Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

886

Participants

Timeline

Start Date

March 30, 2020

Primary Completion Date

August 8, 2023

Study Completion Date

March 1, 2028

Conditions
Urothelial Cancer
Interventions
DRUG

Enfortumab vedotin

Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle

DRUG

Pembrolizumab

IV infusion on Day 1 of every 3-week cycle

DRUG

Cisplatin

administered as IV infusion on Day 1 of each 3-week cycle

DRUG

Carboplatin

Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle

DRUG

Gemcitabine

IV infusion on Days 1 and 8 of every 3 week cycle

Trial Locations (260)

333

Site TW88602, Kweishan

1083

Site HU36003, Budapest

1122

Site HU36002, Budapest

1200

Site BE32003, Brussels

2000

Site AR54001, Rosario

2109

Site AUS61002, Macquarie Park

3000

Site BE32007, Lueven

3010

Site CH41002, Bern

3084

Site AUS61004, Heidelberg

3128

Site AU61003, Box Hill

4000

Site BE32001, Liège

4031

Site CH41004, Basel

4032

Site HU36006, Debrecen

4101

Site AU61005, South Brisbane

4400

Site HU36001, Nyíregyháza

4814

Site AUS61001, Douglas

5004

Site HU36005, Szolnok

5112

Site AUS61006, South Australia

5300

Site AR54006, La Rioja

6100

Site TR90007, Ankara

6230

Site TR90009, Ankara

7000

Site CH41001, Chur

8200

Site DK45003, Aarhus N

8401

Site CH41003, Winterthur

8500

Site AR54003, Viedma

8800

Site BE32006, Roeselare

9000

Site BE32002, Ghent

9100

Site DK45001, Aalborg

10002

Site TW88605, Taipei

10016

New York University (NYU) Cancer Institute, New York

10029

Mount Sinai Medical Center, New York

10060

Site IT39008, Candiolo

10065

Memorial Sloan Kettering Cancer Center, New York

10117

Site DE49003, Berlin

10330

Site TH66004, Bangkok

10400

Site TH66003, Bangkok

Site TH66001, Ratchathewi

10408

Site KR82002, Goyang-si

10700

Site TH66006, Bangkok

11217

Site TW88601, Taipei

13605

Site KR82004, Seongnam-si

14004

Site ES34013, Córdoba

15232

Hillman Cancer Center / University of Pittsburgh Medical Center, Pittsburgh

16132

Site IT39006, Genova

20007

Lombardi Cancer Center / Georgetown University Medical Center, Washington D.C.

