AzTrials
AzTrials

GlioblastomaPhase 3ACT IVNCT01480479

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

A Phase 3 study testing Rindopepimut (CDX-110) with GM-CSF, Temozolomide and KLH in people with Glioblastoma and Small Cell Glioblastoma, run by Celldex Therapeutics at 223 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rindopepimut (CDX-110) with GM-CSF, Temozolomide and KLH
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
745 participants
Where
223 sitesin 24 countries
Study dates
Nov 2011to Nov 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

223 sites in 24 countries.

223 sites in 24 countries

United States88 sites

  • Lehigh Valley Physician Group-Hematology-Oncology Associates

    Allentown, Pennsylvania, 18103

  • Dent Neurosciences Research Institute

    Amherst, New York, 14226

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Atlanta Cancer Care

    Atlanta, Georgia, 30005

  • Winship Cancer Institute, Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Georgia Regents University

    Augusta, Georgia, 30912

  • Texas Oncology Midtwon

    Austin, Texas, 78705

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21231

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Center for Cancer and Blood Disorders, PC

    Bethesda, Maryland, 20817

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Dana-Farber Cancer Institute and Mass General Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Fletcher Allen Health Care

    Burlington, Vermont, 05405

  • Medical University of South Carolina - Department of Neuroscience

    Charleston, South Carolina, 29425

  • University of Virginia Healthcare System

    Charlottesville, Virginia, 22908

  • Northwestern University Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio, 45267

  • University Hospitals, Case Medical Center (Cleveland)

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ellis Fischel Cancer Center

    Columbia, Missouri, 65203

  • Ohio State University

    Columbus, Ohio, 43210

  • Baylor Research Institute

    Dallas, Texas, 75246

  • City of Hope Cancer Center

    Duarte, California, 91010

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

    Durham, North Carolina, 27710

  • New Jersey Neuroscience Institute, JFK Medical Center

    Edison, New Jersey, 08818

  • North Shore University Health System

    Evanston, Illinois, 60201

  • University of Florida

    Gainesville, Florida, 32611

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

    Great Neck, New York, 11021

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Kaiser Permanente Hawaii Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • The Methodist Neurological Institute

    Houston, Texas, 77030

  • University of Tennessee Medical Center - Knoxville

    Knoxville, Tennessee, 37920

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center

    Lansing, Michigan, 48912

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • University of Wisconsin Paul P Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • North Shore University Hospital

    Manhasset, New York, 11030-3186

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Mount Sinai Medical Center, Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute

    Minneapolis, Minnesota, 55407

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Yale University Medical Center

    New Haven, Connecticut, 06520

  • Columbia University Medical Center - The Neurologic Institute of New York

    New York, New York, 10032

  • Weill Cornell Medical College

    New York, New York, 10065

  • Christiana Care Health Services

    Newark, Delaware, 19713

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

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

    Phoenix, Arizona, 85013

  • West Penn. Allegheny Health System

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • Providence Portland Medical Center, Oncology & Hematology Care

    Portland, Oregon, 97213

  • Pacific Neurosurgical

    Portland, Oregon, 97227

  • Kaiser Permanente, Redwood City Medical Center

    Redwood City, California, 94063

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California, Davis

    Sacramento, California, 95817

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

    Saginaw, Michigan, 48604

  • University of Utah Department of Neurosurgery

    Salt Lake City, Utah, 84112

  • University of California, San Francisco

    San Francisco, California, 94143

  • Swedish Neuroscience Institute

    Seattle, Washington, 98122

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • LSU Health Sciences Center, Feist-Weiller Cancer Center

    Shreveport, Louisiana, 71103

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Stanford Cancer Institute, Stanford University

    Stanford, California, 94305

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • University of Arizona Health Network

    Tucson, Arizona, 85724

  • Covenant Clinic / Iowa Spine and Brain Institute

    Waterloo, Iowa, 50702

  • Brain and Spine Surgeons of New York

    White Plains, New York, 10604

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Australia14 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Monash Medical Centre

