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

NCT ID: NCT01480479

Last Updated: 2018-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

745 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioblastoma Small Cell Glioblastoma Giant Cell Glioblastoma Gliosarcoma Glioblastoma With Oligodendroglial Component

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rindopepimut/GM-CSF plus Temozolomide

Group Type EXPERIMENTAL

Rindopepimut (CDX-110) with GM-CSF

Intervention Type 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.

Temozolomide

Intervention Type 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.

KLH plus Temozolomide

Group Type ACTIVE_COMPARATOR

Temozolomide

Intervention Type 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.

KLH

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CDX-110 with sargramostim (GM-CSF) (Leukine®) Temodar Temodal

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Celldex Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Site Status

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

Phoenix, Arizona, United States

Site Status

University of Arizona Health Network

Tucson, Arizona, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

City of Hope Cancer Center

Duarte, California, United States

Site Status

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status

Kaiser Permanente, Redwood City Medical Center

Redwood City, California, United States

Site Status

University of California, Davis

Sacramento, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Stanford Cancer Institute, Stanford University

Stanford, California, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

Yale University Medical Center

New Haven, Connecticut, United States

Site Status

Christiana Care Health Services

Newark, Delaware, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Mount Sinai Medical Center, Comprehensive Cancer Center

Miami Beach, Florida, United States

Site Status

MD Anderson Cancer Center Orlando

Orlando, Florida, United States

Site Status

Tampa General Hospital

Tampa, Florida, United States

Site Status

Atlanta Cancer Care

Atlanta, Georgia, United States

Site Status

Winship Cancer Institute, Emory University School of Medicine

Atlanta, Georgia, United States

Site Status

Georgia Regents University

Augusta, Georgia, United States

Site Status

Kaiser Permanente Hawaii Moanalua Medical Center

Honolulu, Hawaii, United States

Site Status

Northwestern University Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

North Shore University Health System

Evanston, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Covenant Clinic / Iowa Spine and Brain Institute

Waterloo, Iowa, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Norton Cancer Institute

Louisville, Kentucky, United States

Site Status

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Site Status

LSU Health Sciences Center, Feist-Weiller Cancer Center

Shreveport, Louisiana, United States

Site Status

Anne Arundel Medical Center

Annapolis, Maryland, United States

Site Status

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

Center for Cancer and Blood Disorders, PC

Bethesda, Maryland, United States

Site Status

Dana-Farber Cancer Institute and Mass General Hospital

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

Site Status

University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center

Lansing, Michigan, United States

Site Status

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

Saginaw, Michigan, United States

Site Status

Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute

Minneapolis, Minnesota, United States

Site Status

Ellis Fischel Cancer Center

Columbia, Missouri, United States

Site Status

Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Southeast Nebraska Cancer Center

Lincoln, Nebraska, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

New Jersey Neuroscience Institute, JFK Medical Center

Edison, New Jersey, United States

Site Status

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Monmouth Medical Center

Long Branch, New Jersey, United States

Site Status

Dent Neurosciences Research Institute

Amherst, New York, United States

Site Status

New York Methodist Hospital

Brooklyn, New York, United States

Site Status

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

Great Neck, New York, United States

Site Status

North Shore University Hospital

Manhasset, New York, United States

Site Status

Columbia University Medical Center - The Neurologic Institute of New York

New York, New York, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Brain and Spine Surgeons of New York

White Plains, New York, United States

Site Status

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

Durham, North Carolina, United States

Site Status

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Site Status

University of Cincinnati Cancer Institute

Cincinnati, Ohio, United States

Site Status

University Hospitals, Case Medical Center (Cleveland)

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Providence Portland Medical Center, Oncology & Hematology Care

Portland, Oregon, United States

Site Status

Pacific Neurosurgical

Portland, Oregon, United States

Site Status

Lehigh Valley Physician Group-Hematology-Oncology Associates

Allentown, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

West Penn. Allegheny Health System

Pittsburgh, Pennsylvania, United States

Site Status

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina - Department of Neuroscience

