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Trial record 1 of 1 for:    NCT03219333
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A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer (EV-201)

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ClinicalTrials.gov Identifier: NCT03219333
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:

This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body.

This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer.

This study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect.

Patients who sign up for this trial must also fall into one of these categories:

  • Patients have already received treatment with platinum-containing chemotherapy
  • Patients have never received platinum-containing treatment and are not eligible for treatment with cisplatin.

Condition or disease Intervention/treatment Phase
Carcinoma, Transitional Cell Urinary Bladder Neoplasms Urologic Neoplasms Renal Pelvis Neoplasms Urothelial Cancer Ureteral Neoplasms Urethral Neoplasms Drug: Enfortumab vedotin Phase 2

Detailed Description:
This study will examine the safety and anticancer activity of enfortumab vedotin given intravenously to patients with locally advanced or metastatic urothelial cancer who previously received a CPI and either previously received platinum-containing chemotherapy (Cohort 1) or are platinum-naïve and cisplatin-ineligible (Cohort 2). Patients who received platinum in the adjuvant/neoadjuvant setting and did not progress within 12 months of completion will be considered platinum-naïve. Approximately 100 patients are expected to be enrolled in each cohort. The primary goal of the study is to determine the confirmed ORR of enfortumab vedotin.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: single-arm, open-label, multi-cohort, multicenter study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Open-label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Immune Checkpoint Inhibitor (CPI) Therapy
Actual Study Start Date : October 8, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Enfortumab vedotin
Enfortumab vedotin on days 1, 8 and 15 every 28 days
Drug: Enfortumab vedotin
Intravenous (IV) infusion on days 1, 8 and 15 every 28 days
Other Names:
  • ASG-22CE
  • ASG-22ME




Primary Outcome Measures :
  1. Objective response rate (ORR) by an independent review facility (IRF) [ Time Frame: Up to 3 years ]
    The proportion of patients with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)


Secondary Outcome Measures :
  1. Duration of response (DOR) by an IRF [ Time Frame: Up to 7.5 years ]
    The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause, whichever comes first

  2. Disease control rate at 16 weeks (DCR16) by an IRF [ Time Frame: 16 weeks ]
    Proportion of patients with CR, PR, or stable disease (SD) at Week 16 visit

  3. Progression free survival (PFS) by an IRF [ Time Frame: Up to 7.5 years ]
    The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first

  4. ORR by investigator assessment [ Time Frame: Up to 7.5 years ]
    Confirmed CR and PR per RECIST 1.1

  5. DOR by investigator assessment [ Time Frame: Up to 7.5 years ]
    The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD or to death due to any cause, whichever comes first

  6. DCR16 by investigator assessment [ Time Frame: 16 weeks ]
    Proportion of patients with CR, PR, or SD at Week 16 visit

  7. Progression free survival (PFS) by investigator assessment [ Time Frame: Up to 7.5 years ]
    The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first

  8. Overall survival (OS) [ Time Frame: Up to 7.5 years ]
    The time from start of study treatment to date of death due to any cause

  9. Incidence of adverse events (AEs) [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 7.5 years ]
    Descriptive statistics will be used to summarize results

  10. Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 7.5 years ]
    Descriptive statistics will be used to summarize results

  11. Pharmacokinetics (PK) parameter for enfortumab vedotin: Maximum concentration (Cmax) [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 7.5 years ]
    Cmax will be derived from the PK blood samples collected

  12. PK parameter for enfortumab vedotin: Trough concentration (Ctrough) [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 7.5 years ]
    Ctrough will be derived from the PK blood samples collected

  13. PK parameter for monomethyl auristatin E (MMAE): Cmax [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 7.5 years ]
    Cmax will be derived from the PK blood samples collected

  14. PK parameter for MMAE: Ctrough [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 7.5 years ]
    Ctrough will be derived from the PK blood samples collected

  15. PK parameter for Total Antibody (TAb): Cmax [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 7.5 years ]
    Cmax will be derived from the PK blood samples collected

  16. PK parameter for Total Antibody (TAb): Ctrough [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 7.5 years ]
    Ctrough will be derived from the PK blood samples collected

  17. Incidence of antitherapeutic antibodies (ATA) to enfortumab vedotin [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 7.5 years ]
    Blood samples for ATA analysis will be collected



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented urothelial carcinoma (squamous differentiation or mixed cell types allowed).
  • Metastatic disease or locally advanced disease that is not resectable.
  • Must have received prior treatment with a CPI in the locally advanced or metastatic urothelial cancer setting. A CPI is defined as a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. Patients who received CPI therapy in the neoadjuvant/adjuvant setting and had recurrent or progressive disease either during therapy or within 3 months of therapy completion are eligible.
  • Must either have prior treatment with platinum-containing chemotherapy (Cohort 1) or be platinum-naïve and ineligible for treatment with cisplatin at time of enrollment (Cohort 2).
  • Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
  • Tumor tissue samples must be available for submission to the sponsor prior to study treatment.
  • Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1 for Cohort 1 or ≤2 for Cohort 2.
  • Anticipated life expectancy of ≥3 months as assessed by the investigator.

