A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

348

Participants

Timeline

Start Date

October 11, 2017

Primary Completion Date

May 11, 2026

Study Completion Date

September 11, 2026

Conditions
Carcinoma, Transitional CellUrinary Bladder NeoplasmsUrologic NeoplasmsRenal Pelvis NeoplasmsUrothelial CancerUreteral NeoplasmsUrethral Neoplasms
Interventions
DRUG

enfortumab vedotin (EV)

Intravenous (IV) infusion on days 1 and 8 every 21 days

DRUG

pembrolizumab

IV infusion on day 1 every 21 days

DRUG

cisplatin

IV infusion on day 1 every 21 days

DRUG

carboplatin

IV infusion on day 1 every 21 days

DRUG

gemcitabine

IV infusion on days 1 and 8 every 21 days

Trial Locations (106)

10016

New York University (NYU) Cancer Institute, New York

10065

Weill Cornell Medical College, New York

10604

Memorial Sloan Kettering Cancer Center - Westchester, Harrison

11042

Northwell Cancer Center / Monter Cancer Center, Lake Success

11501

NYU Winthrop Hospital, Mineola

11553

Memorial Sloan Kettering Cancer Center - Nassau, Uniondale

11725

Memorial Sloan Kettering Cancer Center - Commack, Commack

12206

New York Oncology Hematology, P.C., Albany

13273

Site FR33004, Marseille

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester Medical Center, Rochester

15212

Allegheny General Hospital, Pittsburgh

17033

Penn State Milton S. Hershey Medical Center, Hershey

19008

CMOH Broomall, Broomall

19111

Fox Chase Cancer Center, Philadelphia

20007

Georgetown University Medical Center, Washington D.C.

20904

Maryland Oncology Hematology, P.A., Silver Spring

21000

Site FR33005, Dijon

22903

University of Virginia, Charlottesville

23502

Virginia Oncology Associates - Norfolk, Norfolk

27599

UNC Lineberger Comprehensive Cancer Center / University of North Carolina, Chapel Hill

27710

Duke University Medical Center, Durham

27834

Vidant Medical Center, Greenville

28033

Site ES34008, Madrid

28034

Site ES34001, Madrid

28041

Site ES34012, Madrid

28204

Levine Cancer Institute, Charlotte

29425

Medical University of South Carolina/Hollings Cancer Center, Charleston

29572

Carolina Urologic Research Center, Myrtle Beach

29607

Saint Francis Hospital Cancer Center, Greenville

30309

Piedmont Cancer Institute, Atlanta

30322

Winship Cancer Institute / Emory University School of Medicine, Atlanta

31008

Site ES34007, Pamplona

32224

Mayo Clinic Florida, Jacksonville

33000

Site FR33008, Bordeaux

33136

University of Miami, Miami

33308

Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center, Fort Lauderdale

33486

Boca Raton Regional Hospital / Lynn Cancer Institute, Boca Raton

37203

Tennessee Oncology / Sarah Cannon Research Institute, Nashville

37404

Sarah Cannon Research Institute, Chattanooga

39008

Site ES34004, Santander

39213

University of Mississippi Medical Center, Jackson

43623

Toledo Clinic Cancer Center, Toledo

44106

Case Western Reserve University / University Hospitals Case Medical Center, Cleveland

44718

Gabrail Cancer Center Research, LLC, Canton

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48202

Henry Ford Health System, Detroit

48910

McLaren Greater Lansing Hospital, Lansing

53226

Medical College of Wisconsin (Milwaukee), Milwaukee

54519

Site FR33010, Moselle

55455

University of Minnesota, Minneapolis

60115

Northwestern Medicine Cancer Center - Kishwaukee / Kishwaukee Cancer Center, DeKalb

60134

Northwestern Medicine Cancer Center Delnor, Geneva

60153

Cardinal Bernardin Cancer Center / Loyola University Medical Center, Maywood

60555

Northwestern Medicine Cancer Center - Warrenville / Central DuPage Hospital - Cancer Care, Warrenville

62526

Decatur Memorial Hospital - Illinois, Decatur

63110

Washington University School of Medicine - Siteman Cancer Center, St Louis

66205

University of Kansas Cancer Center, Westwood

67200

Site FR33001, Strasbourg

68506

Nebraska Hematology Oncology P.C., Lincoln

69008

Site FR33003, Lyon

69310

Site FR33006, Pierre-Bénite

70112

Tulane University Hospital and Clinic, New Orleans

70121

Ochsner Clinic Foundation, New Orleans

72703

Highlands Oncology Group, Fayetteville

75702

Texas Oncology - Tyler, Tyler

76104

Texas Oncology - Fort Worth Cancer Center, Fort Worth

78229

University of Texas Health Science Center at San Antonio, San Antonio

80012

Rocky Mountain Cancer Centers - Aurora, Aurora

84106

Utah Cancer Specialists, Salt Lake City

85054

Mayo Clinic Arizona, Phoenix

85234

Banner MD Anderson Cancer Center, Gilbert

85710

Arizona Oncology Associates, PC - HOPE, Tucson

87106

University of New Mexico Cancer Center, Albuquerque

89102

OptumCare Cancer Center, Las Vegas

90211

Tower Hematology Oncology Medical Group, Beverly Hills

91367

Kaiser Permanente Southern California, Woodland Hills

92093

UC San Diego / Moores Cancer Center, La Jolla

92868

University of California Irvine - Newport, Orange

94134

University of California at San Francisco, San Francisco

94305

Stanford Cancer Center / Blood & Marrow Transplant Program, Stanford

95403

Saint Joseph Heritage Medical Group, Santa Rosa

95817

University of California, Davis Comprehensive Cancer Center, Sacramento

99208

Medical Oncology Associates, Spokane

99503

Alaska Urological Institute, Anchorage

80045-0510

University of Colorado Hospital / University of Colorado, Aurora

06520

Yale Cancer Center, New Haven

06360

Eastern CT Hematology and Oncology Associates, Norwich

60637-1470

University of Chicago Medical Center, Chicago

02719

Southcoast Centers for Cancer Care - Fairhaven Site, Fairhaven

07920

Memorial Sloan Kettering Cancer Center - Basking Ridge, Basking Ridge

07601

Hackensack University Medical Center, Hackensack

07748

Memorial Sloan Kettering Cancer Center - Monmouth, Middletown

07645

Memorial Sloan Kettering Cancer Center - Bergen, Montvale

10087-9049

Memorial Sloan Kettering Cancer Center, New York

L6R 3J7

Site CA11008, East Brampton

K7L 2V7

Site CA11011, Kingston

M5G 2M9

Site CA11001, Toronto

H3T1E2

Site CA11005, Montreal

H4A3J1

Site CA11013, Montreal

J1H 5N4

Site CA11002, Sherbrooke

06189

Site FR33002, Nice

05100

Site IT39002, Terni

00935

Site PR78701, Rio Piedras

08041

Site ES34006, Barcelona

08208

Site ES34005, Sabadell

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Seagen Inc.

INDUSTRY

lead

Astellas Pharma Global Development, Inc.

INDUSTRY

NCT03288545 - A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer | Biotech Hunter | Biotech Hunter