Clinical trial NCT01480479: Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma
Official title: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glioblastoma
Small Cell Glioblastoma
Giant Cell Glioblastoma
Gliosarcoma
Glioblastoma With Oligodendroglial Component
Keywords: EGFRvIII
Glioblastoma
Small cell
Giant cell
Gliosarcoma
oligodendroglial
Brain Cancer
Brain Tumor
radiotherapy
chemoradiation
Tumor
temozolomide
EGFR variant III
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-11-29
Enrollment: 745
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria-

Among other criteria, patients must meet the following conditions to be eligible for the study:

1. Adult patients, ≥ 18 years old
2. Newly diagnosed glioblastoma
3. Attempted surgical resection followed by conventional chemoradiation
4. Documented EGFRvIII positive tumor status by a Sponsor designated laboratory
5. No evidence of progressive disease from the post-operative period to the post-chemoradiation period
6. Candidate for, and agrees to receive, adjuvant (maintenance) temozolomide therapy
7. Systemic corticosteroid therapy at ≤2 mg of dexamethasone or equivalent per day for at least 3 days prior to randomization
8. WHO-ECOG Performance Status ≤ 2
9. Patients of childbearing/reproductive potential will be instructed to use birth control as defined by your doctor.

Exclusion Criteria-

Among other criteria, patients who meet the following conditions are NOT eligible for the study:

1. Stereotactic biopsy only (without further surgical resection)
2. Presence of diffuse leptomeningeal disease, gliomatosis cerebri, or infratentorial disease.
3. History, presence, or suspicion of metastatic disease
4. Patients who have received any additional treatment for glioblastoma, aside from surgical resection and chemoradiation with temozolomide
5. Active systemic infection requiring treatment
6. History of any malignancy (other than glioblastoma) during the last three years except non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder cancer, cured, early-stage prostate cancer in a patient with PSA level less than ULN,or other carcinoma in situ that has been adequately treated and cured.
7. Planned major surgery
8. Evidence of current drug or alcohol abuse
9. Known allergy or hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF (sargramostim; LEUKINE®), polysorbate 80 or yeast derived products, or a history of anaphylactic reactions to shellfish proteins
10. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with participating in a clinical trial
11. Women who are pregnant or lactating

