MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma

PHASE3CompletedINTERVENTIONAL
Enrollment

1,783

Participants

Timeline

Start Date

September 30, 2004

Primary Completion Date

August 31, 2009

Study Completion Date

October 31, 2009

Conditions
MelanomaMetastases
Interventions
DRUG

MDX-010 (anti-CTLA4) monoclonal antibody

3mg/kg (intravenous \[iv\] infusion over 90 minutes), every 3 weeks for 4 doses

BIOLOGICAL

MDX-1379 (gp100) Melanoma Peptide Vaccine

2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.

Trial Locations (209)

1000

Institut Jules Bordet, Brussels

1070

Erasme Hospital, Free Universtiy of Brussels, Brussels

Erasme Hospital, Brussels

1900

Instituto Medico Platense, La Plata

2199

Sandton Onocology Medical Research, Sandton

3000

Universitair Ziekenhuis Gasthuisberg, Leuven

5530

Cliniques Universitaires UCL de Mont-Godinne, Yvoir

7500

GVI Oncology, Panorama

8091

Dermatologische Klinik Universitatsspital Zurich, Zurich

9000

U.Z. Gent, Ghent

10021

Memorial Sloan Kettering Cancer Center, New York

10032

Columbia University Medical Center, Irving Center for Clinical Research, New York

10117

Charite Universitaets medizin Berlin, Berlin

12200

Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin, Berlin

13009

Hopital Sainte-Marguerite, Marseille

13057

Hematology-Oncology Associates of CNY, East Syracuse

15213

Hillman Cancer Research Pavilion, Pittsburgh

15232

Hillman Cancer Center, Pittsburgh

University of Pittsburgh Cancer Institute, Pittsburgh

17033

Penn State Milton S. Hershey Medical Center, Hershey

19107

Thomas Jefferson University Hosptital, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

