Back to Clinical Trials

Brief Title: Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

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

INTRODUCTION

  • Org Study ID: SGN22E-004
  • Secondary ID: EV-104
  • NTC ID: NCT05014139
  • Sponsor: Astellas Pharma Global Development, Inc.

BRIEF 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.

DETAILED DESCRIPTION

The study will comprise 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.

  • Overall Status
    Recruiting
  • Start Date
    December 7, 2021
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of adverse events (AEs)

Primary Outcome 1 - Timeframe: Approximately 1 year

Primary Outcome 2 - Measure: Incidence of laboratory abnormalities

Primary Outcome 2 - Timeframe: Approximately 1 year

Primary Outcome 3 - Measure: Incidence of dose limiting toxicities (DLTs)

Primary Outcome 3 - Timeframe: Approximately 7 weeks

CONDITION

  • Urinary Bladder Neoplasms
  • Carcinoma in Situ
  • Carcinoma Transitional Cell
  • Non-muscle Invasive Bladder Cancer
  • NMIBC

ELIGIBILITY

Inclusion Criteria:
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:
Persistent or recurrent CIS alone or with recurrent Ta/T1 disease within 12 months of completion of adequate BCG therapy. (Ta/T1: noninvasive papillary disease/tumor invades the subepithelial connective tissue). 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

- 5 of 6 doses of an initial induction course + at least 2 of 6 doses of a second induction course

- 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.
Exclusion Criteria:
Current or prior history of muscle-invasive urothelial carcinoma or metastatic disease.

- Nodal or metastatic disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) within 3 months prior to study treatment

- Concomitant upper tract urothelial carcinoma as noted on CT or MRI urogram performed within 3 months prior to study treatment

- Prior or concomitant urothelial carcinoma of the prostatic urethra within 6 months prior to study treatment

- Participants with tumor-related hydronephrosis

- Participant has received other systemic anticancer therapy including chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, and/or investigational agent within 4 weeks or intravesical therapy within 6 weeks of first dose of study treatment

- Subject has had any prior radiation to the bladder for urothelial cancer

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Sujata Narayanan, MD

Role: Study Director

Affiliation: Seagen Inc.

Overall Contact

Name: Sujata Narayanan, MD

Phone: 866-333-7436

Email: clinicaltrials@seagen.com

LOCATION

Facility Status Contact
Facility: Johns Hopkins Medical Center
Baltimore, Maryland 21287
United States
Status: Recruiting Contact: N/A
Facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United States
Status: Recruiting Contact: N/A
Facility: MD Anderson
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A