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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: N/A
  • NCT 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 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.

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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

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 (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.
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

- * Participant 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: Janet Trowbridge, MD

Role: Study Director

Affiliation: Seagen Inc.

Overall Contact

Name: Seagen, Inc. Trial Information Support

Phone: 866-333-7436

Email: clinicaltrials@seagen.com

LOCATION

Facility Status Contact
Facility: Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Status: Recruiting Contact: N/A
Facility: Mayo Clinic
Scottsdale, Arizona 85259
United States
Status: Recruiting Contact: N/A
Facility: UCLA Department of Medicine - Hematology & Oncology
Los Angeles, California 90095
United States
Status: Recruiting Contact: N/A
Facility: University of California, Irvine
Orange, California 92868
United States
Status: Recruiting Contact: N/A
Facility: University of California at San Francisco
San Francisco, California 94134
United States
Status: Recruiting Contact: N/A
Facility: Northwestern University-Feinberg School of Medicine
Chicago, Illinois 60611
United States
Status: Recruiting Contact: N/A
Facility: Rush University Medical Center
Chicago, Illinois 60612
United States
Status: Recruiting Contact: N/A
Facility: Markey Cancer Center / University of Kentucky
Lexington, Kentucky 40508
United States
Status: Recruiting Contact: N/A
Facility: Johns Hopkins Medical Center
Baltimore, Maryland 21287
United States
Status: Recruiting Contact: N/A
Facility: James Cancer Hospital / Ohio State University
Columbus, Ohio 43221
United States
Status: Recruiting Contact: N/A
Facility: Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania 19107
United States
Status: Recruiting Contact: N/A
Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: N/A
Facility: Erlanger Oncology and Hematology
Chattanooga, Tennessee 37403
United States
Status: Recruiting Contact: N/A
Facility: University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Status: Recruiting Contact: N/A
Facility: MD Anderson
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A
Facility: Urology San Antonio
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A
Facility: Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
Seattle, Washington 98195
United States
Status: Recruiting Contact: N/A