Exclusion Criteria:

  • Ongoing sensory or motor neuropathy Grade ≥2.
  • Active central nervous system (CNS) metastases.
  • Immunotherapy related myocarditis, colitis, uveitis, or pneumonitis.
  • Prior enrollment in an enfortumab vedotin study or prior treatment with other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).
  • Uncontrolled tumor-related pain or impending spinal cord compression.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219333


Contacts
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Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

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Locations
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United States, Arizona
Mayo Clinic Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Arizona Oncology Associates, PC - HOPE Recruiting
Tucson, Arizona, United States, 85710
United States, California
University of California Davis Recruiting
Davis, California, United States, 95616
Keck Medical Center / University of Southern California Recruiting
Los Angeles, California, United States, 90033
Keck Medical Center / Newport Beach Recruiting
Newport Beach, California, United States, 92663
Kaiser Permanente Oakland Recruiting
Oakland, California, United States, 94611
Chao Family Comprehensive Cancer Center University of California Irvine Recruiting
Orange, California, United States, 92868
University of California Irvine - Newport Recruiting
Orange, California, United States, 92868
Kaiser Permanente Roseville Recruiting
Roseville, California, United States, 95661
Kaiser Permanente Sacramento Recruiting
Sacramento, California, United States, 95825
Kaiser Permanente San Francisco Recruiting
San Francisco, California, United States, 94115
Kaiser Permanente San Jose Recruiting
San Jose, California, United States, 95119
Kaiser Permanente San Leandro Recruiting
San Leandro, California, United States, 94577
Kaiser Permanente Santa Clara Recruiting
Santa Clara, California, United States, 95051
Kaiser Permanente South San Francisco Recruiting
South San Francisco, California, United States, 94080
Kaiser Permanente Medical Center Northern California Recruiting
Vallejo, California, United States, 94589
Kaiser Permanente Walnut Creek Recruiting
Walnut Creek, California, United States, 94596
United States, Colorado
Rocky Mountain Cancer Centers - Aurora Recruiting
Aurora, Colorado, United States, 80012
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
Ocala Oncology Center Recruiting
Ocala, Florida, United States, 34471
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637-1470
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins Medical Center Recruiting
Baltimore, Maryland, United States, 21231
Maryland Oncology Hematology, P.A. Recruiting
Silver Spring, Maryland, United States, 20904
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute / Wayne State University Recruiting
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
United States, New York
New York Oncology Hematology, P.C. Recruiting
Albany, New York, United States, 12206
New York University (NYU) Cancer Institute Recruiting
New York, New York, United States, 10016
Columbia University Medical Center Recruiting
New York, New York, United States, 10022
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10087-9049
James P. Wilmot Cancer Center / University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic, The Recruiting
Cleveland, Ohio, United States, 44195
James Cancer Hospital / Ohio State University Recruiting
Columbus, Ohio, United States, 43210
United States, Oregon
Northwest Cancer Specialists, P.C. Recruiting
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Hillman Cancer Center / University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Greenville Health System Cancer Institute Recruiting
Greenville, South Carolina, United States, 29615
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37204
United States, Texas
Texas Oncology - Austin Central Recruiting
Austin, Texas, United States, 78731
Texas Oncology - Baylor Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Houston Methodist Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Virginia Oncology Associates Recruiting
Norfolk, Virginia, United States, 23502
United States, Washington
Seattle Cancer Care Alliance / University of Washington Recruiting
Seattle, Washington, United States, 98109-1023
France
Site FR33001 Recruiting
Villejuif-Cedex-France, France
Germany
Site DE49001 Recruiting
Tübingen, Germany
Italy
Site IT39001 Recruiting
Milano, Italy
Japan
Site JP81001 Recruiting
Hirosaki, Aomori, Japan
Site JP81004 Recruiting
Tsukuba, Ibaraki, Japan
Site JP81002 Recruiting
Morioka, Iwate, Japan
Site JP81008 Recruiting
Osakasayama, Osaka, Japan
Site JP81006 Recruiting
Shinjuku-ku, Tokyo, Japan
Site JP81009 Recruiting
Ube, Yamaguchi, Japan
Site JP81005 Recruiting
Chiba, Japan
Site JP81011 Recruiting
Fukuoka, Japan
Site JP81012 Recruiting
Fukuoka, Japan
Site JP81003 Recruiting
Nigata, Japan
Site JP81007 Recruiting
Osaka, Japan
Site JP81010 Recruiting
Tokushima, Japan
Korea, Republic of
Site KR82005 Recruiting
Daejeon, Korea, Republic of
Site KR82003 Recruiting
Seongnam-si, Korea, Republic of
Site KR82001 Recruiting
Seoul, Korea, Republic of
Site KR82002 Recruiting
Seoul, Korea, Republic of
Site KR82004 Recruiting
Seoul, Korea, Republic of
Netherlands
Site NL31001 Recruiting
Amsterdam, Netherlands
Spain
Site ES34003 Recruiting
Santander, Spain
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Seattle Genetics, Inc.
Investigators
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Study Director: Juan Pinelli, PA-C, MMSc Seattle Genetics, Inc.

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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT03219333     History of Changes
Other Study ID Numbers: SGN22E-001
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
Enfortumab vedotin
Metastatic Urothelial Cancer
ASG-22CE
Locally Advanced Urothelial Cancer
Antibody-Drug Conjugate
Nectin-4
Platinum-naïve
Cisplatin-ineligible
Antineoplastic Agents
Drug Therapy
ASG-22ME

Additional relevant MeSH terms:
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Neoplasms
Urinary Bladder Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Ureteral Neoplasms
Urethral Neoplasms
Pelvic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ureteral Diseases
Urethral Diseases