20132

Site IT39014, Milan

20141

Site IT39007, Milan

21231

Johns Hopkins Medical Center, Baltimore

22030

Site TR90004, Edirne

22908

University of Virginia, Charlottesville

23538

Site DE49001, Lübeck

26100

Site IT39009, Cremona

27003

Site ES34021, Lugo

27834

Vidant Medical Center, Greenville

28007

Site ES34018, Madrid

28034

Site ES34002, Madrid

28040

Site ES34003, Madrid

28041

Site ES34015, Madrid

29607

Saint Francis Hospital / Bon Secours - South Carolina, Greenville

30060

Georgia Cancer Specialists / Northside Hospital Cancer Institute, Marietta

30322

Winship Cancer Institute / Emory University School of Medicine, Atlanta

31008

Site ES34020, Pamplona

31096

Site IL97201, Haifa

33000

Site FR33014, Bordeaux

33611

Site DE49013, Bielefeld

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

34093

Site TR90008, Istanbul

34214

Site TR90003, Istanbul

37044

Site FR33017, Tours

37099

Site DE49015, Göttingen

37134

Site IT39001, Verona

38138

West Cancer Center & Research Institute, Germantown

39008

Site ES34012, Santander

39120

Site DE49008, Magdeburg

40002

Site TH66007, Muang

40225

Site DE49016, Düsseldorf

40447

Site TW88607, Taichung

40705

Site TW88606, Taichung

41013

Site ES34007, Seville

42080

Site TR90001, Konya

43623

Toledo Clinic Cancer Center, Toledo

44195

The Cleveland Clinic, Cleveland

44280

Site TR90006, Malatya

44281

Site IL97202, Kfar Saba

44649

Site DE49009, Herne

45147

Site DE49011, Essen

46009

Site ES34019, Valencia

46014

Site ES34009, Valencia

47014

Site IT39003, Meldola

49414

Site IL97208, Petah Tikva

50200

Site TH66005, Chiang Mai

52100

Site IT39005, Areezo

52621

Site IL97204, Tel Litwinsky

56126

Site IT39004, Pisa

58100

Site IL97209, Holon

60126

Site IT39011, Torrette

60488

Site DE49007, Frankfurt am Main

64239

Site IL97210, Tel Aviv

67200

Site FR33013, Strasbourg

68167

Site DE49012, Mannheim

69120

Site DE49005, Heidelberg

69373

Site FR33016, Lyon

69495

Site FR33020, Pierre-Bénite

70006

Louisiana State University/ East Jefferson General Hospital, Metairie

70300

Site IL97205, Ẕerifin

70403

Site TW88604, Tainan City

72076

Site DE49004, Tübingen

75390

University of Texas Southwestern Medical Center, Dallas

75701

UT Health East Texas Hope Cancer Center, Tyler

76100

Site IL97211, Rehovot

80012

Rocky Mountain Cancer Centers - Aurora, Aurora

80045

University of Colorado Hospital / University of Colorado, Aurora

80218

Cancer Centers of Colorado - Denver, Denver

81450

Site TR90002, Istanbul

81675

Site DE49002, München

83301

Site TW88603, Kaohsiung City

84101

Site IL97203, Beersheba

84112

Huntsman Cancer Institute, Salt Lake City

85224

Ironwood Cancer & Research Centers - Chandler, Chandler

85710

Arizona Oncology Associates PD - HOPE, Tucson

87109

New Mexico Cancer Center, Albuquerque

89081

Site DE49010, Ulm

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

90095

University of California Los Angeles Medical Center, Los Angeles

90110

Site TH66002, Hat Yai

91010

City of Hope National Medical Center, Duarte

91054

Site DE49014, Erlangen

91120

Site IL97206, Jerusalem

91505

Providence St Joseph Medical Center, Burbank

92868

University of California Irvine - Newport, Orange

94805

Site FR33011, Villejuif-Cedex-France

98109

Seattle Cancer Care Alliance / University of Washington, Seattle

100021

Site CN86009, Beijing

100034

Site CN86030, Xicheng District

100036

Site CN86001, Beijing

100050

Site CN86004, Beijing

100191

Site CN86005, Beijing

105077

Site RU70004, Moscow

110022

Site CN86011, Shenyang

119074

Site SG65001, Singapore

123056

Site RU70011, Moscow

125284

Site RU70003, Moscow

130021

Site CN86003, Changchun

153040

Site RU70020, Ivanovo

163045

Site RU70016, Arkhangelsk

169610

Site SG65002, Singapore

188663

Site RU70006, Leningradskaya Oblast'

