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

NCT01480479 | Completed Phase 3 DMC

• 1 other identifier: CDX110-04
• Study Type: interventional
• Target: 745
• Locations: 23 countries
• Sites: 209

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression-free survival

  Every 12 weeks from Day 1 through progression or initiation of other anti-cancer therapy

• Safety and Tolerability

  Until day 28 of follow up

Study Arms (2)

Rindopepimut/GM-CSF plus Temozolomide

EXPERIMENTAL

Drug: Rindopepimut (CDX-110) with GM-CSF; Drug: Temozolomide

KLH plus Temozolomide

ACTIVE COMPARATOR

Drug: Temozolomide; Drug: KLH

Interventions

Rindopepimut (CDX-110) with GM-CSF DRUG

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.

Also known as: CDX-110 with sargramostim (GM-CSF) (Leukine®)

Rindopepimut/GM-CSF plus Temozolomide

Temozolomide DRUG

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.

Also known as: Temodar, Temodal

KLH plus Temozolomide; Rindopepimut/GM-CSF plus Temozolomide

KLH DRUG

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.

KLH plus Temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Among other criteria, patients who meet the following conditions are NOT eligible for the study:
• Stereotactic biopsy only (without further surgical resection)
• Presence of diffuse leptomeningeal disease, gliomatosis cerebri, or infratentorial disease.
• History, presence, or suspicion of metastatic disease
• Patients who have received any additional treatment for glioblastoma, aside from surgical resection and chemoradiation with temozolomide
• Active systemic infection requiring treatment
• 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.
• Planned major surgery
• Evidence of current drug or alcohol abuse
• 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
• Severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with participating in a clinical trial
• Women who are pregnant or lactating

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (223)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

Location

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

Phoenix, Arizona, 85013, United States

Location

University of Arizona Health Network

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

City of Hope Cancer Center

Duarte, California, 91010, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Kaiser Permanente, Redwood City Medical Center

Redwood City, California, 94063, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Stanford Cancer Institute, Stanford University

Stanford, California, 94305, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale University Medical Center

New Haven, Connecticut, 06520, United States

Location

Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Mount Sinai Medical Center, Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

MD Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Atlanta Cancer Care

Atlanta, Georgia, 30005, United States

Location

Winship Cancer Institute, Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Kaiser Permanente Hawaii Moanalua Medical Center

Honolulu, Hawaii, 96819, United States

Location

Northwestern University Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

North Shore University Health System

Evanston, Illinois, 60201, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Covenant Clinic / Iowa Spine and Brain Institute

Waterloo, Iowa, 50702, United States

Location

University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

LSU Health Sciences Center, Feist-Weiller Cancer Center

Shreveport, Louisiana, 71103, United States

Location

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21231, United States

Location

Center for Cancer and Blood Disorders, PC

Bethesda, Maryland, 20817, United States

Location

Dana-Farber Cancer Institute and Mass General Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center

Lansing, Michigan, 48912, United States

Location

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

Saginaw, Michigan, 48604, United States

Location

Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute

Minneapolis, Minnesota, 55407, United States

Location

Ellis Fischel Cancer Center

Columbia, Missouri, 65203, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Southeast Nebraska Cancer Center

Lincoln, Nebraska, 68510, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

New Jersey Neuroscience Institute, JFK Medical Center

Edison, New Jersey, 08818, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

Location

Dent Neurosciences Research Institute

Amherst, New York, 14226, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

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

Great Neck, New York, 11021, United States

Location

North Shore University Hospital

Manhasset, New York, 11030-3186, United States

Location

Columbia University Medical Center - The Neurologic Institute of New York

New York, New York, 10032, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Brain and Spine Surgeons of New York

White Plains, New York, 10604, United States

Location

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

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45267, United States

Location

University Hospitals, Case Medical Center (Cleveland)

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Providence Portland Medical Center, Oncology & Hematology Care

