A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer



Status:Recruiting
Conditions:Prostate Cancer, Prostate Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:October 8, 2017
End Date:May 2025
Contact:Seattle Genetics Trial Information Support
Email:clinicaltrials@seagen.com
Phone:866-333-7436

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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

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.

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.

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.
We found this trial at
52
sites
San Jose, California 94538
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Baltimore, Maryland 21231
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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433 Southwest 10th Street
Ocala, Florida 34471
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-5830
James P. Wilmot Cancer Center at University of Rochester Medical Center The Wilmot Cancer Center...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Albany, New York 12206
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Austin, Texas 78731
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Cleveland, Ohio 44195
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Davis, California 95616
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Greenville, South Carolina 29605
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Houston, Texas 77030
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Louisville, Kentucky 40207
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Newport Beach, California 92663
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Oakland, California 94611
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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5115 Centre Avenue
Pittsburgh, Pennsylvania 15232
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Roseville, California 95678
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6600 Bruceville Road
Sacramento, California 95823
(916) 688-2000
Kaiser Permanente - Sacramento At the Kaiser Permanente South Sacramento Medical Center, you and your...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Francisco, California 94115
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San Leandro, California 94577
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Santa Clara, California 95051
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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12210 Plum Orchard Drive
Silver Spring, Maryland 20902
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South San Francisco, California 94080
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Tualatin, Oregon 97062
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Villejuif-Cedex-France,
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Walnut Creek, California 94596
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