Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma (ACT IV)

An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma

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.

Study Overview

• Status: Completed
• Conditions: Glioblastoma; Gliosarcoma; Small Cell Glioblastoma; Giant Cell Glioblastoma; Glioblastoma With Oligodendroglial Component
• Intervention / Treatment: Drug: Rindopepimut (CDX-110) with GM-CSF; Drug: Temozolomide; Drug: KLH

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.

• Study Type: Interventional
• Enrollment (Actual): 745
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Liverpool, Australia, 2107
    • Liverpool Hospital
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Hospital
    • St Leonards, New South Wales, Australia, 2605
      • Royal North Shore Hospital
    • Westmead, New South Wales, Australia, 2145
      • The Crown Princess Mary Cancer Centre, Westmead Hospital
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women'S Hospital
    • South Brisbane, Queensland, Australia, 4101
      • Mater Adult Hospital, Mater Misericordiae Health Services Brisbane Limited
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
    • North Adelaide, South Australia, Australia, 5006
      • Calvary North Adelaide Hospital
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital
    • Launceston, Tasmania, Australia, 7250
      • Launceston General Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3199
      • Monash Medical Centre
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
    • Richmond, Victoria, Australia, 3121
      • Epworth Healthcare
  • Western Australia
    • Nedlands, Western Australia, Australia, 06008
      • Sir Charles Gairdner Hospital
• Austria
  • Innsbruck, Austria, 6020
    • Medical University Innsbruck, Dept of Neurology, Anichstrabe 35
  • Vienna, Austria, 1090
    • Medizinische Universität Wien, Innere Medizin I, Onkologie
• Belgium
  • Antwerpen, Belgium, B-2020
    • ZNA Middelheim
  • Ghent, Belgium, 9000
    • Ghent University Hospital
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Universitair Ziekenhuis Antwerpen
• Brazil
  • Rio de Janeiro, Brazil, 20231-050
    • Instituto Nacional Do Cancer (INCA)
  • Sao Paulo, Brazil, 05652-900
    • Hospital Albert Einstein
  • São Paulo, Brazil, 01246-000
    • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • São Paulo, Brazil, 01321-001
    • Real e Benemerita Associação Portuguesa de Beneficiência/ Hospital São José
  • São Paulo, Brazil, 01509-900
    • Hospital A C Camargo
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90840-440
      • Hospital Mae de Deus-Centro de Pesquisa em Oncologia Clinica
  • São Paulo
    • Jaú, São Paulo, Brazil, 17210-120
      • Centro de Pesquisas Clinicas da Fundação Dr Amaral Carvalho
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Fundação Faculdade Regional de Medicina de de São José do Rio Preto - Hospital de Base
• Canada
  • Quebec, Canada, G1R 2J6
    • CHUQ L'Hotel Dieu de Qujebec
  • Alberta
    • Calgary, Alberta, Canada, T3J 5N6
      • Foothills Hospital Medical Centre
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency, Vancouver Clinic
    • Victoria, British Columbia, Canada, V8X 4V6
      • BC Cancer Agency - Vancouver Island Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E0V9
      • University of Manitoba-Cancer Care Manitoba
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • QEII Health Sciences Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Program, London Health Sciences Centre
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital, Regional Cancer Centre
    • Toronto, Ontario, Canada, M4N3M5
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H3A 2B4
      • Montreal Neurological Institute and Hospital
    • Montreal, Quebec, Canada, H2L 4M1
      • Centre Hospitalier de l'Universite de Montreal (Chum) - Hopital Notre-Dame
    • Shenbrooke, Quebec, Canada, J1H5N4
      • CHUS Hopital Fleurimont
• Colombia
  • Bogota D.C
    • Bogota, Bogota D.C, Colombia, 000
      • Fundacion Santa Fe
• Czechia
  • Ceske Budejovice, Czechia, 370 01
    • Hospital České Budějovice
  • Prague, Czechia, 150 06
    • Umiversity Hospital (Fakultni Nemocnice)
  • Prague, Czechia, 150 30
    • Hospital Na Homolce
  • Praha 5, Czechia, 155-00
    • Multiscan s.r.o.
  • Usti nad Labem, Czechia, 401-13
    • Masaryk´s Hospital Ústí nad Labem
• France
  • Angers, France, 49933
    • Institut de Cancerologie de I'Quest-Paul Papin
  • Bordeaux, France, 33076
    • Institute Bergonie
  • Lyon, France, 69373
    • Centre Léon Bérard de LYON
  • Montpellier, France, 342298
    • ICM Val d'Aurel Montpellier
  • Nantes, France, 44805
    • Institut de Cancerologie de L'Quest-Center Rane Gauducheau
