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BRIEF 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

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


  • Org Study ID: SGN22E-001
  • Secondary ID:
  • NCT ID: NCT03219333
  • NCT Alias:
  • Sponsor: Astellas Pharma Global Development, Inc. - Industry
  • Source: Astellas Pharma 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.

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.

Overal Status Start Date Phase Study Type
Recruiting September 20, 2017 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Objective response rate (ORR) by an independent review facility (IRF)

Primary Outcome 1 - Time Frame: Up to 3 years

Condition:

  • Carcinoma, Transitional Cell
  • Urinary Bladder Neoplasms
  • Urologic Neoplasms
  • Renal Pelvis Neoplasms
  • Urothelial Cancer
  • Ureteral Neoplasms
  • Urethral Neoplasms

Eligibility

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 0 or 1.

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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Juan Pinelli, PA-C, MMSc

Role: Study Director

Affiliation: Seattle Genetics, Inc.

Overall Contact

Name: Seattle Genetics Trial Information Support

Phone: 866-333-7436

Email: clinicaltrials@seagen.com

Locations

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