Spots Global Cancer Trial Database for A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer
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Trial Identification
Brief Title: A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer
Official Title: A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer
Study ID: NCT03288545
Study Description
Brief Summary: This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra. Some parts of the study will look at locally advanced or metastatic urothelial cancer (la/mUC), which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at an earlier stage that has spread into the muscle wall of the bladder. This study will look at the side effects of enfortumab vedotin alone and with other anticancer therapies. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.
Detailed Description: This study will examine the safety and anticancer activity of enfortumab vedotin (EV) given intravenously as monotherapy and in combination with other anticancer therapies as first line (1L) and second line (2L) treatment for patients with urothelial cancer. The primary goal of the study is to determine the safety, tolerability, and efficacy of enfortumab vedotin alone and in combination with pembrolizumab and/or chemotherapy. The study will be conducted in multiple parts: Locally advanced or metastatic urothelial cancer: * Dose escalation * Expansion * Part 1: Cohorts A and Optional B * Part 2: Cohorts D, E, and Optional F * Part 3: Cohort G. * Randomized Cohort K * EV Monotherapy Arm * EV Combination Arm Muscle invasive bladder cancer: * Cohort H * Optional Cohort J * Cohort L
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Urological Institute, Anchorage, Alaska, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Mayo Clinic Arizona, Phoenix, Arizona, United States
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States
Highlands Oncology Group, Fayetteville, Arkansas, United States
Tower Hematology Oncology Medical Group, Beverly Hills, California, United States
UC San Diego / Moores Cancer Center, La Jolla, California, United States
University of California Irvine - Newport, Orange, California, United States
University of California, Davis Comprehensive Cancer Center, Sacramento, California, United States
University of California at San Francisco, San Francisco, California, United States
Saint Joseph Heritage Medical Group, Santa Rosa, California, United States
Stanford Cancer Center / Blood & Marrow Transplant Program, Stanford, California, United States
Kaiser Permanente Southern California, Woodland Hills, California, United States
Rocky Mountain Cancer Centers - Aurora, Aurora, Colorado, United States
University of Colorado Hospital / University of Colorado, Aurora, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
Eastern CT Hematology and Oncology Associates, Norwich, Connecticut, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Boca Raton Regional Hospital / Lynn Cancer Institute, Boca Raton, Florida, United States
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center, Fort Lauderdale, Florida, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
University of Miami, Miami, Florida, United States
Piedmont Cancer Institute, Atlanta, Georgia, United States
Winship Cancer Institute / Emory University School of Medicine, Atlanta, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Decatur Memorial Hospital - Illinois, Decatur, Illinois, United States
Northwestern Medicine Cancer Center - Kishwaukee / Kishwaukee Cancer Center, DeKalb, Illinois, United States
Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center, Maywood, Illinois, United States
Northwestern Medicine Cancer Center - Warrenville / Central DuPage Hospital - Cancer Care, Warrenville, Illinois, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Tulane University Hospital and Clinic, New Orleans, Louisiana, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Maryland Oncology Hematology, P.A., Silver Spring, Maryland, United States
Southcoast Centers for Cancer Care - Fairhaven Site, Fairhaven, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
McLaren Greater Lansing Hospital, Lansing, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States
Nebraska Hematology Oncology P.C., Lincoln, Nebraska, United States
OptumCare Cancer Center, Las Vegas, Nevada, United States
Memorial Sloan Kettering Cancer Center - Basking Ridge, Basking Ridge, New Jersey, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center - Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center - Bergen, Montvale, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
New York Oncology Hematology, P.C., Albany, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center - Commack, Commack, New York, United States
Memorial Sloan Kettering Cancer Center - Westchester, Harrison, New York, United States
Northwell Cancer Center / Monter Cancer Center, Lake Success, New York, United States
NYU Winthrop Hospital, Mineola, New York, United States
New York University (NYU) Cancer Institute, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Memorial Sloan Kettering Cancer Center - Nassau, Uniondale, New York, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina, Chapel Hill, North Carolina, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Vidant Medical Center, Greenville, North Carolina, United States
Gabrail Cancer Center Research, LLC, Canton, Ohio, United States
Case Western Reserve University / University Hospitals Case Medical Center, Cleveland, Ohio, United States
Toledo Clinic Cancer Center, Toledo, Ohio, United States
CMOH Broomall, Broomall, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina/Hollings Cancer Center, Charleston, South Carolina, United States
Saint Francis Hospital Cancer Center, Greenville, South Carolina, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Sarah Cannon Research Institute, Chattanooga, Tennessee, United States
Tennessee Oncology / Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology - Fort Worth Cancer Center, Fort Worth, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Texas Oncology - Tyler, Tyler, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
University of Virginia, Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk, Norfolk, Virginia, United States
Medical Oncology Associates, Spokane, Washington, United States
Medical College of Wisconsin (Milwaukee), Milwaukee, Wisconsin, United States
Site CA11008, East Brampton, Ontario, Canada
Site CA11011, Kingston, Ontario, Canada
Site CA11001, Toronto, Ontario, Canada
Site CA11005, Montreal, Quebec, Canada
Site CA11013, Montreal, Quebec, Canada
Site CA11002, Sherbrooke, Quebec, Canada
Site FR33008, Bordeaux, , France
Site FR33005, Dijon, , France
Site FR33003, Lyon, , France
Site FR33004, Marseilles, , France
Site FR33010, Moselle, , France
Site FR33002, Nice Cedex, , France
Site FR33006, Pierre-Benite, , France
Site FR33001, Strasbourg, , France
Site IT39002, Terni, , Italy
Site PR78701, Rio Piedras, , Puerto Rico
Site ES34006, Barcelona, , Spain
Site ES34008, Madrid, , Spain
Site ES34001, Madrid, , Spain
Site ES34012, Madrid, , Spain
Site ES34007, Pamplona, , Spain
Site ES34005, Sabadell, , Spain
Site ES34004, Santander, , Spain
Contact Details
Name: Changting Meng, MD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
Name: Jason Lukas, MD, PhD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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