Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma
- Conditions
- GlioblastomaSmall Cell GlioblastomaGiant Cell GlioblastomaGliosarcomaGlioblastoma With Oligodendroglial Component
- Interventions
- Registration Number
- NCT01480479
- Lead Sponsor
- Celldex Therapeutics
- Brief Summary
This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer.
All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin.
Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.
- Detailed Description
The purpose of this research study is to find out whether adding an experimental vaccine called rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug temozolomide can help improve the life expectancy of patients with newly diagnosed, resected EGFRvIII positive glioblastoma.
The duration of participation in this study may be up to 5 years. After you are screened and enrolled in the study, you will be administered temozolomide and either rindopepimut/GM-CSF or KLH until either disease progression or intolerance to the medications. If your tumor progresses while on this study, your doctor may treat you with other therapies that are not part of the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 745
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rindopepimut/GM-CSF plus Temozolomide Rindopepimut (CDX-110) with GM-CSF - Rindopepimut/GM-CSF plus Temozolomide Temozolomide - KLH plus Temozolomide Temozolomide - KLH plus Temozolomide KLH -
- Primary Outcome Measures
Name Time Method Overall Survival During treatment and every three months from end of treatment through end of study or approximately up to 5 years. The primary efficacy endpoint of Overall Survival is defined as the number of months from randomization to the date of death (whatever the cause), and will be censored for patients who remain alive at completion of the study for patients with a gross total resection (\~n=374). The overall survival of patients will be monitored and compared between the two study arms until the end of the study.
- Secondary Outcome Measures
Name Time Method Progression-free survival Every 12 weeks from Day 1 through progression or initiation of other anti-cancer therapy Compare progression-free survival between the two treatment arms
Safety and Tolerability Until day 28 of follow up Safety and tolerability will be measured by comparing the two arms in regards to vital sign measurement, physical and neurological examination, adverse events reporting, ECOG performance status, and EORTC core Quality of Life Questionnaire
Trial Locations
- Locations (223)
Winship Cancer Institute, Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Launceston General Hospital
🇦🇺Launceston, Tasmania, Australia
Medical University Innsbruck, Dept of Neurology, Anichstrabe 35
🇦🇹Innsbruck, Austria
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Antwerp, Belgium
ZNA Middelheim
🇧🇪Antwerpen, Belgium
Centro de Pesquisas Clinicas da Fundação Dr Amaral Carvalho
🇧🇷Jaú, São Paulo, Brazil
British Columbia Cancer Agency, Vancouver Clinic
🇨🇦Vancouver, British Columbia, Canada
BC Cancer Agency - Vancouver Island Centre
🇨🇦Victoria, British Columbia, Canada
Klinik und Poliklinik fur Neurologie der Universitat Regensburg
🇩🇪Regensburg, Bavaria, Germany
Országos Onkológiai Intézet Sugárterápiás Osztály
🇭🇺Budapest, Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet
🇭🇺Debrecen, Hungary
Vas Megyei Markusovszky Lajos Általános Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktatókórház Nonprofit Zrt
🇭🇺Szombathely, Hungary
Amrita Institute of Medical Sciences and Research Centre, Kochi
🇮🇳Kochi, Kerala, India
Indraprastha Apollo Hospital, New Delhi
🇮🇳Jasola Viha, New Delhi, India
SHEBA Medical Center
🇮🇱Tel Hashomer, Israel
Oncology Institute of Southern Switzerland (IOSI)
🇨🇭Bellinzona, Switzerland
Hospital Almanzor Aguinaga Asenjo
🇵🇪Chiclayo, Peru
Instituto Oncologico Miraflores
🇵🇪Lima, Peru
Inselspital, Universitatsspital Bern, Universitatsklinik fur Medizinische Onkologie, Freiburgstrasse
🇨🇭Bern, Switzerland
Hopitaux Universitaires de Geneve-HUG-Centre d'Oncologie
🇨🇭Geneva, Switzerland
King Chulalongkorn Memorial Hospital