    Clayton, Victoria, 3199

  • Austin Health

    Heidelberg, Victoria, 3084

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Launceston General Hospital

    Launceston, Tasmania, 7250

  • Liverpool Hospital

    Liverpool, 2107

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 06008

  • Calvary North Adelaide Hospital

    North Adelaide, South Australia, 5006

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Epworth Healthcare

    Richmond, Victoria, 3121

  • Mater Adult Hospital, Mater Misericordiae Health Services Brisbane Limited

    South Brisbane, Queensland, 4101

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2605

  • The Crown Princess Mary Cancer Centre, Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Canada13 sites

  • Foothills Hospital Medical Centre

    Calgary, Alberta, T3J 5N6

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • London Regional Cancer Program, London Health Sciences Centre

    London, Ontario, N6A 4L6

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

    Montreal, Quebec, H2L 4M1

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4

  • Ottawa Hospital, Regional Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • CHUQ L'Hotel Dieu de Qujebec

    Québec, Quebec, G1R 2J6

  • CHUS Hôpital Fleurimont

    Shenbrooke, Quebec, J1H5N4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N3M5

  • British Columbia Cancer Agency, Vancouver Clinic

    Vancouver, British Columbia, V5Z 4E6

  • BC Cancer Agency - Vancouver Island Centre

    Victoria, British Columbia, V8X 4V6

  • University of Manitoba-Cancer Care Manitoba

    Winnipeg, Manitoba, R3E0V9

Other trials in Canada

India11 sites

  • Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute

    Andheri-West, Mumbai, 400 053

  • HCG - Bangalore Institute of Oncology, Bangalore

    Bengaluru, Karnataka, 560027

  • Dr. Rai Memorial Medical Centre, Chennai

    Chennai, Tamil Nadu, 600018

  • Marathwada Regional Cancer Centre and Research Institute - Government

    Chhatrapati Sambhajinagar, Maharashtra, 431001

  • HCG Shanti Mukand Hospital - Curie Cancer Centre, Delhi

    Delhi, 110092

  • Sahyadri Hospitals Limited

    Erandauame, Pune, 411004

  • Indraprastha Apollo Hospital, New Delhi

    Jasola Viha, New Delhi, 110076

  • Amrita Institute of Medical Sciences and Research Centre, Kochi

    Kochi, Kerala, 682 026

  • Tata Memorial Hospital , Mumbai

    Parel, Mumbai, 400012

  • Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram

    Thiruvananthapuram, Kerala, 695 011

  • City Cancer Centre, Vijayawada

    Vijayawada, Andhra Pradesh, 520002

Other trials in India

France9 sites

  • Institut de Cancerologie de I'Quest-Paul Papin

    Angers, 49933

  • Institute Bergonie

    Bordeaux, 33076

  • Centre Leon Berard de Lyon

    Lyon, 69373

  • ICM Val d'Aurel Montpellier

    Montpellier, 342298

  • Institut de Cancerologie de L'Quest-Center Rane Gauducheau

    Nantes, 44805

  • Service de Neurologie-GH

    Paris, 75013

  • Centre Eugene Marquis

    Rennes, 35042

  • Institut de Cancerologie de l'ouest-Center Rene Gauducheau

    Saint-Herblain, 44805

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Brazil8 sites

  • Centro de Pesquisas Clinicas da Fundação Dr Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Hospital Mae de Deus-Centro de Pesquisa em Oncologia Clinica

    Porto Alegre, Rio Grande do Sul, 90840-440

  • Instituto Nacional do Cancer (INCA)

    Rio de Janeiro, 20231-050

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

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

  • Instituto do Câncer do Estado de São Paulo - ICESP

    São Paulo, 01246-000

  • Real e Benemerita Associação Portuguesa de Beneficiência/ Hospital São José

    São Paulo, 01321-001

  • Hospital A C Camargo

    São Paulo, 01509-900

  • Hospital Albert Einstein

    São Paulo, 05652-900

Other trials in Brazil

Germany8 sites

  • Strahlenklinik Universitatsklinikum Erlangen

    Erlangen, D-91054

  • Dr. Senchkenbergisches Institut fur Neuroonkologie

    Frankfurt, D-60528

  • University Hospital Hamburg Kopf und Neurozentrum

    Hamburg, 20246

  • Universitaetsklinikum Heidelberg, Neurologische Klinik, IM Neuenheimer Feld 672

    Heidelberg, 69120

  • University Medical Centre

    Kiel, 24105

  • LMU Munich

    Munich, D-81377

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Klinik und Poliklinik fur Neurologie der Universitat Regensburg

    Regensburg, Bavaria, 93053

Other trials in Germany

Hungary6 sites

  • Országos Onkológiai Intézet Sugárterápiás Osztály

    Budapest, 1122

  • Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet

    Debrecen, 4032

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

    Miskolc, 3526

  • Pécsi Tudományegyetem Általános Orvostudományi Kar

    Pécs, 7624

  • Szegedi Tudományegyetem Onkoterápiás Klinika

    Szeged, 6720

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

    Szombathely, 9700

Other trials in Hungary

Switzerland6 sites

  • Kantonsspital Aarau Medizinische Onkologie Tellstrasse

    Aarau, Canton of Aargau, 5001

  • Oncology Institute of Southern Switzerland (IOSI)

    Bellinzona, 6500

  • Inselspital, Universitatsspital Bern, Universitatsklinik fur Medizinische Onkologie, Freiburgstrasse

    Bern, 3010

  • Hopitaux Universitaires de Geneve-HUG-Centre d'Oncologie

    Geneva, 1211

  • CHUV, Centre Hospitalier Universitaire Vaudois

    Lausanne, Canton of Vaud, 1011

  • Brain Tumor Center, University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

Taiwan6 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Chang Gung Memorial Hospital Linkou Branch

    Taichung, 40705

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, Bei District, 704

  • Chi Mei Medical Center

    Tainan City - Yongkang District, 710

  • Tri-Service General Hospital

    Taipei City - Neihu District, 00114

Other trials in Taiwan

United Kingdom6 sites

  • The Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • Edinburgh Cancer Centre Western General Hospital

    Edinburgh, EH4 2XU

  • Beatson West of Scotland Cancer Centrel

    Glasgow, G12 0NY

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

    London, SE17EH

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Czechia5 sites

  • Hospital Ceske Budejovice

    České Budějovice, 370 01

  • Umiversity Hospital (Fakultni Nemocnice)

    Prague, 150 06

  • Hospital Na Homolce

    Prague, 150 30

  • Multiscan s.r.o.

    Prague, 155-00

  • Masaryk´s Hospital Usti nad Labem

    Ústí nad Labem, 401-13

Other trials in Czechia

Israel5 sites

  • Soroka University M.C.

    Beersheba, 84101

  • Rambam Health Care Campus

    Haifa, 3109601

  • Hadassah Medical Center

    Jerusalem, 91120

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • SHEBA Medical Center

    Tel HaShomer, 52126

Other trials in Israel

Mexico5 sites

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

    Culiacán, Sinaloa, 80020

  • Servicios Medicos de Investigacion Clinica Sc

    Durango, 34000

  • Hospital Civil de Guadalajara "Fray Antonio Alcalde"

    Guadalajara, Jalisco, 34000

  • Grupo Médico Camino S.C.

    México, D.F, 03310

  • Hospital Central "Ignacio Morones Prieto"

    San Luis Potosí City, 78240

Other trials in Mexico

Peru5 sites

  • Hospital Almanzor Aguinaga Asenjo

    Chiclayo

  • Instituto Oncologico Miraflores

    Lima, Lima 18

  • Clinica Anglo Americana

    Lima, Lima 27

  • Clinica Ricardo Palma

    Lima, Lima 27

  • Oncosalud

    Lima, Lima 41

Other trials in Peru

Spain5 sites

  • Hospital Clinic

    Barcelona, 8036

  • ICO Badalona-Hospital Germans Trias i Pujol

    Barcelonia, 08916

  • Dra. Sonia Del Barco Berron, ICO Girona Avda,

    Franca, Girona, 17007

  • Institut Catala d Oncologia

    LaHospitalet de Lubregat, Catalonia, 08908

  • Hospital 12 de Octubre

    Madrid, 28041

Other trials in Spain

Italy4 sites

  • UO Oncologie Medica Dipartimento Oncologico

    Bologna, 40139

  • Fondazione IRCCS Instituto Neurologico Carlo Besta

    Milan, 20133

  • Sacred Heart Catholic University

    Rome, 00168

  • Universita e AO Citta delia Scienza, Universita Di Torino

    Torino, 10126

Other trials in Italy

New Zealand4 sites

  • Christchurch Hospital

    Christchurch Central, Christchurch, 8011

  • Waikato Hospital, Regional Cancer Centre

    Hamilton, Waikato District, 3240

  • Waikato Hospital, Regional Cancer Center

    Hamilton, Waikato Distric, 3240

  • Palmerston North Hospital

    Roslyn, Palmerston North, 4414

Other trials in New Zealand

Thailand4 sites

  • Maharaj Nakorn Chiang Mai Hospital

    Amphoe Muang, Chiang Mai, 50200

  • Siriraj Hospital

    Bangkoknoi, Bangkok, 10700

  • Songkhlanagarind Hospital

    Hat Yai, Changwat Songkhla, 90110

  • King Chulalongkorn Memorial Hospital

    Patumwan, Bankok, 10330

Other trials in Thailand

Belgium3 sites

  • ZNA Middelheim

    Antwerp, B-2020

  • Universitair Ziekenhuis Antwerpen

    Edegem, Antwerp, 2650

  • Ghent University Hospital

    Ghent, 9000

Other trials in Belgium

Netherlands3 sites

  • VUMC

    Amsterdam, 1081HV

  • Radboud University Nijmegen Medical Center

    Nijmegen, 6525 GA

  • Medisch Centrum Haaglanden

    The Hague, South Holland, 2512 VA

Other trials in Netherlands

Austria2 sites

  • Medical University Innsbruck, Dept of Neurology, Anichstrabe 35

    Innsbruck, 6020

  • Medizinische Universität Wien, Innere Medizin I, Onkologie

    Vienna, 1090

Other trials in Austria

Greece2 sites

  • NNA

    Athens, Attica, 11521

  • "HYGEIA" Hospital

    Marousi, District of Attica, 151 23

Other trials in Greece

Colombia1 site

  • Fundacion Santa Fe

    Bogotá, Bogota D.C., 000

Other trials in Colombia

About this study

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

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.

Read the 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.

Being tested
Rindopepimut (CDX-110) with GM-CSF, Temozolomide, KLH
Keywords
EGFRvIII, Glioblastoma, Small cell, Giant cell, Gliosarcoma, oligodendroglial, Brain Cancer, Brain Tumor, radiotherapy, chemoradiation, Tumor, temozolomide, EGFR variant III
Medical subject headings
Glioblastoma, Gliosarcoma, Brain Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rindopepimut (CDX-110) with GM-CSFDrug

    Also called CDX-110 with sargramostim (GM-CSF) (Leukine®)

    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.

  • TemozolomideDrug

    Also called Temodar, Temodal

    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.

  • KLHDrug

    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.

Study groups in NCT01480479
Study groupRoleWhat they receive
Rindopepimut/GM-CSF plus TemozolomideExperimentalNot described
Receives: Drug: Rindopepimut (CDX-110) with GM-CSF; Drug: Temozolomide
KLH plus TemozolomideActive comparatorNot described
Receives: Drug: Temozolomide; Drug: KLH

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During treatment and every three months from end of treatment through end of study or approximately up to 5 years.

Secondary outcomes (2)

  1. Progression-free survival

    Compare progression-free survival between the two treatment arms

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

  2. 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

    Measured: Until day 28 of follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
745 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01480479
Sponsor's protocol ID
CDX110-04
Acronym
ACT IV
Status last verified
Apr 2017
First submitted
21 Nov 2011
Last updated
16 Jan 2018
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 28844499

  • 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.

    PubMed 36346112

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rindopepimut (CDX-110) with GM-CSF, Temozolomide and KLH in people with Glioblastoma and Small Cell Glioblastoma, run by Celldex Therapeutics at 223 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 223 sites in United States, Australia, Canada, India, France and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: During treatment and every three months from end of treatment through end of study or approximately up to 5 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01480479, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.

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