  • Paris, France, 75013
    • Service de Neurologie-GH
  • Rennes, France, 35042
    • Centre Eugene Marquis
  • St Herblain, France, 44805
    • Institut de Cancerologie de l'ouest-Center Rene Gauducheau
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Germany
  • Erlangen, Germany, D-91054
    • Strahlenklinik Universitatsklinikum Erlangen
  • Frankfurt, Germany, D-60528
    • Dr. Senchkenbergisches Institut fur Neuroonkologie
  • Hamburg, Germany, 20246
    • University Hospital Hamburg Kopf und Neurozentrum
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg, Neurologische Klinik, IM Neuenheimer Feld 672
  • Kiel, Germany, 24105
    • University Medical Centre
  • Muenster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Munich, Germany, D-81377
    • LMU Munich
  • Bavaria
    • Regensburg, Bavaria, Germany, 93053
      • Klinik und Poliklinik für Neurologie der Universität Regensburg
• Greece
  • Attiki
    • Athens, Attiki, Greece, 11521
      • NNA
  • District Of Attica
    • Marousi, District Of Attica, Greece, 151 23
      • "HYGEIA" Hospital
• Hungary
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet Sugarterapias Osztaly
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet
  • Miskolc, Hungary, 3526
    • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Sugárterápiás Osztály
  • Pécs, Hungary, 7624
    • Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem Onkoterapias Klinika
  • Szombathely, Hungary, 9700
    • Vas Megyei Markusovszky Lajos Általános Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktatókórház Nonprofit Zrt
• India
  • Delhi, India, 110092
    • HCG Shanti Mukand Hospital - Curie Cancer Centre, Delhi
  • Andhra Pradesh
    • Vijayawada, Andhra Pradesh, India, 520002
      • City Cancer Centre, Vijayawada
  • Karnataka
    • Bengaluru, Karnataka, India, 560027
      • HCG - Bangalore Institute of Oncology, Bangalore
  • Kerala
    • Kochi, Kerala, India, 682 026
      • Amrita Institute of Medical Sciences and Research Centre, Kochi
    • Thiruvananthapuram, Kerala, India, 695 011
      • Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram
  • Maharashtra
    • Aurangabad, Maharashtra, India, 431001
      • Marathwada Regional Cancer Centre and Research Institute - Government
  • Mumbai
    • Andheri-West, Mumbai, India, 400 053
      • Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
    • Parel, Mumbai, India, 400012
      • TATA MEMORIAL HOSPITAL , MUMBAI
  • New Delhi
    • Jasola Viha, New Delhi, India, 110076
      • Indraprastha Apollo Hospital, New Delhi
  • Pune
    • Erandauame, Pune, India, 411004
      • Sahyadri Hospitals Limited
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600018
      • Dr. Rai Memorial Medical Centre, Chennai
• Israel
  • Beer-Sheva, Israel, 84101
    • Soroka University M.C.
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center
  • Tel Hashomer, Israel, 52126
    • Sheba Medical Center
  • Tel-Aviv, Israel, 64239
    • Tel-Aviv Sourasky Medical Center
• Italy
  • Bologna, Italy, 40139
    • UO Oncologie Medica Dipartimento Oncologico
  • Milano, Italy, 20133
    • Fondazione IRCCS Instituto Neurologico Carlo Besta
  • Rome, Italy, 00168
    • Sacred Heart Catholic University
  • Torino, Italy, 10126
    • Universita e AO Citta delia Scienza, Universita Di Torino
• Mexico
  • Durango, Mexico, 34000
    • Servicios Medicos de Investigacion Clinica Sc
  • San Luis Potosí, Mexico, 78240
    • Hospital Central "Ignacio Morones Prieto"
  • D.F
    • Mexico, D.F, Mexico, 03310
      • Grupo Medico Camino S.C.
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 34000
      • Hospital Civil de Guadalajara "Fray Antonio Alcalde"
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80020
      • Ensayos Clínicos y Medicina de Alta Especialidad, S.C.
• Netherlands
  • Amsterdam, Netherlands, 1081HV
    • VUMC
  • Nijmegen, Netherlands, 6525 GA
    • Radboud University Nijmegen Medical Center
  • Zuid Holland
    • The Hague, Zuid Holland, Netherlands, 2512 VA
      • Medisch Centrum Haaglanden
• New Zealand
  • Christchurch
    • Christchurch Central, Christchurch, New Zealand, 8011
      • Christchurch Hospital
  • Palmerston North
    • Roslyn, Palmerston North, New Zealand, 4414
      • Palmerston North Hospital
  • Waikato Distric
    • Hamilton, Waikato Distric, New Zealand, 3240
      • Waikato Hospital, Regional Cancer Center
  • Waikato District
    • Hamilton, Waikato District, New Zealand, 3240
      • Waikato Hospital, Regional Cancer Centre
• Peru
  • Chiclayo, Peru
    • Hospital Almanzor Aguinaga Asenjo
  • Lima, Peru, Lima 18
    • Instituto Oncologico Miraflores
  • Lima, Peru, Lima 27
    • Clinica Anglo Americana
  • Lima, Peru, Lima 27
    • Clinica Ricardo Palma