🇹🇭Patumwan, Bankok, Thailand
Brain Tumor Center, University Hospital Zurich
🇨🇭Zurich, Switzerland
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Dana-Farber Cancer Institute and Mass General Hospital
🇺🇸Boston, Massachusetts, United States
University Hospitals, Case Medical Center (Cleveland)
🇺🇸Cleveland, Ohio, United States
ICO Badalona-Hospital Germans Trias i Pujol
🇪🇸Barcelonia, Spain
Swedish Neuroscience Institute
🇺🇸Seattle, Washington, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Kaiser Permanente, Redwood City Medical Center
🇺🇸Redwood City, California, United States
Atlanta Cancer Care
🇺🇸Atlanta, Georgia, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Southeast Nebraska Cancer Center
🇺🇸Lincoln, Nebraska, United States
Northwestern University Robert H. Lurie Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Stanford Cancer Institute, Stanford University
🇺🇸Stanford, California, United States
Mount Sinai Medical Center, Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Covenant Clinic / Iowa Spine and Brain Institute
🇺🇸Waterloo, Iowa, United States
LSU Health Sciences Center, Feist-Weiller Cancer Center
🇺🇸Shreveport, Louisiana, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Ottawa Hospital, Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
The Long Island Brain Tumor Center at Neurology Surgery, P.C.
🇺🇸Great Neck, New York, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Hospital A C Camargo
🇧🇷São Paulo, Brazil
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Virginia Healthcare System
🇺🇸Charlottesville, Virginia, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
West Penn. Allegheny Health System
🇺🇸Pittsburgh, Pennsylvania, United States
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Epworth Healthcare
🇦🇺Richmond, Victoria, Australia
University of Tennessee Medical Center - Knoxville
🇺🇸Knoxville, Tennessee, United States
John Theurer Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Ellis Fischel Cancer Center
🇺🇸Columbia, Missouri, United States
Hospital Albert Einstein
🇧🇷Sao Paulo, Brazil
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Brain and Spine Surgeons of New York
🇺🇸White Plains, New York, United States
Liverpool Hospital
🇦🇺Liverpool, Australia
Fundação Faculdade Regional de Medicina de de São José do Rio Preto - Hospital de Base
🇧🇷São José do Rio Preto, São Paulo, Brazil
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Calvary North Adelaide Hospital
🇦🇺North Adelaide, South Australia, Australia
Lehigh Valley Physician Group-Hematology-Oncology Associates
🇺🇸Allentown, Pennsylvania, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Medizinische Universität Wien, Innere Medizin I, Onkologie
🇦🇹Vienna, Austria
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
CHUS Hôpital Fleurimont
🇨🇦Shenbrooke, Quebec, Canada
Service de Neurologie-GH
🇫🇷Paris, France
Instituto Nacional do Cancer (INCA)
🇧🇷Rio de Janeiro, Brazil
Real e Benemerita Associação Portuguesa de Beneficiência/ Hospital São José
🇧🇷São Paulo, Brazil
Hospital Na Homolce
🇨🇿Prague, Czechia
CHUQ L'Hotel Dieu de Qujebec
🇨🇦Quebec, Canada
Institut Gustave Roussy
🇫🇷Villejuif, France
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Foothills Hospital Medical Centre
🇨🇦Calgary, Alberta, Canada
University Hospital Hamburg Kopf und Neurozentrum
🇩🇪Hamburg, Germany
Ghent University Hospital
🇧🇪Ghent, Belgium
NNA
🇬🇷Athens, Attiki, Greece
Strahlenklinik Universitatsklinikum Erlangen
🇩🇪Erlangen, Germany
Instituto do Câncer do Estado de São Paulo - ICESP
🇧🇷São Paulo, Brazil
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Institut de Cancerologie de l'ouest-Center Rene Gauducheau
🇫🇷St Herblain, France
City Cancer Centre, Vijayawada
🇮🇳Vijayawada, Andhra Pradesh, India
Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
Hospital Clinic
🇪🇸Barcelona, Spain
Fundacion Santa Fe
🇨🇴Bogota, Bogota D.C, Colombia
Universita e AO Citta delia Scienza, Universita Di Torino
🇮🇹Torino, Italy
Institut de Cancerologie de L'Quest-Center Rane Gauducheau
🇫🇷Nantes, France
Centre Eugene Marquis
🇫🇷Rennes, France
Universitaetsklinikum Heidelberg, Neurologische Klinik, IM Neuenheimer Feld 672
🇩🇪Heidelberg, Germany
"HYGEIA" Hospital
🇬🇷Marousi, District Of Attica, Greece
Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Clinica Anglo Americana
🇵🇪Lima, Peru
CHUV, Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, VD, Switzerland
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
🇮🇳Andheri-West, Mumbai, India
Kantonsspital Aarau Medizinische Onkologie Tellstrasse
🇨🇭Aarau, AG, Switzerland
Chi Mei Medical Center
🇨🇳Tainan City - Yongkang District, Taiwan
Centre Leon Berard de Lyon
🇫🇷Lyon, France
Waikato Hospital, Regional Cancer Centre
🇳🇿Hamilton, Waikato District, New Zealand
Dr. Senchkenbergisches Institut fur Neuroonkologie
🇩🇪Frankfurt, Germany
Clinica Ricardo Palma
🇵🇪Lima, Peru
Soroka University M.C.
🇮🇱Beer-Sheva, Israel
Oncosalud
🇵🇪Lima, Peru
Dra. Sonia Del Barco Berron, ICO Girona Avda,
🇪🇸Franca, Girona, Spain
Institut Catala d Oncologia
🇪🇸LaHospitalet De Lubregat, Catalonia, Spain
Palmerston North Hospital
🇳🇿Roslyn, Palmerston North, New Zealand
LMU Munich
🇩🇪Munich, Germany
Guy's and St Thomas' NHS, Westminister Bridge Road
🇬🇧London, United Kingdom
Waikato Hospital, Regional Cancer Center
🇳🇿Hamilton, Waikato Distric, New Zealand
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Christchurch Hospital
🇳🇿Christchurch Central, Christchurch, New Zealand
Siriraj Hospital
🇹🇭Bangkoknoi, Bangkok, Thailand
Hospital Mae de Deus-Centro de Pesquisa em Oncologia Clinica
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Dr. Rai Memorial Medical Centre, Chennai
🇮🇳Chennai, Tamil Nadu, India
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
National Cheng Kung University Hospital
🇨🇳Tainan City, Bei District, Taiwan
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute
🇺🇸Minneapolis, Minnesota, United States
The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati Cancer Institute
🇺🇸Cincinnati, Ohio, United States
Providence Portland Medical Center, Oncology & Hematology Care
🇺🇸Portland, Oregon, United States
Pacific Neurosurgical
🇺🇸Portland, Oregon, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Utah Department of Neurosurgery
🇺🇸Salt Lake City, Utah, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
London Regional Cancer Program, London Health Sciences Centre
🇨🇦London, Ontario, Canada
Montreal Neurological Institute and Hospital
🇨🇦Montreal, Quebec, Canada
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Center for Cancer and Blood Disorders, PC
🇺🇸Bethesda, Maryland, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of South Alabama Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
City of Hope Cancer Center
🇺🇸Duarte, California, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
University of Arizona Health Network
🇺🇸Tucson, Arizona, United States
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Georgia Regents University
🇺🇸Augusta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
North Shore University Health System
🇺🇸Evanston, Illinois, United States
Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
St. Mary's of Michigan Medical Center/Field Neurosciences Institute
🇺🇸Saginaw, Michigan, United States
New Jersey Neuroscience Institute, JFK Medical Center
🇺🇸Edison, New Jersey, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Dent Neurosciences Research Institute
🇺🇸Amherst, New York, United States
Columbia University Medical Center - The Neurologic Institute of New York
🇺🇸New York, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
The Methodist Neurological Institute
🇺🇸Houston, Texas, United States
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Mater Adult Hospital, Mater Misericordiae Health Services Brisbane Limited
🇦🇺South Brisbane, Queensland, Australia
Szegedi Tudományegyetem Onkoterápiás Klinika
🇭🇺Szeged, Hungary
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
University of Manitoba-Cancer Care Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Institut de Cancerologie de I'Quest-Paul Papin
🇫🇷Angers, France
Hospital Ceske Budejovice
🇨🇿Ceske Budejovice, Czechia
Masaryk´s Hospital Usti nad Labem
🇨🇿Usti nad Labem, Czechia
Umiversity Hospital (Fakultni Nemocnice)
🇨🇿Prague, Czechia
Multiscan s.r.o.