Portland, Oregon, 97213, United States

Location

Pacific Neurosurgical

Portland, Oregon, 97227, United States

Location

Lehigh Valley Physician Group-Hematology-Oncology Associates

Allentown, Pennsylvania, 18103, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

West Penn. Allegheny Health System

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

Medical University of South Carolina - Department of Neuroscience

Charleston, South Carolina, 29425, United States

Location

University of Tennessee Medical Center - Knoxville

Knoxville, Tennessee, 37920, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Texas Oncology Midtwon

Austin, Texas, 78705, United States

Location

Baylor Research Institute

Dallas, Texas, 75246, United States

Location

The Methodist Neurological Institute

Houston, Texas, 77030, United States

Location

University of Utah Department of Neurosurgery

Salt Lake City, Utah, 84112, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05405, United States

Location

University of Virginia Healthcare System

Charlottesville, Virginia, 22908, United States

Location

Swedish Neuroscience Institute

Seattle, Washington, 98122, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

University of Wisconsin Paul P Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2605, Australia

Location

The Crown Princess Mary Cancer Centre, Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Mater Adult Hospital, Mater Misericordiae Health Services Brisbane Limited

South Brisbane, Queensland, 4101, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Calvary North Adelaide Hospital

North Adelaide, South Australia, 5006, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Launceston General Hospital

Launceston, Tasmania, 7250, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3199, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Epworth Healthcare

Richmond, Victoria, 3121, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 06008, Australia

Location

Liverpool Hospital

Liverpool, 2107, Australia

Location

Medical University Innsbruck, Dept of Neurology, Anichstrabe 35

Innsbruck, 6020, Austria

Location

Medizinische Universität Wien, Innere Medizin I, Onkologie

Vienna, 1090, Austria

Location

Universitair Ziekenhuis Antwerpen

Edegem, Antwerp, 2650, Belgium

Location

ZNA Middelheim

Antwerp, B-2020, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

Hospital Mae de Deus-Centro de Pesquisa em Oncologia Clinica

Porto Alegre, Rio Grande do Sul, 90840-440, Brazil

Location

Centro de Pesquisas Clinicas da Fundação Dr Amaral Carvalho

Jaú, São Paulo, 17210-120, Brazil

Location

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

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Instituto Nacional do Cancer (INCA)

Rio de Janeiro, 20231-050, Brazil

Location

Instituto do Câncer do Estado de São Paulo - ICESP

São Paulo, 01246-000, Brazil

Location

Real e Benemerita Associação Portuguesa de Beneficiência/ Hospital São José

São Paulo, 01321-001, Brazil

Location

Hospital A C Camargo

São Paulo, 01509-900, Brazil

Location

Hospital Albert Einstein

São Paulo, 05652-900, Brazil

Location

Foothills Hospital Medical Centre

Calgary, Alberta, T3J 5N6, Canada

Location

British Columbia Cancer Agency, Vancouver Clinic

Vancouver, British Columbia, V5Z 4E6, Canada

Location

BC Cancer Agency - Vancouver Island Centre

Victoria, British Columbia, V8X 4V6, Canada

Location

University of Manitoba-Cancer Care Manitoba

Winnipeg, Manitoba, R3E0V9, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program, London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital, Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

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

Montreal, Quebec, H2L 4M1, Canada

Location

Montreal Neurological Institute and Hospital

Montreal, Quebec, H3A 2B4, Canada

Location

CHUQ L'Hotel Dieu de Qujebec

Québec, Quebec, G1R 2J6, Canada

Location

CHUS Hôpital Fleurimont

Shenbrooke, Quebec, J1H5N4, Canada

Location

Fundacion Santa Fe

Bogotá, Bogota D.C., 000, Colombia

Location

Hospital Ceske Budejovice

České Budějovice, 370 01, Czechia

Location

Umiversity Hospital (Fakultni Nemocnice)

Prague, 150 06, Czechia

Location

Hospital Na Homolce

Prague, 150 30, Czechia

Location

Multiscan s.r.o.