  • Lima, Peru, Lima 41
    • Oncosalud
• Spain
  • Barcelona, Spain, 8036
    • Hospital Clinic
  • Barcelonia, Spain, 08916
    • ICO Badalona-Hospital Germans Trias i Pujol
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre
  • Catalonia
    • LaHospitalet De Lubregat, Catalonia, Spain, 08908
      • Institut Catala D Oncologia
  • Girona
    • Franca, Girona, Spain, 17007
      • Dra. Sonia Del Barco Berron, ICO Girona Avda,
• Switzerland
  • Bellinzona, Switzerland, 6500
    • Oncology Institute of Southern Switzerland (IOSI)
  • Bern, Switzerland, 3010
    • Inselspital, Universitatsspital Bern, Universitatsklinik fur Medizinische Onkologie, Freiburgstrasse
  • Geneva, Switzerland, 1211
    • Hopitaux Universitaires de Geneve-HUG-Centre d'Oncologie
  • Zurich, Switzerland, 8091
    • Brain Tumor Center, University Hospital Zurich
  • AG
    • Aarau, AG, Switzerland, 5001
      • Kantonsspital Aarau Medizinische Onkologie Tellstrasse
  • VD
    • Lausanne, VD, Switzerland, 1011
      • CHUV, Centre Hospitalier Universitaire Vaudois
• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 40705
    • Chang Gung Memorial Hospital Linkou Branch
  • Tainan City - Yongkang District, Taiwan, 710
    • Chi Mei Medical Center
  • Taipei city - Neihu District, Taiwan, 00114
    • Tri-Service General Hospital
  • Bei District
    • Tainan City, Bei District, Taiwan, 704
      • National Cheng Kung University Hospital
• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Siriraj Hospital
  • Bankok
    • Patumwan, Bankok, Thailand, 10330
      • King Chulalongkorn Memorial Hospital
  • Chiang Mai
    • Amphoe Muang, Chiang Mai, Thailand, 50200
      • Maharaj Nakorn Chiang Mai Hospital
  • Songkla
    • Hat Yai, Songkla, Thailand, 90110
      • Songkhlanagarind Hospital
• United Kingdom
  • Bristol, United Kingdom, BS2 8ED
    • The Bristol Haematology and Oncology Centre
  • Edinburgh, United Kingdom, EH4 2XU
    • Edinburgh Cancer Centre Western General Hospital
  • Glasgow, United Kingdom, G12 0NY
    • Beatson West of Scotland Cancer Centrel
  • London, United Kingdom, SE17EH
    • Guy's and St Thomas' NHS, Westminister Bridge Road
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Royal Marsden NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Mobile, Alabama, United States, 36604
      • University of South Alabama Mitchell Cancer Institute
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
    • Tucson, Arizona, United States, 85724
      • University of Arizona Health Network
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Duarte, California, United States, 91010
      • City of Hope Cancer Center
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • Los Angeles, California, United States, 90033
      • USC Norris Comprehensive Cancer Center
    • Orange, California, United States, 92868
      • Chao Family Comprehensive Cancer Center
    • Redwood City, California, United States, 94063
      • Kaiser Permanente, Redwood City Medical Center
    • Sacramento, California, United States, 95817
      • University of California, Davis
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
    • Stanford, California, United States, 94305
      • Stanford Cancer Institute, Stanford University
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
    • New Haven, Connecticut, United States, 06520
      • Yale University Medical Center
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Health Services
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center, Comprehensive Cancer Center
    • Orlando, Florida, United States, 32806
      • MD Anderson Cancer Center Orlando
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30005
      • Atlanta Cancer Care
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute, Emory University School of Medicine
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Permanente Hawaii Moanalua Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60611
      • Northwestern University Robert H. Lurie Comprehensive Cancer Center
    • Evanston, Illinois, United States, 60201
      • North Shore University Health System
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Iowa
    • Waterloo, Iowa, United States, 50702
      • Covenant Clinic / Iowa Spine and Brain Institute
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0093
      • University of Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Mary Bird Perkins Cancer Center
    • Shreveport, Louisiana, United States, 71103
      • LSU Health Sciences Center, Feist-Weiller Cancer Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins University School of Medicine
    • Bethesda, Maryland, United States, 20817
      • Center for Cancer and Blood Disorders, PC