🇨🇿Praha 5, Czechia
Institute Bergonie
🇫🇷Bordeaux, France
ICM Val d'Aurel Montpellier
🇫🇷Montpellier, France
University Medical Centre
🇩🇪Kiel, Germany
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Sugárterápiás Osztály
🇭🇺Miskolc, Hungary
Pécsi Tudományegyetem Általános Orvostudományi Kar
🇭🇺Pécs, Hungary
HCG - Bangalore Institute of Oncology, Bangalore
🇮🇳Bengaluru, Karnataka, India
Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram
🇮🇳Thiruvananthapuram, Kerala, India
Marathwada Regional Cancer Centre and Research Institute - Government
🇮🇳Aurangabad, Maharashtra, India
Tata Memorial Hospital , Mumbai
🇮🇳Parel, Mumbai, India
Sahyadri Hospitals Limited
🇮🇳Erandauame, Pune, India
HCG Shanti Mukand Hospital - Curie Cancer Centre, Delhi
🇮🇳Delhi, India
Rambam Health Care Campus
🇮🇱Haifa, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Fondazione IRCCS Instituto Neurologico Carlo Besta
🇮🇹Milano, Italy
UO Oncologie Medica Dipartimento Oncologico
🇮🇹Bologna, Italy
Tel-Aviv Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
Grupo Médico Camino S.C.
🇲🇽Mexico, D.F, Mexico
Sacred Heart Catholic University
🇮🇹Rome, Italy
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
🇲🇽Guadalajara, Jalisco, Mexico
Servicios Medicos de Investigacion Clinica Sc
🇲🇽Durango, Mexico
Ensayos Clínicos y Medicina de Alta Especialidad, S.C.
🇲🇽Culiacán, Sinaloa, Mexico
Hospital Central "Ignacio Morones Prieto"
🇲🇽San Luis Potosí, Mexico
Medisch Centrum Haaglanden
🇳🇱The Hague, Zuid Holland, Netherlands
VUMC
🇳🇱Amsterdam, Netherlands
Radboud University Nijmegen Medical Center
🇳🇱Nijmegen, Netherlands
Chang Gung Memorial Hospital Linkou Branch
🇨🇳Taichung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Tri-Service General Hospital
🇨🇳Taipei city - Neihu District, Taiwan
Songkhlanagarind Hospital
🇹🇭Hat Yai, Songkla, Thailand
Maharaj Nakorn Chiang Mai Hospital
🇹🇭Amphoe Muang, Chiang Mai, Thailand
The Bristol Haematology and Oncology Centre
🇬🇧Bristol, United Kingdom
Beatson West of Scotland Cancer Centrel
🇬🇧Glasgow, United Kingdom
Royal Marsden NHS Foundation Trust
🇬🇧Sutton, Surrey, United Kingdom
Edinburgh Cancer Centre Western General Hospital
🇬🇧Edinburgh, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
University of California, Davis
🇺🇸Sacramento, California, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina - Department of Neuroscience
🇺🇸Charleston, South Carolina, United States
Yale University Medical Center
🇺🇸New Haven, Connecticut, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Texas Oncology Midtwon
🇺🇸Austin, Texas, United States
MD Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Kaiser Permanente Hawaii Moanalua Medical Center
🇺🇸Honolulu, Hawaii, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Wisconsin Paul P Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
The Crown Princess Mary Cancer Centre, Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Montefiore Medical Center
🇺🇸Bronx, New York, United States