Charleston, South Carolina, United States

Site Status

University of Tennessee Medical Center - Knoxville

Knoxville, Tennessee, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Texas Oncology Midtwon

Austin, Texas, United States

Site Status

Baylor Research Institute

Dallas, Texas, United States

Site Status

The Methodist Neurological Institute

Houston, Texas, United States

Site Status

University of Utah Department of Neurosurgery

Salt Lake City, Utah, United States

Site Status

Fletcher Allen Health Care

Burlington, Vermont, United States

Site Status

University of Virginia Healthcare System

Charlottesville, Virginia, United States

Site Status

Swedish Neuroscience Institute

Seattle, Washington, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

University of Wisconsin Paul P Carbone Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Prince of Wales Hospital

Randwick, New South Wales, Australia

Site Status

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Site Status

The Crown Princess Mary Cancer Centre, Westmead Hospital

Westmead, New South Wales, Australia

Site Status

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Site Status

Mater Adult Hospital, Mater Misericordiae Health Services Brisbane Limited

South Brisbane, Queensland, Australia

Site Status

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Calvary North Adelaide Hospital

North Adelaide, South Australia, Australia

Site Status

Royal Hobart Hospital

Hobart, Tasmania, Australia

Site Status

Launceston General Hospital

Launceston, Tasmania, Australia

Site Status

Monash Medical Centre

Clayton, Victoria, Australia

Site Status

Austin Health

Heidelberg, Victoria, Australia

Site Status

Epworth Healthcare

Richmond, Victoria, Australia

Site Status

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Site Status

Liverpool Hospital

Liverpool, , Australia

Site Status

Medical University Innsbruck, Dept of Neurology, Anichstrabe 35

Innsbruck, , Austria

Site Status

Medizinische Universität Wien, Innere Medizin I, Onkologie

Vienna, , Austria

Site Status

Universitair Ziekenhuis Antwerpen

Edegem, Antwerp, Belgium

Site Status

ZNA Middelheim

Antwerp, , Belgium

Site Status

Ghent University Hospital

Ghent, , Belgium

Site Status

Hospital Mae de Deus-Centro de Pesquisa em Oncologia Clinica

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Centro de Pesquisas Clinicas da Fundação Dr Amaral Carvalho

Jaú, São Paulo, Brazil

Site Status

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

São José do Rio Preto, São Paulo, Brazil

Site Status

Instituto Nacional do Cancer (INCA)

Rio de Janeiro, , Brazil

Site Status

Instituto do Câncer do Estado de São Paulo - ICESP

São Paulo, , Brazil

Site Status

Real e Benemerita Associação Portuguesa de Beneficiência/ Hospital São José

São Paulo, , Brazil

Site Status

Hospital A C Camargo

São Paulo, , Brazil

Site Status

Hospital Albert Einstein

São Paulo, , Brazil

Site Status

Foothills Hospital Medical Centre

Calgary, Alberta, Canada

Site Status

British Columbia Cancer Agency, Vancouver Clinic

Vancouver, British Columbia, Canada

Site Status

BC Cancer Agency - Vancouver Island Centre

Victoria, British Columbia, Canada

Site Status

University of Manitoba-Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Site Status

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status

London Regional Cancer Program, London Health Sciences Centre

London, Ontario, Canada

Site Status

Ottawa Hospital, Regional Cancer Centre

Ottawa, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

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

Montreal, Quebec, Canada

Site Status

Montreal Neurological Institute and Hospital

Montreal, Quebec, Canada

Site Status

CHUQ L'Hotel Dieu de Qujebec

Québec, Quebec, Canada

Site Status

CHUS Hôpital Fleurimont

Shenbrooke, Quebec, Canada

Site Status

Fundacion Santa Fe

Bogotá, Bogota D.C., Colombia

Site Status

Hospital Ceske Budejovice

České Budějovice, , Czechia

Site Status

Umiversity Hospital (Fakultni Nemocnice)

Prague, , Czechia

Site Status

Hospital Na Homolce

Prague, , Czechia

Site Status

Multiscan s.r.o.

