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

NCT05014139 | Terminated Phase 1 FDA Drug

• 4 other identifiers: SGN22E-004EV-104C57010042023-503388-40-00
• Study Type: interventional
• Target: 37
• Locations: 6 countries
• Sites: 32

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.

Conditions

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

Keywords

Bladder Cancer; Urothelial Cancer; Enfortumab vedotin; PADCEV; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events (AEs)

  An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  Approximately 1 year

• Incidence of laboratory abnormalities

  To be summarized using descriptive statistics.

  Approximately 1 year

• Incidence of dose limiting toxicities (DLTs)

  To be summarized using descriptive statistics.

  Approximately 7 weeks

Secondary Outcomes (11)

• Pharmacokinetics (PK) of enfortumab vedotin: Area under the concentration-time curve (AUC)

  Approximately 1 year

• PK of enfortumab vedotin: Maximum concentration (Cmax)

  Approximately 1 year

• PK of enfortumab vedotin: Time to maximum concentration concentration (tmax)

  Approximately 1 year

• PK of enfortumab vedotin: Apparent terminal half-life (t1/2)

  Approximately 1 year

• PK of enfortumab vedotin: Trough concentration (Ctrough)

  Approximately 1 year

Study Arms (2)

Enfortumab vedotin: Dose escalation cohort

EXPERIMENTAL

During the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses.

Drug: Enfortumab vedotin

Enfortumab vedotin: Dose expansion cohort

EXPERIMENTAL

During the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses.

Drug: Enfortumab vedotin

Interventions

Enfortumab vedotin DRUG

Given into the bladder (intravesically)

Also known as: PADCEV, ASG-22CE, ASG-22ME

Enfortumab vedotin: Dose escalation cohort; Enfortumab vedotin: Dose expansion cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead
• Seagen, a wholly owned subsidiary of Pfizer: collaborator

Study Sites (32)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

UCLA Department of Medicine - Hematology & Oncology

Los Angeles, California, 90095, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

University of California at San Francisco

San Francisco, California, 94134, United States

Location

Stanford Health Care

Stanford, California, 94305, United States

Location

Northwestern University-Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Markey Cancer Center / University of Kentucky

Lexington, Kentucky, 40508, United States

Location

Johns Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

James Cancer Hospital / Ohio State University

Columbus, Ohio, 43221, United States

Location

Oregon Health and Science University

Portland, Oregon, 98682, United States

Location

Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Erlanger Oncology and Hematology

Chattanooga, Tennessee, 37403, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, 98195, United States

Location

Site CA11001

Toronto, Ontario, M5G 2C1, Canada

Location

Site FR33002

Lyon, 69003, France

Location

Site FR33001

Paris, 75013, France

Location

Site FR33003

Rennes, 35000, France

Location

Site DE49001

Göttingen, 37075, Germany

Location

Site DE49002

Tübingen, 72076, Germany

Location

Site ES34001

Barcelona, 08025, Spain

Location

Site ES34004

Barcelona, 08035, Spain

Location

Site ES34003

Barcelona, 08036, Spain

Location

Site ES34002

Madrid, 28041, Spain

Location

Site UK44002

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma in Situ; Carcinoma, Transitional Cell; Non-Muscle Invasive Bladder Neoplasms

Interventions

enfortumab vedotin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 20, 2021
• Study Start: December 7, 2021
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); US (21); DE (2); GB (1); FR (3); CA (1)