Spots Global Cancer Trial Database for A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
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Trial Identification
Brief Title: A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
Official Title: A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2
Study ID: NCT04879329
Conditions
Study Description
Brief Summary: This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
City of Hope, Duarte, California, United States
University of California Los Angeles Medical Center, Los Angeles, California, United States
University of California Irvine Medical Center, Orange, California, United States
Kaiser Permanente Southern California, Riverside, California, United States
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies, San Francisco, California, United States
University of Colorado Health Memorial Hospital, Colorado Springs, Colorado, United States
Florida Cancer Specialists - South Region, Fort Myers, Florida, United States
Florida Cancer Specialists - Panhandle, Tallahassee, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Florida Cancer Specialists - East West Palm Beach, FL (SCRI), West Palm Beach, Florida, United States
Northwest Georgia Oncology Centers, P.C., Marietta, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Henry Ford Health System, Detroit, Michigan, United States
Karmanos Cancer Institute / Wayne State University, Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan / Spectrum Health Butterworth Campus, Grand Rapids, Michigan, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
North Shore Center for Advanced Medicine Monter Cancer Center / North Shore University Hospital, Lake Success, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
University of Tennessee, Knoxville, Tennessee, United States
MD Anderson Cancer Center / University of Texas, Houston, Texas, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington, Seattle, Washington, United States
Medical College of Wisconsin (Milwaukee), Milwaukee, Wisconsin, United States
Centro de Oncologia e Investigacion de Buenos Aires (COIBA), Berazategui, Other, Argentina
Hospital Aleman (HA) Deutsches Hospital, Buenos Aires, Other, Argentina
Hospital Sirio Libanes, Caba, Other, Argentina
Instituto Alexander Fleming, Ciudad Autonoma Buenos Aires, Other, Argentina
Lyell McEwin Hospital, Elizabeth Vale, Other, Australia
Peninsula and South East Oncology, Frankston, Other, Australia
Mater Cancer Care Centre, South Brisbane, Other, Australia
Royal North Shore Hospital, St Leonards, Other, Australia
Princess Alexandra Hospital, Woolloongabba, Other, Australia
Macquarie University Hospital, New South Whales, , Australia
British Columbia Cancer Agency - Vancouver Centre, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Centre hospitalier universitaire de Sherbrooke (CHUS), Sherbrooke, Quebec, Canada
Centro de Estudios Clinicos IC La Serena Research, La Serena, Other, Chile
Pontificia Universidad Catolica De Chile Santiago, Santiago, Other, Chile
Instituto Oncologico Fundacion Arturo Lopez Perez (FALP), Santiago, Other, Chile
Rambam Health Corp., Haifa, Other, Israel
Rabin Medical Center, Petach Tikva, Other, Israel
Sheba Medical Center, Ramat Gan, Other, Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, Other, Israel
National Cancer Center Hospital East, Kashiwa-shi, Other, Japan
Osaka International Cancer Institute, Osaka, Other, Japan
Sapporo Medical University Hospital, Sapporo, Other, Japan
Osaka University Hospital, Suita-shi, Other, Japan
Tokushima University Hospital, Tokushima, Other, Japan
The Cancer Institute Hospital of JFCR, Tokyo, Other, Japan
The Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, Other, United Kingdom
Cambridge University Hospitals NHS Foundation Trust, Cambridge, Other, United Kingdom
NHS Greater Glasgow and Clyde (NHSGGC) - The Beatson West of Scotland Cancer Centre, Glasgow, Other, United Kingdom
Barts Health NHS Trust Saint Bartholomews Hospital, London, Other, United Kingdom
Contact Details
Name: Medical Monitor
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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