Prague, , Czechia

Site Status

Masaryk´s Hospital Usti nad Labem

Ústí nad Labem, , Czechia

Site Status

Institut de Cancerologie de I'Quest-Paul Papin

Angers, , France

Site Status

Institute Bergonie

Bordeaux, , France

Site Status

Centre Leon Berard de Lyon

Lyon, , France

Site Status

ICM Val d'Aurel Montpellier

Montpellier, , France

Site Status

Institut de Cancerologie de L'Quest-Center Rane Gauducheau

Nantes, , France

Site Status

Service de Neurologie-GH

Paris, , France

Site Status

Centre Eugene Marquis

Rennes, , France

Site Status

Institut de Cancerologie de l'ouest-Center Rene Gauducheau

Saint-Herblain, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Klinik und Poliklinik fur Neurologie der Universitat Regensburg

Regensburg, Bavaria, Germany

Site Status

Strahlenklinik Universitatsklinikum Erlangen

Erlangen, , Germany

Site Status

Dr. Senchkenbergisches Institut fur Neuroonkologie

Frankfurt, , Germany

Site Status

University Hospital Hamburg Kopf und Neurozentrum

Hamburg, , Germany

Site Status

Universitaetsklinikum Heidelberg, Neurologische Klinik, IM Neuenheimer Feld 672

Heidelberg, , Germany

Site Status

University Medical Centre

Kiel, , Germany

Site Status

LMU Munich

Munich, , Germany

Site Status

Universitaetsklinikum Muenster

Münster, , Germany

Site Status

NNA

Athens, Attica, Greece

Site Status

"HYGEIA" Hospital

Marousi, District of Attica, Greece

Site Status

Országos Onkológiai Intézet Sugárterápiás Osztály

Budapest, , Hungary

Site Status

Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet

Debrecen, , Hungary

Site Status

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

Miskolc, , Hungary

Site Status

Pécsi Tudományegyetem Általános Orvostudományi Kar

Pécs, , Hungary

Site Status

Szegedi Tudományegyetem Onkoterápiás Klinika

Szeged, , Hungary

Site Status

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

Szombathely, , Hungary

Site Status

City Cancer Centre, Vijayawada

Vijayawada, Andhra Pradesh, India

Site Status

HCG - Bangalore Institute of Oncology, Bangalore

Bengaluru, Karnataka, India

Site Status

Amrita Institute of Medical Sciences and Research Centre, Kochi

Kochi, Kerala, India

Site Status

Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram

Thiruvananthapuram, Kerala, India

Site Status

Marathwada Regional Cancer Centre and Research Institute - Government

Aurangabad, Maharashtra, India

Site Status

Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute

Andheri-West, Mumbai, India

Site Status

Tata Memorial Hospital , Mumbai

Pārel, Mumbai, India

Site Status

Indraprastha Apollo Hospital, New Delhi

Jasola Viha, New Delhi, India

Site Status

Sahyadri Hospitals Limited

Erandauame, Pune, India

Site Status

Dr. Rai Memorial Medical Centre, Chennai

Chennai, Tamil Nadu, India

Site Status

HCG Shanti Mukand Hospital - Curie Cancer Centre, Delhi

Delhi, , India

Site Status

Soroka University M.C.

Beersheba, , Israel

Site Status

Rambam Health Care Campus

Haifa, , Israel

Site Status

Hadassah Medical Center

Jerusalem, , Israel

Site Status

Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

SHEBA Medical Center

Tel Litwinsky, , Israel

Site Status

UO Oncologie Medica Dipartimento Oncologico

Bologna, , Italy

Site Status

Fondazione IRCCS Instituto Neurologico Carlo Besta

Milan, , Italy

Site Status

Sacred Heart Catholic University

Rome, , Italy

Site Status

Universita e AO Citta delia Scienza, Universita Di Torino

Torino, , Italy

Site Status

Grupo Médico Camino S.C.