Prague, 155-00, Czechia

Location

Masaryk´s Hospital Usti nad Labem

Ústí nad Labem, 401-13, Czechia

Location

Institut de Cancerologie de I'Quest-Paul Papin

Angers, 49933, France

Location

Institute Bergonie

Bordeaux, 33076, France

Location

Centre Leon Berard de Lyon

Lyon, 69373, France

Location

ICM Val d'Aurel Montpellier

Montpellier, 342298, France

Location

Institut de Cancerologie de L'Quest-Center Rane Gauducheau

Nantes, 44805, France

Location

Service de Neurologie-GH

Paris, 75013, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Institut de Cancerologie de l'ouest-Center Rene Gauducheau

Saint-Herblain, 44805, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Klinik und Poliklinik fur Neurologie der Universitat Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Strahlenklinik Universitatsklinikum Erlangen

Erlangen, D-91054, Germany

Location

Dr. Senchkenbergisches Institut fur Neuroonkologie

Frankfurt, D-60528, Germany

Location

University Hospital Hamburg Kopf und Neurozentrum

Hamburg, 20246, Germany

Location

Universitaetsklinikum Heidelberg, Neurologische Klinik, IM Neuenheimer Feld 672

Heidelberg, 69120, Germany

Location

University Medical Centre

Kiel, 24105, Germany

Location

LMU Munich

Munich, D-81377, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

NNA

Athens, Attica, 11521, Greece

Location

"HYGEIA" Hospital

Marousi, District of Attica, 151 23, Greece

Location

Országos Onkológiai Intézet Sugárterápiás Osztály

Budapest, 1122, Hungary

Location

Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet

Debrecen, 4032, Hungary

Location

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

Miskolc, 3526, Hungary

Location

Pécsi Tudományegyetem Általános Orvostudományi Kar

Pécs, 7624, Hungary

Location

Szegedi Tudományegyetem Onkoterápiás Klinika

Szeged, 6720, Hungary

Location

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

Szombathely, 9700, Hungary

Location

City Cancer Centre, Vijayawada

Vijayawada, Andhra Pradesh, 520002, India

Location

HCG - Bangalore Institute of Oncology, Bangalore

Bengaluru, Karnataka, 560027, India

Location

Amrita Institute of Medical Sciences and Research Centre, Kochi

Kochi, Kerala, 682 026, India

Location

Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram

Thiruvananthapuram, Kerala, 695 011, India

Location

Marathwada Regional Cancer Centre and Research Institute - Government

Aurangabad, Maharashtra, 431001, India

Location

Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute

Andheri-West, Mumbai, 400 053, India

Location

Tata Memorial Hospital , Mumbai

Pārel, Mumbai, 400012, India

Location

Indraprastha Apollo Hospital, New Delhi

Jasola Viha, New Delhi, 110076, India

Location

Sahyadri Hospitals Limited

Erandauame, Pune, 411004, India

Location

Dr. Rai Memorial Medical Centre, Chennai

Chennai, Tamil Nadu, 600018, India

Location

HCG Shanti Mukand Hospital - Curie Cancer Centre, Delhi

Delhi, 110092, India

Location

Soroka University M.C.

Beersheba, 84101, Israel

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

SHEBA Medical Center

Tel Litwinsky, 52126, Israel

Location

UO Oncologie Medica Dipartimento Oncologico

Bologna, 40139, Italy

Location

Fondazione IRCCS Instituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

Sacred Heart Catholic University

Rome, 00168, Italy

Location

Universita e AO Citta delia Scienza, Universita Di Torino

Torino, 10126, Italy

Location

Grupo Médico Camino S.C.

México, D.F, 03310, Mexico

Location

Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, 34000, Mexico

Location

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

Culiacán, Sinaloa, 80020, Mexico

Location

Servicios Medicos de Investigacion Clinica Sc

Durango, 34000, Mexico

Location

Hospital Central "Ignacio Morones Prieto"

San Luis Potosí City, 78240, Mexico

Location

Medisch Centrum Haaglanden

The Hague, South Holland, 2512 VA, Netherlands

Location

VUMC

Amsterdam, 1081HV, Netherlands

Location

Radboud University Nijmegen Medical Center

Nijmegen, 6525 GA, Netherlands

Location

Christchurch Hospital

Christchurch Central, Christchurch, 8011, New Zealand

Location

Palmerston North Hospital

Roslyn, Palmerston North, 4414, New Zealand

Location

Waikato Hospital, Regional Cancer Centre

Hamilton, Waikato District, 3240, New Zealand

Location

Waikato Hospital, Regional Cancer Center

Hamilton, Waikato Distric, 3240, New Zealand

Location

Hospital Almanzor Aguinaga Asenjo

Chiclayo, Peru

Location

Instituto Oncologico Miraflores

Lima, Lima 18, Peru

Location

Clinica Anglo Americana

Lima, Lima 27, Peru

Location

Clinica Ricardo Palma

Lima, Lima 27, Peru

Location

Oncosalud

Lima, Lima 41, Peru

Location

Institut Catala d Oncologia

LaHospitalet de Lubregat, Catalonia, 08908, Spain

Location

Dra. Sonia Del Barco Berron, ICO Girona Avda,

Franca, Girona, 17007, Spain

Location

Hospital Clinic

Barcelona, 8036, Spain

Location

ICO Badalona-Hospital Germans Trias i Pujol

Barcelonia, 08916, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Kantonsspital Aarau Medizinische Onkologie Tellstrasse

Aarau, Canton of Aargau, 5001, Switzerland

Location

CHUV, Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, 6500, Switzerland

Location

Inselspital, Universitatsspital Bern, Universitatsklinik fur Medizinische Onkologie, Freiburgstrasse

Bern, 3010, Switzerland

Location

Hopitaux Universitaires de Geneve-HUG-Centre d'Oncologie

Geneva, 1211, Switzerland

Location

Brain Tumor Center, University Hospital Zurich

Zurich, 8091, Switzerland

Location

National Cheng Kung University Hospital

Tainan, Bei District, 704, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Chang Gung Memorial Hospital Linkou Branch

Taichung, 40705, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Chi Mei Medical Center

Tainan City - Yongkang District, 710, Taiwan

Location

Tri-Service General Hospital

Taipei City - Neihu District, 00114, Taiwan

Location

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

King Chulalongkorn Memorial Hospital

Patumwan, Bankok, 10330, Thailand

Location

Songkhlanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Amphoe Muang, Chiang Mai, 50200, Thailand

Location

Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

The Bristol Haematology and Oncology Centre

Bristol, BS2 8ED, United Kingdom

Location

Edinburgh Cancer Centre Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Beatson West of Scotland Cancer Centrel

Glasgow, G12 0NY, United Kingdom

Location

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

London, SE17EH, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 28844499 RESULT

• Seliger C, Oppong FB, Lefranc F, Chinot O, Stupp R, Nabors B, Gorlia T, Weller M; EORTC Brain Tumor Group. Association of antidepressant drug use with outcome of patients with glioblastoma. Int J Cancer. 2023 Apr 1;152(7):1348-1359. doi: 10.1002/ijc.34344. Epub 2022 Nov 17.

  PMID: 36346112 DERIVED

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma; Brain Neoplasms; Neoplasms

Interventions

rindopepimut; sargramostim; Granulocyte-Macrophage Colony-Stimulating Factor; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 29, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 16, 2018

Record last verified: 2017-04

Locations

GB (6); AU (2); BR (8); TH (4); ES (5); DE (8); ME (5); NL (3); US (88); GR (2); PE (5); TW (6); FR (9); IN (11); NZ (4); HU (6); CH (6); BE (3); CA (13); CO (1); CZ (5); IL (5); IT (4)