Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma

PHASE3CompletedINTERVENTIONAL
Enrollment

437

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

February 28, 2013

Study Completion Date

September 30, 2014

Conditions
Melanoma
Interventions
BIOLOGICAL

Talimogene laherparepvec

Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection

BIOLOGICAL

GM-CSF

125 µg/m² subcutaneous injection

Trial Locations (83)

2193

Wits Donald Gordon Clinical Trial Site, Parktown

2196

Medical Oncology Centre of Rosebank, Johannesburg

3201

Hopelands Cancer Centre, Pietermaritzburg

6045

GVI Oncology, Port Elizabeth

7500

GVI Onocology Clinical Trials Unit, Cape Town

9301

Dr. Fourie & Bonnet, Bloemfontein

10032

Columbia Medical University, New York

Mount Sinai School of Medicine, New York

14263

Roswell Park Cancer Institute, Buffalo

18015

St Luke's Hospital & Health Network, Bethlehem

19107

Thomas Jefferson University, Philadelphia

24153

Oncology and Hematology Associates of Southwest Virginia, Inc., Salem

27157

Wake Forest University School of Medicine, Winston-Salem

27599

University of North Carolina At Chapel Hill School of Medicine, Chapel Hill

27710

Duke University Medical Center, Durham

29425

Medical University of South Carolina, Charleston

29605

Institute for Translational Oncology Research, Greenville

30322

Emory University, Atlanta

32207

Baptist Cancer Institute, Jacksonville

32806

MD Anderson Cancer Center Orlando, Orlando

33136

University of Miami, Miami

33140

Mount Sinai Medical Center CCOP, Miami Beach

33401

Palm Beach Cancer Institute, West Palm Beach

33612

H. Lee Moffitt Cancer Center, Tampa

33805

Lakeland Regional Cancer Center, Lakeland

37232

Vanderbilt Ingram Cancer Center, Nashville

40202

James Graham Brown Cancer Center, Louisville

44195

Cleveland Clinic Foundation, Taussig Cancer Center, Cleveland

44718

Gabrail Cancer Center, Canton

45267

Barrett Cancer Center, Cincinnati

46202

Indiana University, Indianapolis

46254

Investigative Clinical Research of Indiana, Indianapolis

52242

University of Iowa Hospitals & Clinics, Iowa City

53215

Aurora/St. Luke's Medical Center, Milwaukee

55422

Hubert H Humphrey Cancer Center, Robbinsdale

55905

Mayo Clinic, Rochester

60068

Cancer Care Center at Lutheran General Hospital, Park Ridge

60612

Rush University Medical Center, Chicago

63110

St. Louis University Hospital, St Louis

Washington University School of Medicine, St Louis

66205

University of Kansas Medical Center, Kansas City

66210

Kansas City Cancer Center, Kansas City

68114

Methodist Estabrook Cancer Center, Omaha

72205

University of Arkansas for Medical Sciences, Little Rock

75246

Mary Crowley Medical Research Center, Dallas

77030

University of Texas - MD Anderson, Houston

79701

Texas Cancer Center, Abilene, Abilene

Texas Oncology, Allison Cancer Center, Midland

80014

University of Colorado Cancer Center, Aurora

84107

Intermountain Medical Center, Murray

84112

Huntsman Cancer Institute, Salt Lake City

85724

University of Arizona Cancer Center, Tucson

87109

New Mexico Cancer Care Alliance, Albuquerque

90095

UCLA Medical Center, Los Angeles

90404

John Wayne Cancer Institute, Santa Monica

92093

University of California San Diego, Moores Cancer Center, La Jolla

94115

San Francisco Oncology Associates, San Francisco

94117

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

95472

Redwood Regional Medical Group Inc, North Bay Melanoma Program, Sebastopol

97213

Earle A Chiles Research Institute, Providence Cancer Center, Portland

02114

Massachusetts General Hospital Cancer Center, Boston

07962

Mountainside Hospital, Morristown

02905

Rhode Island Hospital, Providence

T6G 1Z2

Cross Cancer Institute, Edmonton

M5G2M9

Princess Margaret Hospital, Toronto

H3T 1E2

Jewish General Hospital, Montreal

0001

University of Pretoria, Pretoria

0075

Mary Potter Oncology Centre, Pretoria

0028

Wilgers Oncology Center, Hatfield

Unknown

GVI Oncology Centre, Cape Town

B15 2TT

University of Birmingham, Birmingham

CB2 0QQ

Addenbrookes Hospital, Cambridge

CM1 7ET

Broomfield Hospital, Chelmsford

LS9 7TF

St. James's University Hospital, Leeds

LE1 5WW

Leicester Royal Infirmary, Leicester

NW3 2QG

Royal Free Hospital, London

SW17 0RE

St. George's University of London, London

SW3 6JJ

Royal Marsden Hospital, London

CH63 4JY

Clatterbridge Centre for Oncology, Metropolitan Borough of Wirral

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

NG5 1PB

Nottingham City Hospital, Nottingham

OX3 7LJ

Churchill Hospital, Oxford

SO16 6YD

Southampton General Hospital, Southampton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

BioVex Limited

INDUSTRY

NCT00769704 - Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma | Biotech Hunter | Biotech Hunter