México, D.F, Mexico

Site Status

Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, Mexico

Site Status

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

Culiacán, Sinaloa, Mexico

Site Status

Servicios Medicos de Investigacion Clinica Sc

Durango, , Mexico

Site Status

Hospital Central "Ignacio Morones Prieto"

San Luis Potosí City, , Mexico

Site Status

Medisch Centrum Haaglanden

The Hague, South Holland, Netherlands

Site Status

VUMC

Amsterdam, , Netherlands

Site Status

Radboud University Nijmegen Medical Center

Nijmegen, , Netherlands

Site Status

Christchurch Hospital

Christchurch Central, Christchurch, New Zealand

Site Status

Palmerston North Hospital

Roslyn, Palmerston North, New Zealand

Site Status

Waikato Hospital, Regional Cancer Centre

Hamilton, Waikato District, New Zealand

Site Status

Waikato Hospital, Regional Cancer Center

Hamilton, Waikato Distric, New Zealand

Site Status

Hospital Almanzor Aguinaga Asenjo

Chiclayo, , Peru

Site Status

Instituto Oncologico Miraflores

Lima, , Peru

Site Status

Clinica Anglo Americana

Lima, , Peru

Site Status

Clinica Ricardo Palma

Lima, , Peru

Site Status

Oncosalud

Lima, , Peru

Site Status

Institut Catala d Oncologia

LaHospitalet de Lubregat, Catalonia, Spain

Site Status

Dra. Sonia Del Barco Berron, ICO Girona Avda,

Franca, Girona, Spain

Site Status

Hospital Clinic

Barcelona, , Spain

Site Status

ICO Badalona-Hospital Germans Trias i Pujol

Barcelonia, , Spain

Site Status

Hospital 12 de Octubre

Madrid, , Spain

Site Status

Kantonsspital Aarau Medizinische Onkologie Tellstrasse

Aarau, Canton of Aargau, Switzerland

Site Status

CHUV, Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Site Status

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, , Switzerland

Site Status

Inselspital, Universitatsspital Bern, Universitatsklinik fur Medizinische Onkologie, Freiburgstrasse

Bern, , Switzerland

Site Status

Hopitaux Universitaires de Geneve-HUG-Centre d'Oncologie

Geneva, , Switzerland

Site Status

Brain Tumor Center, University Hospital Zurich

Zurich, , Switzerland

Site Status

National Cheng Kung University Hospital

Tainan City, Bei District, Taiwan

Site Status

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Chang Gung Memorial Hospital Linkou Branch

Taichung, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

Chi Mei Medical Center

Tainan City - Yongkang District, , Taiwan

Site Status

Tri-Service General Hospital

Taipei City - Neihu District, , Taiwan

Site Status

Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status

King Chulalongkorn Memorial Hospital

Patumwan, Bankok, Thailand

Site Status

Songkhlanagarind Hospital

Hat Yai, Changwat Songkhla, Thailand

Site Status

Maharaj Nakorn Chiang Mai Hospital

Amphoe Muang, Chiang Mai, Thailand

Site Status

Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Site Status

The Bristol Haematology and Oncology Centre

Bristol, , United Kingdom

Site Status

Edinburgh Cancer Centre Western General Hospital

Edinburgh, , United Kingdom

Site Status

Beatson West of Scotland Cancer Centrel

Glasgow, , United Kingdom

Site Status

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

London, , United Kingdom

Site Status

Nottingham City Hospital

Nottingham, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Austria Belgium Brazil Canada Colombia Czechia France Germany Greece Hungary India Israel Italy Mexico Netherlands New Zealand Peru Spain Switzerland Taiwan Thailand United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 28844499 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36346112 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CDX110-04

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Surgical Pembro +/- Olaparib w TMZ for rGBM
NCT05463848 RECRUITING PHASE2