21093

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Lutherville

21231

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

21237

Franklin Square Hospital Center, Baltimore

29307

Cancer Centers of the Carolinas, Spartanburg

29615

Cancer Centers of the Carolinas, Greenville

29640

Cancer Centers of the Carolinas, Easley

29672

Cancer Centers of the Carolinas, Seneca

30322

Emory University Hospital-Winship Cancer Institute, Atlanta

32209

Shands Jacksonville, Jacksonville

University of Florida/Jacksonville Faculty Clinic, Jacksonville

32806

M.D. Anderson Cancer Center Orlando, Orlando

33021

Memorial Regional Cancer Center, Hollywood

33136

Jackson Memorial Hospital & Clinics, Miami

University of Miami Hospital & Clinics, Miami

33140

Mount Sinai Comprehensive Cancer Center, Miami Beach

Mount Sinai Medical Center, Miami Beach

33180

Mount Sinai Comprehensive Cancer Center at Aventura, Aventura

33401

Palm Beach Cancer Institute, West Palm Beach

33410

Palm Beach Cancer Institute, Palm Beach Gardens

33414

Palm Beach Cancer Institute, Wellington

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

37232

Vanderbilt University Medical Center, Nashville

38017

Family Cancer Center, Collierville

38119

Family Cancer Center, Memphis

38120

The West Clinic, Memphis

38133

Family Cancer Center, Bartlett

38654

Family Cancer Center, Olive Branch

40202

James Graham Brown Cancer Center, Louisville

Norton Hospital, Louisville

University of Louisville Hospital, Louisville

40225

Universitaetsklinikum Dusseldorf, Düsseldorf

40503

Central Baptist Hospital, Lexington

44195

The Cleveland Clinic Foundation, Cleveland

45122

Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie, Hufelandstr. 55

Universitaetsklinikum Essen, Essen

45219

The Christ Hospital Cancer Center, Cincinnati

46060

Indiana Oncology Hematology Consutants of Noblesville, Noblesville

46202

Indiana Oncology Hematology Consultants North, Indianapolis

46237

American Health Network of IN, LLC, Indianapolis

Indiana Oncology Hematology South, Indianapolis

46526

Center for Cancer Care at Goshen Health System, Goshen

48126

Henry Ford Medical Center, Dearborn

48202

Henry Ford Hospital, Detroit

48322

Henry Ford Medical Center- West Bloomfield, West Bloomfield

55422

Hubert H Humphrey Cancer Center, Robbinsdale

55432

Humphrey Cancer Center, Fridley

55433

Humphrey Cancer Center, Coon Rapids

60153

Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr., Maywood

62401

Cancer Care Specialists of Central IL, Effingham

62526

Cancer Care Specialists of Central IL, Decatur

Decatur Memorial Hospital, Decatur

63110

Barnes Jewish Hospital, St Louis

Washington Unv. School of Med./ Siteman Cancer Center, St Louis

64507

St. Joseph Oncology, Inc, Saint Joseph

65203

Ellis Fischel Cancer Center, Columbia

68167

Klinikum Mannheim gGmbH, Mannheim

69115

Universitaetsklinikum Heidelberg, Heidelberg

72076

Universitaetsklinikum Tuebingen, Tübingen

75080

Center for Oncology Research and Treatment, Richardson

75230

Center for Oncology Research and Treatment, Dallas

76012

Arlington Cancer Center, Arlington

79410

Joe Arrington Cancer Research and Treatment Center, Lubbock

80010

Anschutz Cancer Pavilion, Aurora

80012

Rocky Mountain Cancer Centers, Aurora

80045

University of Colorado Health Sciences Center, Aurora

80120

Rocky Mountain Cancer Centers, Littleton

80124

Rocky Mountain Cancer Centers, Lone Tree

80218

Rocky Mountain Cancer Centers, Denver

80228

Rocky Mountain Cancer Centers, Lakewood

80262

University of Colorado Hospital, Denver

80304

Rocky Mountain Cancer Centers, Boulder

80501

Rocky Mountain Cancer Centers, Longmont

80909

Rocky Mountain Cancer Centers, Colorado Springs

81675

Klinikum Rechts der Isar / TU Muenchen, München

84112

Huntsman Cancer Institute, Salt Lake City

85724

Arizona Cancer Center, Tucson

University Medical Center, Tucson

86156

Klinikum Augsburg, Augsburg

87109

New Mexico Oncology Hematology Consultants, Ltd., Albuquerque

90025

Cancer Institute Medical Group, Inc, Los Angeles

The Angeles Clinic and Research Institute, Los Angeles

90033

USC/Norris Comprehensive Cancer Center, Los Angeles

90404

Cancer Institute Medical Group, Inc, Santa Monica

90813

Pacific Shores Medical Group, Long Beach

91010

City of Hope National Medical Center, Duarte

91052

Universitaetsklinikum Erlangen, Erlangen

91105

City of Hope Medical Group, Pasadena

92024

San Diego Cancer Center, Encinitas

92037

La Jolla Hematology and Oncology Medical Group, La Jolla

Scripps Cancer Center, La Jolla

92056

North County Oncology Medical Clinical, Inc., Oceanside

92081

San Diego Cancer Center, Vista

92093

Moores UCSD Cancer Center, La Jolla

92103

University of California, San Diego, San Diego

94109

St. Mary's Medical Center - Northern California Melanoma Center, San Francisco

97080