Primary outcomes:
measure: Overall Survival
timeFrame: During treatment and every three months from end of treatment through end of study or approximately up to 5 years.
Secondary outcomes:
measure: Progression-free survival
timeFrame: Every 12 weeks from Day 1 through progression or initiation of other anti-cancer therapy
measure: Safety and Tolerability
timeFrame: Until day 28 of follow up
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama Mitchell Cancer Institute
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Health Network
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Duarte
country: United States
facility: City of Hope Cancer Center
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center
state: California
city: Redwood City
country: United States
facility: Kaiser Permanente, Redwood City Medical Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford Cancer Institute, Stanford University
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University Medical Center
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center, Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Center Orlando
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Atlanta Cancer Care
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University School of Medicine
state: Georgia
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente Hawaii Moanalua Medical Center
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University Robert H. Lurie Comprehensive Cancer Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Evanston
country: United States
facility: North Shore University Health System
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Waterloo
country: United States
facility: Covenant Clinic / Iowa Spine and Brain Institute
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center, Feist-Weiller Cancer Center
state: Louisiana
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders, PC
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute and Mass General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Lansing
country: United States
facility: Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center
state: Michigan
city: Saginaw
country: United States
facility: St. Mary's of Michigan Medical Center/Field Neurosciences Institute
state: Michigan
city: Minneapolis
country: United States
facility: Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute
state: Minnesota
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Cancer Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Edison
country: United States
facility: New Jersey Neuroscience Institute, JFK Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Long Branch
country: United States
facility: Monmouth Medical Center
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurosciences Research Institute
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Great Neck
country: United States
facility: The Long Island Brain Tumor Center at Neurology Surgery, P.C.
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center - The Neurologic Institute of New York
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: White Plains
country: United States
facility: Brain and Spine Surgeons of New York
state: New York
city: Durham
country: United States
facility: The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Institute
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals, Case Medical Center (Cleveland)
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center, Oncology & Hematology Care
state: Oregon
city: Portland
country: United States
facility: Pacific Neurosurgical
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Physician Group-Hematology-Oncology Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: West Penn. Allegheny Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina - Department of Neuroscience
state: South Carolina
city: Knoxville
country: United States
facility: University of Tennessee Medical Center - Knoxville
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology Midtwon
state: Texas
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Houston
country: United States
facility: The Methodist Neurological Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Department of Neurosurgery
state: Utah
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Healthcare System
state: Virginia
city: Seattle
country: United States
facility: Swedish Neuroscience Institute
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Paul P Carbone Comprehensive Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Westmead
country: Australia
facility: The Crown Princess Mary Cancer Centre, Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Adult Hospital, Mater Misericordiae Health Services Brisbane Limited
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: North Adelaide
country: Australia
facility: Calvary North Adelaide Hospital
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Launceston
country: Australia
facility: Launceston General Hospital
state: Tasmania
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Richmond
country: Australia
facility: Epworth Healthcare
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Innsbruck
country: Austria
facility: Medical University Innsbruck, Dept of Neurology, Anichstrabe 35
city: Vienna
country: Austria
facility: Medizinische Universität Wien, Innere Medizin I, Onkologie
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
state: Antwerp
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus-Centro de Pesquisa em Oncologia Clinica
state: Rio Grande Do Sul
city: Jaú
country: Brazil
facility: Centro de Pesquisas Clinicas da Fundação Dr Amaral Carvalho
state: São Paulo
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de de São José do Rio Preto - Hospital de Base
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Cancer (INCA)
city: Sao Paulo
country: Brazil
facility: Hospital Albert Einstein
city: São Paulo
country: Brazil
facility: Instituto do Câncer do Estado de São Paulo - ICESP
city: São Paulo
country: Brazil
facility: Real e Benemerita Associação Portuguesa de Beneficiência/ Hospital São José
city: São Paulo
country: Brazil
facility: Hospital A C Camargo
city: Calgary
country: Canada
facility: Foothills Hospital Medical Centre
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency, Vancouver Clinic
state: British Columbia
city: Victoria
country: Canada
facility: BC Cancer Agency - Vancouver Island Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba-Cancer Care Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program, London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital, Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame
state: Quebec
city: Montreal
country: Canada
facility: Montreal Neurological Institute and Hospital
state: Quebec
city: Shenbrooke
country: Canada
facility: CHUS Hôpital Fleurimont
state: Quebec
city: Quebec
country: Canada
facility: CHUQ L'Hotel Dieu de Qujebec
city: Bogota
country: Colombia
facility: Fundacion Santa Fe
state: Bogota D.C
city: Ceske Budejovice
country: Czechia
facility: Hospital Ceske Budejovice
city: Prague
country: Czechia
facility: Umiversity Hospital (Fakultni Nemocnice)
city: Prague
country: Czechia
facility: Hospital Na Homolce
city: Praha 5
country: Czechia
facility: Multiscan s.r.o.
city: Usti nad Labem
country: Czechia
facility: Masaryk´s Hospital Usti nad Labem
city: Angers
country: France
facility: Institut de Cancerologie de I'Quest-Paul Papin
