A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)
Glioblastoma, Gliosarcoma
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring Newly Diagnosed Glioblastoma, Epithelial Growth Factor Receptor (EGFR), Temozolomide, ABT-414, Radiology Therapy Oncology Group, Antibody Drug Conjugate, Brain Tumor, Brain Tumor Group, EGFRvIII, EGFR Amplified, First Line Therapy, Brain Cancer
Eligibility Criteria
Inclusion Criteria:
- Must have a clinical diagnosis of Glioblastoma (GBM).
- Must have a confirmed Epidermal growth factor receptor amplification in tumor tissue.
- Must have a Karnofsky Performance Status (KPS) >= 70 at assessment <= 14 days prior to randomization (N/A to the sub-study).
- Must have recovered from effects of surgery, postoperative infection and other complications of surgery.
- Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the participant must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment).
Exclusion Criteria:
- Multifocal, recurrent or metastatic Glioblastoma (GBM) or gliomatosis cerebri (For the sub-study, the participant can have multifocal GBM and glimatosis cerebri but can't have recurrent or metastatic GBM).
- Prior chemo therapy or radiosensitizer for head and neck cancer.
- Prior radiotherapy to the head or neck in overlap of radiation fields.
- Prior therapy for glioblastoma or other invasive malignancy.
- Prior, concomitant or planned treatment with Novo Tumor Treatment Fields (Novo-TTF), EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.
Sites / Locations
- St. Josephs Hospital and Med Center /ID# 144149
- Highlands Oncology Group, PA /ID# 142050
- University of Southern California /ID# 147543
- University of California, Los Angeles /ID# 149239
- Sharp Memorial Hospital /ID# 148193
- Univ California, San Francisco /ID# 145889
- Duplicate_St. John's Health Center /ID# 148192
- Cedars-Sinai Medical Center-West Hollywood /ID# 148472
- Univ of Colorado Cancer Center /ID# 148194
- Associated Neurologists of Sou /ID# 147701
- Yale University /ID# 144170
- Christiana Care Health Service /ID# 144127
- Boca Raton Regional Hospital /ID# 163659
- Holy Cross Hospital /ID# 156764
- Baptist Hospital Miami /ID# 152451
- Advent Health /ID# 144128
- Moffitt Cancer Center /ID# 144130
- Piedmont Hospital /ID# 145892
- Emory Midtown Infectious Disease Clinic /ID# 144015
- Northwestern University Feinberg School of Medicine /ID# 147895
- The University of Chicago Medical Center /ID# 144158
- NorthShore University HealthSystem /ID# 144017
- Northwestern Medicine Cancer Center - Warrenville /ID# 148476
- Parkview Research Ctr, Hosp /ID# 144150
- Univ Kansas Cancer Ctr - Overl /ID# 145895
- Maine Medical Partners Neurolo /ID# 160864
- Tufts Medical Center /ID# 145897
- Massachusetts General Hospital /ID# 144145
- Dana-Farber Cancer Institute /ID# 148475
- Wayne State University /ID# 145890
- Henry Ford Health System /ID# 145896
- Duplicate_St. Joseph Mercy Hospital /ID# 144143
- Mmcorc /Id# 144146
- Washington University-School of Medicine /ID# 144174
- Nebraska Methodist Hospital /ID# 144140
- University of Nebraska Medical Center /ID# 145899
- MD Anderson Cancer Center at Cooper - Camden /ID# 145891
- Rutgers Cancer Institute of New Jersey /ID# 148190
- Columbia University Medical Center /ID# 144020
- University of Rochester Medical Center /ID# 144166
- Levine Cancer Ins, Carolina Me /ID# 144124
- University of Cincinnati /ID# 144164
- Duplicate_Univ Hosp Cleveland /ID# 144153
- Cleveland Clinic Main Campus /ID# 144023
- The Ohio State University /ID# 144016
- University of Toledo /ID# 156763
- Univ Oklahoma HSC /ID# 144161
- St. Luke's Hospital /ID# 148191
- Penn State University and Milton S. Hershey Medical Center /ID# 147525
- University of Pennsylvania /ID# 157623
- Thomas Jefferson University /ID# 144191
- Fox Chase Cancer Center /ID# 145893
- Allegheny General Hospital /ID# 144126
- University of Pennsylvania Medical Center - Shadyside /ID# 144159
- Medical University of South Carolina /ID# 144141
- Austin Cancer Centers /ID# 151061
- Baylor Sammons Cancer Center /ID# 155542
- The University of Texas Health Science Center at Houston /ID# 144013
- University of Texas MD Anderson Cancer Center /ID# 144018
- Duplicate_Scott and White Medical Center /ID# 160743
- Intermountain Medical Center /ID# 144142
- University of Utah /ID# 144160
- Inova Health System /ID# 152956
- Virginia Commonwealth University Medical Center Main Hospital /ID# 149014
- Virginia Mason Medical Center /ID# 144022
- University of Washington /ID# 144162
- Univ of Wisconsin Hosp/Clinics /ID# 144167
- Froedtert Memorial Lutheran Hospital /ID# 144139
- Sanatorio Parque /ID# 142825
- Duplicate_Instituto Med Alex Flem /ID# 142884
- Liverpool Hospital /ID# 144392
- Duplicate_The Prince of Wales Hospital /ID# 144882
- Royal North Shore Hospital /ID# 143870
- Calvary Mater Newcastle /ID# 143860
- Southern Medical Day Care Centre /ID# 143868
- Princess Alexandra Hospital /ID# 143857
- Royal Adelaide Hospital /ID# 143867
- Calvary North Adelaide Hospita /ID# 143866
- St Vincent's Hospital Melbourne /ID# 143858
- Duplicate_Austin Hospital /ID# 143859
- St John Of God Subiaco Hospital /ID# 143869
- Medizinische Universitaet Graz /ID# 141982
- Medizinische Universitaet Wien /ID# 141981
- Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 141984
- Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 141983
- UCL Saint-Luc /ID# 141648
- Grand Hopital de Charleroi /ID# 141645
- UZ Gent /ID# 141647
- Universitair Ziekenhuis Leuven /ID# 143872
- Duplicate_Centre Hospitalier Jolimont /ID# 143873
- CHU de Liege /ID# 162860
- Duplicate_UCL Mont Godinne /ID# 141644
- Liga Norte Riograndense Contra o Câncer /ID# 143878
- Hospital Sao Lucas da PUCRS /ID# 143879
- Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 143876
- Instituto do Câncer do Estado de São Paulo - ICESP /ID# 144031
- Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 143877
- Duplicate_Cancer Care Manitoba /ID# 149253
- QE II Health Sciences Centre /ID# 151600
- Juravinski Cancer Centre /ID# 152117
- Victoria Hospital /ID# 144184
- Ottawa Hospital Research Institute /ID# 150120
- Princess Margaret Cancer Centre /ID# 166277
- Duplicate_Hospital Maisonneuve-Rosemont /ID# 149315
- Duplicate_Jewish General Hospital /ID# 144029
- Royal Victoria Hospital / McGill University Health Centre /ID# 144187
- CHUM - Notre-Dame Hospital /ID# 144027
- CHU de Quebec-Universite Laval /ID# 144189
- CHUS - Hopital Fleurimont /ID# 149771
- Anhui Provincial Hospital /ID# 166320
- SanboBrain Hospital Capital Medical University /ID# 166422
- Peking Union Medical College Hospital /ID# 157430
- Sun Yat-Sen University Cancer Center /ID# 143919
- Tongji Hospital Tongji Medical College of HUST /ID# 163820
- Duplicate_Xiangya Hospital Central South University /ID# 166791
- The First Affiliated Hospital of Soochow University /ID# 165596
- Duplicate_Tangdu Hospital /ID# 143920
- Duplicate_Huashan Hospital of Fudan University /ID# 159999
- Duplicate_The Second Affiliated Hospital of ZUSM /ID# 165593
- Beijing Tian Tan Hospital, Capital Medical University /ID# 167160
- The First Affiliated Hospital of Fujian Medical University /ID# 159166
- Duplicate_Shengjing Hospital of China Medical University /ID# 167016
- Duplicate_Tianjin Med Univ General Hosp /ID# 143923
- Hospital Pablo Tobon Uribe /ID# 143780
- Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 147223
- Administradora del Country_S.A-Clinica Del Country /ID# 143881
- Oncologos del Occidente S.A /ID# 147713
- Centro Medico Imbanaco de Cali /ID# 143882
- Masarykuv onkologicky ustav /ID# 143884
- Duplicate_FN Hradec Kralove /ID# 143885
- Krajska nemocnice Liberec, a.s. /ID# 142024
- Duplicate_Univ Hosp Ostrava-Poruba /ID# 143883
- Fakultni Nemocnice v Motole /ID# 142023
- AP-HM - Hopital de la Timone /ID# 143911
- CHRU Lille - Hopital Claude Huriez /ID# 143915
- Hopital Avicenne - APHP /ID# 143910
- Duplicate_Gustave Roussy /ID# 143912
- Institut de Cancérologie de l'Ouest René Gauducheau /ID# 143914
- CHU Nice -Hopital Pasteur /ID# 143916
- Insititut de Cancerologie /ID# 143908
- Hopital Pitie Salpetriere /ID# 143917
- Universitaetsklinik Heidelberg /ID# 143927
- Universitaetsklinikum Tuebingen /ID# 143926
- Universitaetsklinikum Leipzig /ID# 143962
- Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH /ID# 143961
- Prince of Wales Hospital /ID# 143952
- Beaumont Hospital /ID# 142969
- The Chaim Sheba Medical Center /ID# 143960
- Tel Aviv Sourasky Medical Center /ID# 143956
- Rambam Health Care Campus /ID# 143959
- Gastroenterology Institute, Division of Medicine /ID# 143958
- Rabin Medical Center /ID# 143957
- Duplicate_Duplicate_AOU Citta della Salute Scienza /ID# 141801
- Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800
- Istituto Oncologico Veneto /ID# 143821
- Duplicate_Regina Elena National Cancer I /ID# 141795
- National Cancer Center /ID# 141845
- Duplicate_Yonsei University Health System, Severance hospital. /ID# 141846
- Seoul National University Hospital /ID# 143886
- Samsung Medical Center /ID# 143887
- The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 141844
- Centro Medico Zambrano Hellion /ID# 143845
- Vrije Universiteit Medisch Centrum /ID# 143889
- Haaglanden Medisch Centrum /ID# 141405
- Universitair Medisch Centrum Groningen /ID# 141408
- Maastricht Universitair Medisch Centrum /ID# 143585
- Universitair Medisch Centrum Utrecht /ID# 141406
- Duplicate_Canterbury District Health Boa /ID# 143861
- Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 143890
- CCA Braga - Hospital de Braga /ID# 141940
- Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 141939
- IPO Lisboa FG, EPE /ID# 141938
- Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 141941
- Centro Hospitalar Universitario de Sao Joao, EPE /ID# 142830
- Regional Clinical Hospital of Kaliningrad region /ID# 141702
- State budgetary healthcare institution Republican Clinical Oncology Dispensary /ID# 141706
- GEMC - European Medical Center /ID# 141703
- Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 141707
- National Medical Research Center for Neurosurgery n.a. N. N. Burdenko /ID# 141701
- Federal State Treatment and Rehabilitation center /ID# 141704
- Sverdlovsk Regional Oncology Dispensary /ID# 141700
- National University Hospital /ID# 143933
- National Cancer Ctr Singapore /ID# 143932
- University of Free State, Universitas Annex (National Hospital Grounds) /ID# 144064
- Netcare Unitas Hospital /ID# 152936
- The Oncology Centre /ID# 143950
- Netcare Oncology Intervent Ctr /ID# 143951
- Rondebosch Oncology Center /ID# 143949
- Cape Town Oncology Trials /ID# 143948
- Hospital Regional de Malaga /ID# 143902
- Hospital Clinic de Barcelona /ID# 143906
- Hospital Santa Creu i Sant Pau /ID# 143900
- Hospital Clinico Universitario San Carlos /ID# 143901
- Hospital Universitario 12 de Octubre /ID# 143930
- Hospital Universitario HM Sanchinarro /ID# 143496
- Hospital General Universitario de Valencia /ID# 143903
- Kantonsspital Aarau AG /ID# 141885
- Universitatsspital Zurich /ID# 141887
- Duplicate_EOC Ospedale Regionale di Bellinzona e Valli /ID# 143936
- Inselspital, Universitätsspital Bern /ID# 141886
- National Taiwan University Hospital /ID# 143940
- Taipei Veterans General Hosp /ID# 143955
- Linkou Chang Gung Memorial Hospital /ID# 143941
- Guys and St Thomas NHS Foundation Trust /ID# 142652
- University Hospitals Birmingham NHS Foundation Trust /ID# 154592
- Velindre University NHS Trust /ID# 141996
- Duplicate_NHS Tayside /ID# 141651
- NHS Lothian /ID# 141802
- Leeds Teaching Hospitals NHS Trust /ID# 141653
- University College London Hospitals NHS Foundation Trust /ID# 142658
- Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 141999
- Royal Marsden Hospital /ID# 142827
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Experimental
Depatuxizumab Mafodotin, Radiation and Temozolomide (TMZ)
Placebo, Radiation and TMZ
Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZ
Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Depatuxizumab mafodotin is given to participants with hepatic impairment on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.