Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

PHASE3CompletedINTERVENTIONAL
Enrollment

681

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

January 31, 2011

Study Completion Date

October 31, 2013

Conditions
Melanoma
Interventions
DRUG

Ipilimumab

"Intravenous solution; intravenous; 10mg/kg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24, until disease progression, unacceptable toxicity or withdrawal of consent~In Maintenance phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression"

DRUG

Placebo

Intravenous solution; intravenous; 0 mg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24; until disease progression, unacceptable toxicity or withdrawal of consent

DRUG

Dacarbazine

Intravenous solution; intravenous; 850 mg/m\^2; one dose every 3 weeks for 22 weeks, until disease progression, unacceptable toxicity or withdrawal of consent

Trial Locations (127)

1081

Local Institution, Hv Amsterdam

1090

Local Institution, Vienna

1185

Local Institution, Buenos Aires

1200

Local Institution, Brussels

1211

Local Institution, Geneva

2196

Local Institution, Saxonworld

2199

Local Institution, Johannesburg

2300

Local Institution, Newcastle

2444

Local Institution, Port Macquarie

2450

Local Institution, Coffs Harbour

2930

Local Institution, Brasschaat

3128

Local Institution, Box Hill

4101

Local Institution, South Brisbane

6000

Local Institution, Port Elizabeth

7400

Local Institution, Kaposyar

7570

Local Institution, Cape Town

9000

Local Institution, Ghent

10065

Memorial Sloan Kettering Cancer Center, New York

12200

Local Institution, Berlin

13009

Local Institution, Marseille

16128

Local Institution, Genova

18009

Local Institution, Cherkassy

18015

St. Luke'S Hospital & Health Network, Bethlehem

20141

Local Institution, Milan

21204

Greater Baltimore Medical Center, Baltimore

21215

Sinai Hospital Of Baltimore, Baltimore

23226

Virginia Cancer Institute, Richmond

24105

Local Institution, Kiel

28204

Blumenthal Cancer Center, Charlotte

29200

Local Institution, Brest

29464

Lowcountry Hematology & Oncology, Pa, Mt. Pleasant

32256

Cancer Specialists Of North Florida Beaches, Jacksonville

32806

Orlando Health, Inc. M.D. Anderson Cancer Center Orlando, Orlando

33075

Local Institution, Bordeaux

34952

Hematology Oncology Associates Of The Treasure Coast, Port Saint Lucie

35128

Local Institution, Padua

37232

Vanderbilt-Ingram Cancer Ctr, Nashville

37916

Thompson Cancer Survival Center, Knoxville

38320

Local Institution, Canarias

41701

Kentucky Cancer Clinic, Hazard

42055

Local Institution, Saint-Etienne

44093

Local Institution, Nantes

46014

Local Institution, Valencia

46037

Central Indiana Cancer Centers, Fishers

46202

Indiana University Cancer Center, Indianapolis

49044

Local Institution, Dnipro

50009

Local Institution, Zaragoza

53100

Local Institution, Siena

60068

Oncology Specialists, Sc, Park Ridge

60637

University Of Chicago, Chicago

61761

Mid-Illinois Hematology/Oncology Associates, Ltd., Normal

64239

Local Institution, Tel Aviv

64507

St Joseph Oncology Inc, Saint Joseph

65203

Ellis Fischel Cancer Center, Columbia

67502

Hutchinson Clinic, Pa, Hutchinson

68167

Local Institution, Mannheim

69120

Local Institution, Heidelberg

69495

Local Institution, Pierre-Bénite

72076

Local Institution, Tübingen

75010

Local Institution, Paris

79031

Local Institution, Lviv

79410

Joe Arrington Cancer Research And Treatment Center, Lubbock

80131

Local Institution, Napoli

81675

Local Institution, München

87106

University Of New Mexico Cancer Center, Albuquerque

88000

Local Institution, Uzhhorod

90025

The Angeles Clinic And Research Institute, Los Angeles

91120

Local Institution, Jerusalem

91750

Wilshire Oncology Medical Group Inc, La Verne

92123

Sharp Clinical Oncology Research, San Diego

92262

Comprehensive Cancer Center, Palm Springs

92801

Pacific Cancer Medical Center, Anaheim

94805

Local Institution, Villejuif

97080

Local Institution, Wurzburg

97100

Local Institution, Ragusa

97213

Providence Portland Medical Center, Portland

105229

Local Institution, Moscow

115478

Local Institution, Moscow

183047

Local Institution, Murmansk

191104

Local Institution, Saint Petersburg

198255

Local Institution, Saint Petersburg

355047

Local Institution, Stavropol

357502

Local Institution, Pyatigorsk

390011

Local Institution, Ryazan

443066

Local Institution, Samara

06105

Saint Francis Hospital And Medical Center, Hartford

06902-3628

Hematology Oncology, P.C., Stamford

02115

Dana Farber Cancer Institute, Boston

C1408INH

Local Institution, Buenos Aires

C1426ANZ

Local Institution, Buenos Aires

X5000AAI

Local Institution, Córdoba

S3000FFU

Local Institution, Santa Fe

B-2650

Local Institution, Edegem

60430-230

Local Institution, Fortaleza

90050-170

Local Institution, Porto Alegre

90610-000

Local Institution, Porto Alegre, Rs

01508-010

Local Institution, São Paulo

T6G 1Z2

Local Institution, Edmonton

H1T 2W4

Local Institution, Montreal

H3T 1E2

Local Institution, Montreal

S7N 4H4

Local Institution, Saskatoon

Unknown

Local Institution, Santiago

Local Institution, Dublin

Local Institution, Galway

Local Institution, Cork

775 20

Local Institution, Olomouc

128 08

Local Institution, Prague

07740

Local Institution, Jena

00144

Local Institution, Rome

5623 EJ

Local Institution, Eindhoven

0310

Local Institution, Montebello

80-219

Local Institution, Gdansk

93-509

Local Institution, Lodz

20-090

Local Institution, Lublin

61-866

Local Institution, Poznan

51-124

Local Institution, Wroclaw

1099-023

Local Institution, Lisbon

0181

Local Institution, Groenkloof

0041

Local Institution, Pretoria

08036

Local Institution, Barcelona

CH-4031

Local Institution, Basel

BS2 8ED

Local Institution, Bristol

BH15 2JB

Local Institution, Poole

CM1 7ET

Local Institution, Chelmsford

SW3 6JJ

Local Institution, London

CH63 3JY

Local Institution, Metropolitan Borough of Wirral

GU2 7XX

Local Institution, Guildford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medarex

INDUSTRY

lead

Bristol-Myers Squibb

INDUSTRY