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute and Mass General Hospital
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Memorial Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
    • Lansing, Michigan, United States, 48912
      • Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center
    • Saginaw, Michigan, United States, 48604
      • St. Mary's of Michigan Medical Center/Field Neurosciences Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Southeast Nebraska Cancer Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New Jersey
    • Edison, New Jersey, United States, 08818
      • New Jersey Neuroscience Institute, JFK Medical Center
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack University Medical Center
    • Long Branch, New Jersey, United States, 07740
      • Monmouth Medical Center
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Institute
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Brooklyn, New York, United States, 11215
      • New York Methodist Hospital
    • Great Neck, New York, United States, 11021
      • The Long Island Brain Tumor Center at Neurology Surgery, P.C.
    • Manhasset, New York, United States, 11030-3186
      • North Shore University Hospital
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • New York, New York, United States, 10032
      • Columbia University Medical Center - The Neurologic Institute of New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
    • White Plains, New York, United States, 10604
      • Brain and Spine Surgeons of New York
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Cancer Institute
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44106
      • University Hospitals, Case Medical Center (Cleveland)
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center, Oncology & Hematology Care
    • Portland, Oregon, United States, 97227
      • Pacific Neurosurgical
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Physician Group-Hematology-Oncology Associates
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Cancer Institute
    • Pittsburgh, Pennsylvania, United States, 15212
      • West Penn. Allegheny Health System
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina - Department of Neuroscience
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center - Knoxville
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Oncology Midtwon
    • Dallas, Texas, United States, 75246
      • Baylor Research Institute
    • Houston, Texas, United States, 77030
      • the Methodist Neurological Institute
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah Department of Neurosurgery
  • Vermont
    • Burlington, Vermont, United States, 05405
      • Fletcher Allen Health Care
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Healthcare System
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Seattle, Washington, United States, 98122
      • Swedish Neuroscience Institute
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Paul P Carbone Comprehensive Cancer Center
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rindopepimut/GM-CSF plus Temozolomide	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.; Other Names: CDX-110 with sargramostim (GM-CSF) (Leukine®); 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.; Other Names: Temodar; Temodal
Active Comparator: KLH plus Temozolomide	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.; Other Names: Temodar; Temodal; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	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.	During treatment and every three months from end of treatment through end of study or approximately up to 5 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Compare progression-free survival between the two treatment arms	Every 12 weeks from Day 1 through progression or initiation of other anti-cancer therapy
Safety and Tolerability	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	Until day 28 of follow up

Collaborators and Investigators

• Sponsor: Celldex Therapeutics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: November 21, 2011
• First Submitted That Met QC Criteria: November 28, 2011
• First Posted (Estimate): November 29, 2011

Study Record Updates

• Last Update Posted (Actual): January 16, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: radiotherapy; Brain Tumor; Gliosarcoma; Glioblastoma; Brain Cancer; chemoradiation; EGFRvIII; Small cell; Giant cell; oligodendroglial; Tumor; EGFR variant III; temozolomide
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Gliosarcoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Immunological; Temozolomide; Sargramostim; Rindopepimut; Molgramostim
• Other Study ID Numbers: CDX110-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No