195271

Site RU70010, Saint Petersburg

197082

Site RU70007, Saint Petersburg

197758

Site RU70008, Saint Petersburg

Site RU70012, Saint Petersburg

200040

Site CN86014, Shanghai

210008

Site CN86017, Nanjing

210029

Site CN86012, Nanjing

221009

Site CN86026, Xuzhou

233000

Site CN86015, Bengbu

250021

Site CN86027, Jinan

300052

Site CN86023, Tianjin

308433

Site SG65003, Singapore

310014

Site CN86013, Hangzhou

310016

Site CN86022, Hangzhou

315016

Site CN86021, Ningbo

325000

Site CN86029, Wenzhou

350005

Site CN86028, Fuzhou

357502

Site RU70019, Pyatigorsk

400030

Site CN86024, Chongqing

Site CN86025, Hefei

400038

Site CN86007, Chongqing

410013

Site CN86006, Changsha

Site CN86016, Changsha

430030

Site CN86008, Wuhan

430032

Site RU70009, Saransk

450000

Site RU70005, Ufa

453000

Site CN86019, Tianjin

510120

Site CN86002, Guangzhou

510280

Site CN86020, Gunagzhou

603074

Site RU70017, Nizhny Novgorod

610041

Site CN86010, Chengdu

625041

Site RU70015, Tyumen

644013

Site RU70002, Omsk

656049

Site RU70013, Barnaul

660133

Site RU70014, Krasnoyarsk

06520

Yale Cancer Center, New Haven

06360

Eastern CT Hematology and Oncology Associates, Norwich

04046

Maine Health Cancer Care, Biddeford

C1019ABS

Site AR54008, Buenos Aire

C1426ANZ

Site AR54011, CABA

X5004FHP

Site AR54005, Córdoba

M5500AYB

Site AR54004, Mendoza

T400GTB

Site AR54002, San Miguel

T4000IAK

Site AR54012, San Miguel de Tucumán

T2N 4N2

Site CA11004, Calgary

T6G 1Z2

Site CA11003, Edmonton

V5Z 4E6

Site CA11006, Vancouver

L8V 1C3

Site CA11002, Hamilton

N6A 5A5

Site CA11009, London

L1G 2B9

Site CA11011, Oshawa

M4N 3M5

Site CA11012, Toronto

M5G 2M9

Site CA11005, Toronto

H2X 0A9

Site CA11010, Montreal

H3T 1E2

Site CA11001, Montreal

G1R 2J6

Site CA11008, Québec

0571

Site CN86018, Hangzhou

656 91

Site CZ42006, Brno

500 05

Site CZ42001, Hradec Králové

779 00

Site CZ42004, Olomouc

140 59

Site CZ42005, Praha 4-Krc

06189

Site FR33003, Nice

07747

Site DE49006, Jena

05100

Site IT39002, Terni

Unknown

Site JP81002, Bunkyō City

Site JP81009, Chiba

Site JP81018, Chiba

Site JP81013, Fukuoka

Site JP81020, Fukuoka

Site JP81011, Hirosaki

Site JP81006, Kawasaki-shi

Site JP81001, Kōtoku

Site JP81017, Kyoto

Site JP81015, Niigata

Site JP81005, Okayama

Site JP81008, Osaka

Site JP81016, Osakasayama-Shi

Site JP81007, Sapporo

Site JP81012, Sendai

Site JP81014, Tokushima

Site JP81019, Tokyo

Site JP81003, Toyama

Site JP81004, Tsukuba

Site JP81010, Ube

1066 CX

Site NL31002, Amsterdam

Site NL31005, Amsterdam, Noord-Holland

1081 HV

Site NL31001, Amsterdam

8934 AD

Site NL31007, Leeuwarden

3435 CM

Site NL31004, Nieuwegein

3075 EA

Site NL31003, Rotterdam

3584 CX

Site NL31006, Utrecht

01-748

Site PL48002, Warsaw

301-721

Site KR82001, Daejeon

519-763

Site KR82008, Hwasun

03722

Site KR82003, Seoul

05505

Site KR82005, Seoul

135-710

Site KR82007, Seoul

137-701

Site KR82006, Seoul

08003

Site ES34017, Barcelona

08035

Site ES34010, Barcelona

08036

Site ES34006, Barcelona

08041

Site ES34001, Barcelona

08907

Site ES34008, Barcelona

08243

Site ES34004, Manresa

08208

Site ES34016, Sabadell

07059

Site TR90005, Antalya

G12 0YN

Site UK44005, Glasgow

EC1M 6BQ

Site UK44001, London

W6 8RF

Site UK44009, London

OX3 7LE

Site UK44006, Oxford

PL6 8DH

Site UK44010, Plymouth

PR2 9HT

Site UK44002, Preston

S10 2RX

Site UK44003, Sheffield

SO16 6YD

Site UK44008, Southampton

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Seagen Inc.

INDUSTRY

lead

Astellas Pharma Global Development, Inc.

INDUSTRY