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.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | October 8, 2017 | Phase 2 | Interventional |
Primary Outcome 1 - Measure: Objective response rate (ORR) by an independent review facility (IRF)
Primary Outcome 1 - Time Frame: Up to 3 years
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.
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Anne-Sophie Carret, MD
Role: Study Director
Affiliation: Seattle Genetics, Inc.
Name: Seattle Genetics Trial Information Support
Phone: 866-333-7436
Email: clinicaltrials@seagen.com
Facility | Status | Contact |
---|---|---|
Alaska Urological Institute Anchorage, Alaska 99503 United States |
Recruiting | |
Arizona Oncology Associates, PC - HAL Phoenix, Arizona 85016 United States |
Recruiting | |
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 |
Completed | |
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida 33612 United States |
Recruiting | |
Augusta University Augusta, Georgia 30912 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 DE49004 Muenster, Germany |
Recruiting | |
Site DE49001 Tübingen, Germany |
Recruiting | |
Site IT39001 Milano, Italy |
Recruiting | |
Site IT39003 Terni, Italy |
Recruiting | |
Site JP81001 Hirosaki, Aomori Japan |
Recruiting | |
Site JP81004 Tsukuba, Ibaraki Japan |
Recruiting | |
Site JP81002 Morioka, Iwate Japan |
Recruiting | |
Site JP81008 Osakasayama, Osaka Japan |
Recruiting | |
Site JP81006 Shinjuku-ku, Tokyo Japan |
Recruiting | |
Site JP81009 Ube, Yamaguchi Japan |
Recruiting | |
Site JP81005 Chiba, Japan |
Recruiting | |
Site JP81011 Fukuoka, Japan |
Recruiting | |
Site JP81012 Fukuoka, Japan |
Completed | |
Site JP81003 Nigata, Japan |
Recruiting | |
Site JP81007 Osaka, Japan |
Completed | |
Site JP81010 Tokushima, Japan |
Recruiting | |
Site KR82005 Daejeon, Korea, Republic of |
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 NL31001 Amsterdam, Netherlands |
Recruiting | |
Site ES34002 Barcelona, Spain |
Recruiting | |
Site ES34003 Santander, Spain |
Recruiting | |
Site ES34004 Sevilla, Spain |
Recruiting |