city: Bordeaux
country: France
facility: Institute Bergonie
city: Lyon
country: France
facility: Centre Leon Berard de Lyon
city: Montpellier
country: France
facility: ICM Val d'Aurel Montpellier
city: Nantes
country: France
facility: Institut de Cancerologie de L'Quest-Center Rane Gauducheau
city: Paris
country: France
facility: Service de Neurologie-GH
city: Rennes
country: France
facility: Centre Eugene Marquis
city: St Herblain
country: France
facility: Institut de Cancerologie de l'ouest-Center Rene Gauducheau
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Regensburg
country: Germany
facility: Klinik und Poliklinik fur Neurologie der Universitat Regensburg
state: Bavaria
city: Erlangen
country: Germany
facility: Strahlenklinik Universitatsklinikum Erlangen
city: Frankfurt
country: Germany
facility: Dr. Senchkenbergisches Institut fur Neuroonkologie
city: Hamburg
country: Germany
facility: University Hospital Hamburg Kopf und Neurozentrum
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg, Neurologische Klinik, IM Neuenheimer Feld 672
city: Kiel
country: Germany
facility: University Medical Centre
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Munich
country: Germany
facility: LMU Munich
city: Athens
country: Greece
facility: NNA
state: Attiki
city: Marousi
country: Greece
facility: "HYGEIA" Hospital
state: District Of Attica
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet Sugárterápiás Osztály
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Sugárterápiás Osztály
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Általános Orvostudományi Kar
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Onkoterápiás Klinika
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Lajos Általános Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktatókórház Nonprofit Zrt
city: Vijayawada
country: India
facility: City Cancer Centre, Vijayawada
state: Andhra Pradesh
city: Bengaluru
country: India
facility: HCG - Bangalore Institute of Oncology, Bangalore
state: Karnataka
city: Kochi
country: India
facility: Amrita Institute of Medical Sciences and Research Centre, Kochi
state: Kerala
city: Thiruvananthapuram
country: India
facility: Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram
state: Kerala
city: Aurangabad
country: India
facility: Marathwada Regional Cancer Centre and Research Institute - Government
state: Maharashtra
city: Andheri-West
country: India
facility: Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
state: Mumbai
city: Parel
country: India
facility: Tata Memorial Hospital , Mumbai
state: Mumbai
city: Jasola Viha
country: India
facility: Indraprastha Apollo Hospital, New Delhi
state: New Delhi
city: Erandauame
country: India
facility: Sahyadri Hospitals Limited
state: Pune
city: Chennai
country: India
facility: Dr. Rai Memorial Medical Centre, Chennai
state: Tamil Nadu
city: Delhi
country: India
facility: HCG Shanti Mukand Hospital - Curie Cancer Centre, Delhi
city: Beer-Sheva
country: Israel
facility: Soroka University M.C.
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Tel Hashomer
country: Israel
facility: SHEBA Medical Center
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Bologna
country: Italy
facility: UO Oncologie Medica Dipartimento Oncologico
city: Milano
country: Italy
facility: Fondazione IRCCS Instituto Neurologico Carlo Besta
city: Rome
country: Italy
facility: Sacred Heart Catholic University
city: Torino
country: Italy
facility: Universita e AO Citta delia Scienza, Universita Di Torino
city: Mexico
country: Mexico
facility: Grupo Médico Camino S.C.
state: D.F
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara "Fray Antonio Alcalde"
state: Jalisco
city: Culiacán
country: Mexico
facility: Ensayos Clínicos y Medicina de Alta Especialidad, S.C.
state: Sinaloa
city: Durango
country: Mexico
facility: Servicios Medicos de Investigacion Clinica Sc
city: San Luis Potosí
country: Mexico
facility: Hospital Central "Ignacio Morones Prieto"
city: The Hague
country: Netherlands
facility: Medisch Centrum Haaglanden
state: Zuid Holland
city: Amsterdam
country: Netherlands
facility: VUMC
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
city: Christchurch Central
country: New Zealand
facility: Christchurch Hospital
state: Christchurch
city: Roslyn
country: New Zealand
facility: Palmerston North Hospital
state: Palmerston North
city: Hamilton
country: New Zealand
facility: Waikato Hospital, Regional Cancer Centre
state: Waikato District
city: Hamilton
country: New Zealand
facility: Waikato Hospital, Regional Cancer Center
state: Waikato Distric
city: Chiclayo
country: Peru
facility: Hospital Almanzor Aguinaga Asenjo
city: Lima
country: Peru
facility: Instituto Oncologico Miraflores
city: Lima
country: Peru
facility: Clinica Anglo Americana
city: Lima
country: Peru
facility: Clinica Ricardo Palma
city: Lima
country: Peru
facility: Oncosalud
city: LaHospitalet De Lubregat
country: Spain
facility: Institut Catala d Oncologia
state: Catalonia
city: Franca
country: Spain
facility: Dra. Sonia Del Barco Berron, ICO Girona Avda,
state: Girona
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelonia
country: Spain
facility: ICO Badalona-Hospital Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau Medizinische Onkologie Tellstrasse
state: AG
city: Lausanne
country: Switzerland
facility: CHUV, Centre Hospitalier Universitaire Vaudois
state: VD
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland (IOSI)
city: Bern
country: Switzerland
facility: Inselspital, Universitatsspital Bern, Universitatsklinik fur Medizinische Onkologie, Freiburgstrasse
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires de Geneve-HUG-Centre d'Oncologie
city: Zurich
country: Switzerland
facility: Brain Tumor Center, University Hospital Zurich
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
state: Bei District
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou Branch
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan City - Yongkang District
country: Taiwan
facility: Chi Mei Medical Center
city: Taipei city - Neihu District
country: Taiwan
facility: Tri-Service General Hospital
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
city: Patumwan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bankok
city: Amphoe Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
state: Chiang Mai
city: Hat Yai
country: Thailand
facility: Songkhlanagarind Hospital
state: Songkla
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
city: Bristol
country: United Kingdom
facility: The Bristol Haematology and Oncology Centre
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre Western General Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centrel
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS, Westminister Bridge Road
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
Study officials:
References:
citation: Weller M, Butowski N, Tran DD, Recht LD, Lim M, Hirte H, Ashby L, Mechtler L, Goldlust SA, Iwamoto F, Drappatz J, O'Rourke DM, Wong M, Hamilton MG, Finocchiaro G, Perry J, Wick W, Green J, He Y, Turner CD, Yellin MJ, Keler T, Davis TA, Stupp R, Sampson JH; ACT IV trial investigators. Rindopepimut with temozolomide for patients with newly diagnosed, EGFRvIII-expressing glioblastoma (ACT IV): a randomised, double-blind, international phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1373-1385. doi: 10.1016/S1470-2045(17)30517-X. Epub 2017 Aug 23.