A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

PHASE3TerminatedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

January 15, 2020

Primary Completion Date

October 31, 2023

Study Completion Date

October 31, 2023

Conditions
Urinary Bladder Neoplasms
Interventions
DRUG

nivolumab

Specified Dose on Specified Days

OTHER

Placebo

Specified Dose on Specified Days

BIOLOGICAL

Bacillus Calmette-Guérin (BCG)

Specified Dose on Specified Days

Trial Locations (63)

0

Local Institution - 0010, Recoleta

1090

Local Institution - 0099, Vienna

1120

Local Institution - 0080, Buenos Aires

1419

Local Institution - 0088, Capital Federal

1426

Local Institution - 0009, Caba

1431

Local Institution - 0016, Ciudad Autonoma Beunos Aires

2050

Local Institution - 0002, Sydney

2576

Local Institution - 0114, Bowral

4010

Local Institution - 0097, Linz

4012

Local Institution - 0001, Woolloongabba

4600

Local Institution - 0098, Wels

5000

Local Institution - 0107, Córdoba

5020

Local Institution - 0104, Salzburger

7600

Local Institution - 0081, Mar del Plata

8500

Local Institution - 0008, Viedma

10126

Local Institution - 0067, Torino

10461

Local Institution - 0084, The Bronx

12462

Local Institution - 0031, Haidari

13385

Local Institution - 0108, Marseille

20133

Local Institution - 0062, Milan

21079

Local Institution - 0106, Dijon

28041

Local Institution - 0055, Madrid

31008

Local Institution - 0096, Pamplona

39008

Local Institution - 0057, Santander

41124

Local Institution - 0063, Modena

42100

Local Institution - 0065, Reggio Emilia

44625

Local Institution - 0094, Herne

46010

Local Institution - 0058, Valencia

49933

Local Institution - 0042, Angers

50968

Local Institution - 0105, Cologne

52621

Local Institution - 0074, Ramat Gan

54292

Local Institution - 0095, Trier

57001

Local Institution - 0032, Thessaloniki

59000

Local Institution - 0045, Lille

60637

The University Of Chicago, Chicago

75018

Local Institution - 0111, Paris

75679

Local Institution - 0103, Paris

80131

Local Institution - 0064, Napoli

94800

Local Institution - 0040, Villejuif

121309

Local Institution - 0051, Moscow

199034

Local Institution - 0052, Saint Petersburg

1720430

Local Institution - 0011, La Serena

2520598

Local Institution - 0072, Viña del Mar

6423906

Local Institution - 0075, Tel Aviv

9103102

Local Institution - 0073, Jerusalem

38408-150

Local Institution - 0050, Uberlândia

90035-001

Local Institution - 0048, Porto Alegre

88301-220

Local Institution - 0047, Itajaí

22793-080

Local Institution - 0049, Rio de Janeiro

M5G 1Z5

Local Institution - 0017, Toronto

H2X 0C2

Local Institution - 0038, Montreal

H3T 1E2

Local Institution - 0037, Montreal

G5L 5T1

Local Institution - 0012, Rimouski

FR-67091

Local Institution - 0041, Strasbourg

07747

Local Institution - 0093, Jena

00168

Local Institution - 0066, Roma

6815 AD

Local Institution - 0054, Arnhem

3015 GD

Local Institution, Rotterdam

06006

Local Institution - 0061, Badajoz

08916

Local Institution - 0060, Badalona-barcelona

08208

Local Institution - 0059, Sabadell

601 82

Local Institution - 0087, Norrköping

901 85

Local Institution - 0083, Umeå

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY