Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,314

Participants

Timeline

Start Date

March 24, 2017

Primary Completion Date

August 30, 2024

Study Completion Date

November 24, 2025

Conditions
Urothelial Cancer
Interventions
BIOLOGICAL

Nivolumab

Specified Dose on Specified Days

BIOLOGICAL

Ipilimumab

Specified Dose on Specified Days

DRUG

Gemcitabine

Specified Dose on Specified Days

DRUG

Cisplatin

Specified Dose on Specified Days

DRUG

Carboplatin

Specified Dose on Specified Days

Trial Locations (174)

0

Local Institution - 0106, Vitacura

Local Institution - 0175, Nanjing

Local Institution - 0173, Hangzhou

34

Local Institution - 0030, Lima

100

Local Institution - 0158, Taipei

333

Local Institution - 0157, Taoyuan District

833

Local Institution - 0156, Kaohsiung City

1120

Local Institution - 0009, Buenos Aires

1426

Local Institution - 0005, Capital Federal

1478

Local Institution - 0081, Lorenskog

2145

Local Institution - 0099, Westmead

2298

Local Institution - 0096, Waratah

2730

Local Institution - 0196, Herlev

3084

Local Institution - 0101, Heidelberg

4101

Local Institution - 0188, South Brisbane

4224

Local Institution - 0120, Tugun

5000

Local Institution - 0134, Córdoba

5004

Local Institution - 0006, Córdoba

5021

Local Institution - 0074, Bergen

5404

Local Institution - 0061, Baden

6018

Local Institution - 0100, Doubleview

7000

Local Institution - 0042, Chur

7600

Local Institution - 0007, Mar del Plata

8500

Local Institution - 0008, Viedma

9210

Local Institution - 0190, Aalborg

10029

Local Institution - 0072, New York

10408

Local Institution - 0125, Goyang-si

11217

Local Institution - 0155, Taipei

11501

Local Institution - 0014, Mineola

13273

Local Institution - 0088, Marseille

13620

Local Institution - 0126, Seongnam-si

14080

Local Institution - 0130, Tlalpan

14263

Local Institution - 0083, Buffalo

15006

Local Institution - 0070, A Coruña

15076

Local Institution - 0031, Lima

15212

Local Institution - 0013, Pittsburgh

20133

Local Institution - 0107, Milan

22763

Local Institution - 0049, Hamburg

27710

Local Institution - 0116, Durham

28034

Local Institution - 0065, Madrid

28041

Local Institution - 0066, Madrid

30029

Local Institution - 0091, Nîmes

30607

Local Institution - 0004, Athens

30625

Local Institution - 0037, Hanover

31792

Local Institution - 0033, Thomasville

32256

Local Institution - 0062, Jacksonville

33308

Local Institution - 0087, Fort Lauderdale

33486

Local Institution - 0051, Boca Raton

34300

Local Institution - 0204, Istanbul

35340

Local Institution - 0193, Izmir

37044

Local Institution - 0093, Tours

39008

Local Institution - 0209, Santander

39401

Hattiesburg Clinic, Hattiesburg

40705

Local Institution - 0159, Taichung

41013

Local Institution - 0067, Seville

42271

Local Institution - 0090, Saint-Priest-en-Jarez

43210

Local Institution - 0082, Columbus

44281

Local Institution - 0199, Kfar Saba

45147

Local Institution - 0048, Essen

46009

Local Institution - 0069, Valencia

47014

Local Institution - 0111, Forlì

48018

Local Institution - 0197, Faenza

48197

Local Institution - 0063, Ann Arbor

52100

Local Institution - 0108, Arezzo

52621

Local Institution - 0198, Ramat Gan

55337

Local Institution - 0002, Burnsville

58100

Local Institution - 0109, Grosseto

59000

Local Institution - 0089, Lille

60612

Local Institution - 0046, Chicago

63110

Local Institution - 0095, St Louis

64460

Local Institution - 0131, Monterrey

68167

Local Institution - 0213, Mannheim

70121

Local Institution - 0117, New Orleans

72076

Local Institution - 0040, Tübingen

79106

Local Institution - 0047, Freiburg im Breisgau

80131

Local Institution - 0110, Napoli

87131

Local Institution - 0084, Albuquerque

90419

Local Institution - 0038, Nuremberg

92151

Local Institution - 0092, Suresnes

92637

Local Institution - 0114, Weiden

93703

Local Institution - 0115, Fresno

94805

Local Institution - 0094, Villejuif

95403

St Joseph Heritage Healthcare, Santa Rosa

97080

Local Institution - 0039, Würzburg

97213

Local Institution - 0104, Portland

98034

Local Institution - 0086, Kirkland

99503

Local Institution - 0001, Anchorage

100001

Local Institution - 0171, Beijing

100034

Local Institution - 0169, Beijing

100083

Local Institution - 0170, Beijing

125367

Local Institution, Moscow

130021

Local Institution - 0186, Changchun

150000

Local Institution - 0219, Harbin

168583

Local Institution - 0192, Singapore

200025

Local Institution - 0167, Shanghai

200032

Local Institution - 0162, Shanghai

Local Institution - 0164, Shanghai

200040

Local Institution - 0163, Shanghai

200542

Local Institution - 0187, Craiova

210000

Local Institution - 0177, Nanjing

210008

Local Institution - 0176, Nanjing

264000

Local Institution - 0216, Yantai

310009

Local Institution - 0174, Hangzhou

310014

Local Institution - 0172, Hangzhou

400015

Local Institution - 0191, Cluj-Napoca

400030

Local Institution - 0182, Chongqing

430030

Local Institution - 0180, Wuhan

550002

Local Institution - 0217, Guiyang

610041

Local Institution - 0184, Chengdu

1138519

Local Institution - 0148, Bunkyo-ku

1138602

Local Institution - 0142, Bunkyo-ku

1168567

Local Institution - 0149, Adachi-ku

1608582

Local Institution - 0138, Shinjuku-Ku

2520598

Local Institution - 0012, Viña del Mar

3058576

Local Institution - 0150, Tsukuba

5418567

Local Institution - 0144, Osaka

5698686

Local Institution - 0145, Takatsuki-shi

7008558

Local Institution - 0143, Okayama

7610793

Local Institution - 0137, Kita-Gun

7910280

Local Institution - 0147, Matsuyama

8128582

Local Institution - 0140, Fukuoka

8420383

Local Institution - 0010, Santiago

9518520

Local Institution - 0141, Niigata

90610000

Local Institution - 0020, Porto Alegre

02210

Local Institution - 0056, Boston

02215

Local Institution - 0073, Boston

Local Institution - 0208, Boston

01757

Local Institution - 0207, Milford

64111-3220

Local Institution - 0032, Kansas City

03103

Local Institution - 0057, Manchester

70200-730

Local Institution - 0017, Brasília

98700-000

Local Institution - 0021, Ijuí

99010-080

Local Institution - 0119, Passo Fundo

88034-000

Local Institution - 0016, Florianópolis

14784-400

Local Institution - 0018, Barretos

15090-000

Local Institution - 0019, São José do Rio Preto

B3H 2Y9

Local Institution - 0053, Halifax

N6A 4L6

Local Institution - 0064, London

G1J 1Z4

Local Institution - 0054, Québec

J1H 5N4

Local Institution - 0052, Sherbrooke

030001

Local Institution - 0220, Taiyuan

656 53

Local Institution - 0160, Brno

500 05

Local Institution - 0152, Hradec Králové

00029

Local Institution - 0060, Helsinki

01307

Local Institution - 0036, Dresden

07747

Local Institution - 0041, Jena

115 28

Local Institution - 0102, Athens

455 00

Local Institution - 0103, Ioannina

036-8563

Local Institution - 0136, Hirosaki

260-8717

Local Institution - 0135, Chiba

0608543

Local Institution - 0146, Sapporo

0208505

Local Institution - 0214, Morioka

589-8511

Local Institution - 0139, Sayama

431-3192

Local Institution - 0201, Hamamatasu

641-8510

Local Institution - 0215, Wakayama

755-8505

Local Institution - 0200, Ube

06100

Local Institution - 0129, Mexico City

07760

Local Institution - 0154, Mexico City

1066 CX

Local Institution - 0022, Amsterdam

7512KZ

Local Institution - 0055, Enschede

9713 GZ

Local Institution - 0024, Groningen

8934 AD

Local Institution - 0026, Leeuwarden

85-796

Local Institution - 0189, Bydgoszcz

75-581

Local Institution - 0205, Koszalin

02-781

Local Institution - 0202, Warsaw

03080

Local Institution - 0124, Seoul

03722

Local Institution - 0151, Seoul

05505

Local Institution - 0128, Seoul

06351

Local Institution - 0127, Seoul

08025

Local Institution - 0068, Barcelona

553 05

Local Institution - 0075, Jönköping

581 85

Local Institution - 0059, Linköping

221 85

Local Institution - 0058, Lund

06590

Local Institution - 0194, Ankara

Sponsors
All Listed Sponsors
collaborator

Ono Pharmaceutical Co. Ltd

INDUSTRY

lead

Bristol-Myers Squibb

INDUSTRY