Universitaetsklinikum Wuerzburg, Würzburg

97213

Providence Portland Medical Center, Portland

The Oregon Clinical, Portland

06520

Yale University School of Medicine - Oncology Outpatient Clinic, New Haven

02115

Beth Isreal Dec Medical Center, Boston

Brigham and Womens Hospital, Boston

Dana Farber Cancer Institute, Boston

07601

Hackensack University Medical Center, Hackensack

The Cancer Center at Hackensack University Medical Center, Hackensack

07962

Hematology-Oncology Associates of Northern NJ, PA, Morristown

08901

Robert Wood Johnson University Hospital, New Brunswick

The Cancer Institute of New Jersey, New Brunswick

07901

Overlook Oncology Center, Summit

27599-7050

University of North Carolina at Chapel Hill, Chapel Hill

84112-5550

Huntsman Cancer Institute, Salt Lake City

05405

Fletcher Allen Health Care, Burlington

Unknown

Hospital Municipal de Oncoligia Maria Curie, Ciudad de Buenos Aires

ISIS Clinica Especializada, Santa Fe

Hospital Militar Central, Buenos Aires

Instituto Medico Especializado Alexander Fleming, Buenos Aires

Hospital Privado Centro Medico de Cordoba S.A., Córdoba

Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias, Goiânia

Pro Onco Centro Tratamento Oncologico, Londrina

Hospital Sao Lucas da PUCRS, Porto Alegre

Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos

Fundacoa Hospital Amaral Carvalho, Jaú

Santo Andre Diagnosticos aTratamentos, Santo André

Sociedade Beneficante de Sennores - Hospital Sino Libante, São Paulo

Instituto Nacional del Cancer, Independencia

Clinica Davila, Recoleta

Fundacion Arturo Lopez Perez, Santiago

Hospital Barros Luco, Santiago

Clinica Renaca, Reñaca

University of Mannheim, Mannheim

C1280AEB

Hospital Britanico de Buenos Aires, Ciudad de Buenos Aires

C1405BWU

Hospital Municipal de Oncologia Maria Curie, Ciudad de Buenos Aires

C1405DCS

Hospital General de Agudos Carlos G. Durand, Ciudad de Buenos Aires

C1417DTB

Instituto de Oncologia Angel H. Roffo, Ciudad de Buenos Aires

C1426BOS

Hospital Militar Central, Ciudad de Buenos Aires

C1426DRB

Instituto Alexander Fleming, Ciudad de Buenos Aires

X5016KEH

Hospital Privado de Cordoba S.A., Córdoba

S3000FFU

ISIS Clinica Especializada, Santa Fe

14784-400

Hospital de Cancer de Barretos - Fundacao Pio XII, Barretos - SP

34000-000

Biocor - Hosp. de Doencas Cardiovasculares Ltda., Belo Horizonte - MG

74605-070

Hospital Araujo Jorge, Goiania - GO

86050-190

Pro Onco Centro Tratemento Oncologico, Londrina - PR

90035-003

Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD, Porto Alegre

Fund. SOAD / HC de Porto Alegre, Porto Alegre - RS

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre - RS

09090-780

Santo Andre Diagnosticos e Tratamentos Ltda., Santo Andre-SP

05403-000

HC-FMUSP, Sao Paulo - SP

01308-050

Hospital Sirio Labanes, Sao Paulo-SP

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

R3E 0V9

CancerCare Manitoba, Winnipeg

A1B 3V6

Dr. H. Bliss Murphy Cancer Centre, St. John's

K7L 5P9

Cancer Centre of Southeastern Ontario at KGH, Kingston

N6A 4L6

London Regional Cancer Program, London

K1H 8L6

The Ottawa Hospital Regional Cancer Centre, Ottawa

M5G 2M9

Princess Margaret Hospital, Toronto

H3T 1E2

Sir Mortimer B. Davis - Jewish General Hospital, Montreal

59020 Cedex

Centre Oscar Lambret, Lille

69373 Cedex 08

Centre Leon Berard, Lyon

34295 Cedex 5

Hopital Saint-Eloi, Montpellier

44093 Cedex 1

Hotel Dieu, Nantes

06189

Centre Antoine Lacassagne, Nice

75010 10

Hopital Saint-Louis, Paris

35042 Cedex

Centre Eugene Marquis, Rennes

42055 Cedex 2

Centre-Hospitalier Universitaire de Saint-Etienne, Saint-Etienne

54511 Cedex

Centre Alexis Vautrin, Vandœuvre-lès-Nancy

94805 Cedex

Institut Gustave Roussy (IGR), Villejuif

07740

Klinikum der Friedrich-Schiller-Universitaet Jena, Jena

H-1122

National Institute of Oncology, Budapest

H-4012

University of Debrecen, Medical and Health Sciences Center, Debrecen

H-3529

Semmelweis Hospital, Miskolc

H-6720

University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center, Szeged

1066 CX

Antoni Van Leeuwenhoek Ziekenhuis, Amsterdam

1081 HV

Vrije Universiteit Medisch Centrum (VUMC), Amsterdam

6229 HX

Academisch Ziekenhuis Maastricht, Maastricht

0181

Mary Potter Oncology Centre, Groenkloof

Mary Potter Oncology Centre, Pretoria

CH-1011

Centre Hospitalier Universitaire Vaudois - CHUV, Lausanne

Centre Hospitalier Universitaire Vaudois - CHUV, Lausanne

GU2 7XX

St. Luke's Cancer Center, The Royal Surrey County Hospital, Guildford

CF14 2TL

Velindre Hospital, Cardiff

DD1 9SY

Ninewells Hospital, Dundee

M20 4BX

Christie Hospital, Manchester

NG5 1PB

Nottingham City Hospital, Nottingham

OX3 7LJ

Churchill Hospital, Oxford

BH15 2JB

Poole Hospital, Poole

S10 2SJ

Weston Park Hospital, Sheffield

SO16 6YD

Southampton General, Southampton

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY