Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma

PHASE3CompletedINTERVENTIONAL
Enrollment

1,211

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

July 26, 2013

Study Completion Date

November 26, 2018

Conditions
High Risk Stage III Melanoma
Interventions
DRUG

ipilimumab

IV solution, IV, 10 mg/kg, 4x every 21 days, then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal

DRUG

Placebo

IV solution, IV, 10 mg/kg, 4x every 21 days then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal

Trial Locations (97)

2145

Local Institution, Westmead

2298

Local Institution, Waratah

3000

Local Institution, Leuven

3128

Local Institution, Box Hill

3144

Local Institution, Malvern

4102

Local Institution, Woolloongabba

4120

Local Institution, Greenslopes

5000

Local Institution, Odense C

6009

Local Institution, Nedlands

8000

Local Institution, Aarhus C

8091

Local Institution, Zurich

9000

Local Institution, Ghent

10065

Memorial Sloan Kettering Cancer Center, New York

10117

Local Institution, Berlin

12808

Local Institution, Prague

13885

Local Institution, Marseille

16132

Local Institution, Genova

18015

St Lukes Hospital And Health Network, Bethlehem

20141

Local Institution, Milan

20520

Local Institution, Turku

23538

Local Institution, Lübeck

24105

Local Institution, Kiel

28041

Local Institution, Madrid

28204

Levine Cancer Institute, Charlotte

33428

Boca Raton Comprehensive Cancer Center, Boca Raton

33612

H Lee Moffitt Cancer Cnt And Res Inst, Tampa

35128

Local Institution, Padua

37075

Local Institution, Göttingen

37232

Vanderbilt-Ingram Cancer Ctr, Nashville

45122

Local Institution, Essen

50009

Local Institution, Zaragoza

50937

Local Institution, Cologne

53100

Local Institution, Siena

54511

Local Institution, Vandœuvre-lès-Nancy

59037

Local Institution, Lillie

60068

Oncology Specialists, S.C., Park Ridge

63110

Washington University School Of Medicine, St Louis

68167

Local Institution, Mannheim

69120

Local Institution, Heidelberg

69495

Local Institution, Pierre-Bénite

72076

Local Institution, Tübingen

75010

Local Institution, Paris

75018

Local Institution, Paris

75230

Center For Oncology Research & Treatment, P.A., Dallas

80131

Local Institution, Napoli

84112

Huntsman Cancer Institute At The Univ. Of Utah, Salt Lake City

87131

University Of New Mexico Cancer Center, Albuquerque

89135

Nevada Cancer Center, Las Vegas

90025

The Angeles Clinic & Research Institute, Los Angeles

92104

Local Institution, Boulogne-Billancourt

92123

Sharp Memorial Hospital, San Diego

94115

California Pacific Medical Center, San Francisco

94117

North. Cal. Melanoma Center-St. Mary's Medical Center, San Francisco

94805

Local Institution, Villejuif

97080

Local Institution, Würzburg

98109

Seattle Cancer Care Alliance, Seattle

115478

Local Institution, Moscow

153013

Local Institution, Ivanovo

185007

Local Institution, Petrozavodsk

191104

Local Institution, Saint Petersburg

194044

Local Institution, Saint Petersburg

197022

Local Institution, Saint Petersburg

350040

Local Institution, Krasnodar

357502

Local Institution, Pyatigorsk

398005

Local Institution, Lipetsk

410004

Local Institution, Saratov

426009

Local Institution, Izhevsk

450054

Local Institution, Ufa

634050

Local Institution, Tomsk

660022

Local Institution, Krasnoyarsk

06520

Yale University School Of Medicine, New Haven

02215

Dana Farber Cancer Institute, Boston

07962

Atlantic Melanoma Center, Morristown

A-8036

Local Institution, Graz

A-1090

Local Institution, Vienna

T2N 4N2

Local Institution, Calgary

T6G 1Z2

Local Institution, Edmonton

H2W 1S6

Local Institution, Montreal

128 08

Local Institution, Prague

DK-2730

Local Institution, Herlev

00029

Local Institution, Helsinki

00144

Local Institution, Roma

1066 CX

Local Institution, Amsterdam

1081 BV

Local Institution, Amsterdam

2333 ZA

Local Institution, Leiden

6500 HB

Local Institution, Nijmegen

3075EA

Local Institution, Rotterdam

0310

Local Institution, Oslo

61-866

Local Institution, Poznan

02-781

Local Institution, Warsaw

08036

Local Institution, Barcelona

171 76

Local Institution, Stockholm

CM1 7ET

Local Institution, Chelmsford

SW17 0QT

Local Institution, London

SO16 6YD

Local Institution, Southampton

NG5 1PB

Local Institution, Nottingham

LS9 7TF

Local Institution, Leeds

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY