Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma

PHASE3CompletedINTERVENTIONAL
Enrollment

745

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

November 30, 2016

Study Completion Date

November 30, 2016

Conditions
GlioblastomaSmall Cell GlioblastomaGiant Cell GlioblastomaGliosarcomaGlioblastoma With Oligodendroglial Component
Interventions
DRUG

Rindopepimut (CDX-110) with GM-CSF

"Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance.~Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF."

DRUG

Temozolomide

150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, or until intolerance or progression.

DRUG

KLH

Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8mL containing approximately 100mcg of KLH.

Trial Locations (223)

704

National Cheng Kung University Hospital, Tainan City

710

Chi Mei Medical Center, Tainan City - Yongkang District

1011

CHUV, Centre Hospitalier Universitaire Vaudois, Lausanne

1090

Medizinische Universität Wien, Innere Medizin I, Onkologie, Vienna

1122

Országos Onkológiai Intézet Sugárterápiás Osztály, Budapest

1211

Hopitaux Universitaires de Geneve-HUG-Centre d'Oncologie, Geneva

2031

Prince of Wales Hospital, Randwick

2107

Liverpool Hospital, Liverpool

2145

The Crown Princess Mary Cancer Centre, Westmead Hospital, Westmead

2605

Royal North Shore Hospital, St Leonards

2650

Universitair Ziekenhuis Antwerpen, Edegem

3010

Inselspital, Universitatsspital Bern, Universitatsklinik fur Medizinische Onkologie, Freiburgstrasse, Bern

3084

Austin Health, Heidelberg

3121

Epworth Healthcare, Richmond

3199

Monash Medical Centre, Clayton

3240

Waikato Hospital, Regional Cancer Centre, Hamilton

Waikato Hospital, Regional Cancer Center, Hamilton

3526

Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Sugárterápiás Osztály, Miskolc

4029

Royal Brisbane and Women's Hospital, Herston

4032

Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet, Debrecen

4101

Mater Adult Hospital, Mater Misericordiae Health Services Brisbane Limited, South Brisbane

4414

Palmerston North Hospital, Roslyn

5000

Royal Adelaide Hospital, Adelaide

5001

Kantonsspital Aarau Medizinische Onkologie Tellstrasse, Aarau

5006

Calvary North Adelaide Hospital, North Adelaide

6020

Medical University Innsbruck, Dept of Neurology, Anichstrabe 35, Innsbruck

6500

Oncology Institute of Southern Switzerland (IOSI), Bellinzona

6720

Szegedi Tudományegyetem Onkoterápiás Klinika, Szeged

7000

Royal Hobart Hospital, Hobart

7250

Launceston General Hospital, Launceston

7624

Pécsi Tudományegyetem Általános Orvostudományi Kar, Pécs

8011

Christchurch Hospital, Christchurch Central

8036

Hospital Clinic, Barcelona

8091

Brain Tumor Center, University Hospital Zurich, Zurich

9000

Ghent University Hospital, Ghent

9700

Vas Megyei Markusovszky Lajos Általános Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktatókórház Nonprofit Zrt, Szombathely

10032

Columbia University Medical Center - The Neurologic Institute of New York, New York

10065

Weill Cornell Medical College, New York

10126

Universita e AO Citta delia Scienza, Universita Di Torino, Torino

10330

King Chulalongkorn Memorial Hospital, Patumwan

10467

Montefiore Medical Center, The Bronx

10604

Brain and Spine Surgeons of New York, White Plains

10700

Siriraj Hospital, Bangkoknoi

11021

The Long Island Brain Tumor Center at Neurology Surgery, P.C., Great Neck

11215

New York Methodist Hospital, Brooklyn

11521

NNA, Athens

13210

SUNY Upstate Medical University, Syracuse

14226

Dent Neurosciences Research Institute, Amherst

14642

University of Rochester Medical Center, Rochester

15212

West Penn. Allegheny Health System, Pittsburgh

15232

University of Pittsburgh Cancer Institute, Pittsburgh

17007

Dra. Sonia Del Barco Berron, ICO Girona Avda,, Franca

18103

Lehigh Valley Physician Group-Hematology-Oncology Associates, Allentown

19104

University of Pennsylvania, Philadelphia

19140

Temple University Hospital, Philadelphia

19713

Christiana Care Health Services, Newark

20133

Fondazione IRCCS Instituto Neurologico Carlo Besta, Milan

20246

University Hospital Hamburg Kopf und Neurozentrum, Hamburg

20817

Center for Cancer and Blood Disorders, PC, Bethesda

21231

Johns Hopkins University School of Medicine, Baltimore

21401

Anne Arundel Medical Center, Annapolis

22908

University of Virginia Healthcare System, Charlottesville

24105

University Medical Centre, Kiel

27157

Wake Forest Baptist Health, Winston-Salem

27710

The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center, Durham

28041

Hospital 12 de Octubre, Madrid

29425

Medical University of South Carolina - Department of Neuroscience, Charleston

30005

Atlanta Cancer Care, Atlanta

30322

Winship Cancer Institute, Emory University School of Medicine, Atlanta

30912

Georgia Regents University, Augusta

32611

University of Florida, Gainesville

32806

MD Anderson Cancer Center Orlando, Orlando

33076

Institute Bergonie, Bordeaux

33140

Mount Sinai Medical Center, Comprehensive Cancer Center, Miami Beach

33606

Tampa General Hospital, Tampa

34000

"Hospital Civil de Guadalajara Fray Antonio Alcalde", Guadalajara

Servicios Medicos de Investigacion Clinica Sc, Durango

35042

Centre Eugene Marquis, Rennes

35294

University of Alabama at Birmingham, Birmingham

36604

University of South Alabama Mitchell Cancer Institute, Mobile

37203

Sarah Cannon Research Institute, Nashville

37232

Vanderbilt-Ingram Cancer Center, Nashville

37920

University of Tennessee Medical Center - Knoxville, Knoxville

40139

UO Oncologie Medica Dipartimento Oncologico, Bologna

40202

Norton Cancer Institute, Louisville

40705

Chang Gung Memorial Hospital Linkou Branch, Taichung

Taichung Veterans General Hospital, Taichung

43210

Ohio State University, Columbus

44106

University Hospitals, Case Medical Center (Cleveland), Cleveland

44195

Cleveland Clinic Foundation, Cleveland

44805

Institut de Cancerologie de L'Quest-Center Rane Gauducheau, Nantes

Institut de Cancerologie de l'ouest-Center Rene Gauducheau, Saint-Herblain

45267

University of Cincinnati Cancer Institute, Cincinnati

48109

University of Michigan Health System, Ann Arbor

48149

Universitaetsklinikum Muenster, Münster

48604

St. Mary's of Michigan Medical Center/Field Neurosciences Institute, Saginaw

48912

Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center, Lansing

49933

Institut de Cancerologie de I'Quest-Paul Papin, Angers

50200

Maharaj Nakorn Chiang Mai Hospital, Amphoe Muang

50702

Covenant Clinic / Iowa Spine and Brain Institute, Waterloo

52126

SHEBA Medical Center, Tel Litwinsky

53226

Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin Paul P Carbone Comprehensive Cancer Center, Madison

55407

Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute, Minneapolis

60153

Loyola University Medical Center, Maywood

60201

North Shore University Health System, Evanston

60611

Northwestern University Robert H. Lurie Comprehensive Cancer Center, Chicago

60612

Rush University Medical Center, Chicago

60637

University of Chicago, Chicago

63110

Washington University in St. Louis, St Louis

64239

Tel-Aviv Sourasky Medical Center, Tel Aviv

65203

Ellis Fischel Cancer Center, Columbia

68510

Southeast Nebraska Cancer Center, Lincoln

69120

Universitaetsklinikum Heidelberg, Neurologische Klinik, IM Neuenheimer Feld 672, Heidelberg

69373

Centre Leon Berard de Lyon, Lyon

70809

Mary Bird Perkins Cancer Center, Baton Rouge

71103

LSU Health Sciences Center, Feist-Weiller Cancer Center, Shreveport

72205

University of Arkansas for Medical Sciences, Little Rock

75013

Service de Neurologie-GH, Paris

75246

Baylor Research Institute, Dallas

77030

The Methodist Neurological Institute, Houston

78240

"Hospital Central Ignacio Morones Prieto", San Luis Potosí City

78705

Texas Oncology Midtwon, Austin

80020

Ensayos Clínicos y Medicina de Alta Especialidad, S.C., Culiacán

83301

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

84101

Soroka University M.C., Beersheba

84112

University of Utah Department of Neurosurgery, Salt Lake City

85013

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center, Phoenix

85724

University of Arizona Health Network, Tucson

90033

USC Norris Comprehensive Cancer Center, Los Angeles

90110

Songkhlanagarind Hospital, Hat Yai

91010

City of Hope Cancer Center, Duarte

91120

Hadassah Medical Center, Jerusalem

92093

UC San Diego Moores Cancer Center, La Jolla

92868

Chao Family Comprehensive Cancer Center, Orange

93053

Klinik und Poliklinik fur Neurologie der Universitat Regensburg, Regensburg

94063

Kaiser Permanente, Redwood City Medical Center, Redwood City

94143

University of California, San Francisco, San Francisco

94305

Stanford Cancer Institute, Stanford University, Stanford

94805

Institut Gustave Roussy, Villejuif

95817

University of California, Davis, Sacramento

96819

Kaiser Permanente Hawaii Moanalua Medical Center, Honolulu

97213

Providence Portland Medical Center, Oncology & Hematology Care, Portland

97227

Pacific Neurosurgical, Portland

98122

Swedish Neuroscience Institute, Seattle

98195

University of Washington Medical Center, Seattle

110076

Indraprastha Apollo Hospital, New Delhi, Jasola Viha

110092

HCG Shanti Mukand Hospital - Curie Cancer Centre, Delhi, Delhi

342298

ICM Val d'Aurel Montpellier, Montpellier

400012

Tata Memorial Hospital , Mumbai, Pārel

411004

Sahyadri Hospitals Limited, Erandauame

431001

Marathwada Regional Cancer Centre and Research Institute - Government, Aurangabad

520002

City Cancer Centre, Vijayawada, Vijayawada

560027

HCG - Bangalore Institute of Oncology, Bangalore, Bengaluru

600018

Dr. Rai Memorial Medical Centre, Chennai, Chennai

3109601

Rambam Health Care Campus, Haifa

06102

Hartford Hospital, Hartford

06520

Yale University Medical Center, New Haven

40536-0093

University of Kentucky, Lexington

02115

Dana-Farber Cancer Institute and Mass General Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

01655

University of Massachusetts Memorial Medical Center, Worcester

03756

Dartmouth Hitchcock Medical Center, Lebanon

08818

New Jersey Neuroscience Institute, JFK Medical Center, Edison

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

07740

Monmouth Medical Center, Long Branch

11030-3186

North Shore University Hospital, Manhasset

05405

Fletcher Allen Health Care, Burlington

06008

Sir Charles Gairdner Hospital, Nedlands

B-2020

ZNA Middelheim, Antwerp

90840-440

Hospital Mae de Deus-Centro de Pesquisa em Oncologia Clinica, Porto Alegre

17210-120

Centro de Pesquisas Clinicas da Fundação Dr Amaral Carvalho, Jaú

15090-000

Fundação Faculdade Regional de Medicina de de São José do Rio Preto - Hospital de Base, São José do Rio Preto

20231-050

Instituto Nacional do Cancer (INCA), Rio de Janeiro

01246-000

Instituto do Câncer do Estado de São Paulo - ICESP, São Paulo

01321-001

Real e Benemerita Associação Portuguesa de Beneficiência/ Hospital São José, São Paulo

01509-900

Hospital A C Camargo, São Paulo

05652-900

Hospital Albert Einstein, São Paulo

T3J 5N6

Foothills Hospital Medical Centre, Calgary

V5Z 4E6

British Columbia Cancer Agency, Vancouver Clinic, Vancouver

V8X 4V6

BC Cancer Agency - Vancouver Island Centre, Victoria

R3E0V9

University of Manitoba-Cancer Care Manitoba, Winnipeg

B3H 1V7

QEII Health Sciences Centre, Halifax

L8V 5C2

Juravinski Cancer Centre, Hamilton

N6A 4L6

London Regional Cancer Program, London Health Sciences Centre, London

K1H 8L6

Ottawa Hospital, Regional Cancer Centre, Ottawa

M4N3M5

Sunnybrook Health Sciences Centre, Toronto

H2L 4M1

Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame, Montreal

H3A 2B4

Montreal Neurological Institute and Hospital, Montreal

G1R 2J6

CHUQ L'Hotel Dieu de Qujebec, Québec

J1H5N4

CHUS Hôpital Fleurimont, Shenbrooke

000

Fundacion Santa Fe, Bogotá

370 01

Hospital Ceske Budejovice, České Budějovice

150 06

Umiversity Hospital (Fakultni Nemocnice), Prague

150 30

Hospital Na Homolce, Prague

155-00

Multiscan s.r.o., Prague

401-13

Masaryk´s Hospital Usti nad Labem, Ústí nad Labem

D-91054

Strahlenklinik Universitatsklinikum Erlangen, Erlangen

D-60528

Dr. Senchkenbergisches Institut fur Neuroonkologie, Frankfurt

D-81377

LMU Munich, Munich

151 23

"HYGEIA Hospital", Marousi

682 026

Amrita Institute of Medical Sciences and Research Centre, Kochi, Kochi

695 011

Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram, Thiruvananthapuram

400 053

Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Andheri-West

00168

Sacred Heart Catholic University, Rome

03310

Grupo Médico Camino S.C., México

2512 VA

Medisch Centrum Haaglanden, The Hague

1081HV

VUMC, Amsterdam

6525 GA

Radboud University Nijmegen Medical Center, Nijmegen

Unknown

Hospital Almanzor Aguinaga Asenjo, Chiclayo

Lima 18

Instituto Oncologico Miraflores, Lima

Lima 27

Clinica Anglo Americana, Lima

Clinica Ricardo Palma, Lima

Lima 41

Oncosalud, Lima

08908

Institut Catala d Oncologia, LaHospitalet de Lubregat

08916

ICO Badalona-Hospital Germans Trias i Pujol, Barcelonia

00114

Tri-Service General Hospital, Taipei City - Neihu District

SM2 5PT

Royal Marsden NHS Foundation Trust, Sutton

BS2 8ED

The Bristol Haematology and Oncology Centre, Bristol

EH4 2XU

Edinburgh Cancer Centre Western General Hospital, Edinburgh

G12 0NY

Beatson West of Scotland Cancer Centrel, Glasgow

SE17EH

Guy's and St Thomas' NHS, Westminister Bridge Road, London

NG5 1PB

Nottingham City Hospital, Nottingham

Sponsors
All Listed Sponsors
lead

Celldex Therapeutics

INDUSTRY

NCT01480479 - Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma | Biotech Hunter | Biotech Hunter