-13113
2023-503388-40-00
C5701004
EV-104
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.
Eligibility
- Histologically confirmed, non-muscle invasive urothelial carcinoma with carcinoma in situ (CIS) (with or without papillary disease)
- Predominant histologic component (>50 percent) must be urothelial (transitional cell) carcinoma
- Participants must have high-risk Bacillus Calmette-Guerin (BCG) - unresponsive disease, defined as (where adequate BCG therapy is defined as one of the following: 5 of 6 doses of an initial induction course + at least 2 of 3 doses maintenance therapy or 5 of 6 doses of an initial induction course + at least 2 of 6 doses of a second induction course):
- Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy.
- Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy, or
- T1 high-grade disease at the first evaluation following an induction BCG course (at least 5 or 6 doses)
- Participant must be ineligible for or refusing a radical cystectomy
- All visible papillary Ta/T1 tumors must be completely resected within 60 days prior to enrollment.
- Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2.
**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...
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