Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT): A Bayesian Adaptive Platform Trial to Develop Precision Medicines for Patients With Glioblastoma.
Journal
JCO precision oncology
ISSN: 2473-4284
Titre abrégé: JCO Precis Oncol
Pays: United States
ID NLM: 101705370
Informations de publication
Date de publication:
2019
2019
Historique:
accepted:
05
11
2018
entrez:
11
9
2020
pubmed:
27
3
2019
medline:
27
3
2019
Statut:
epublish
Résumé
Adequately prioritizing the numerous therapies and biomarkers available in late-stage testing for patients with glioblastoma (GBM) requires an efficient clinical testing platform. We developed and implemented INSIGhT (Individualized Screening Trial of Innovative Glioblastoma Therapy) as a novel adaptive platform trial (APT) to develop precision medicine approaches in GBM. INSIGhT compares experimental arms with a common control of standard concurrent temozolomide and radiation therapy followed by adjuvant temozolomide. The primary end point is overall survival. Patients with newly diagnosed unmethylated GBM who are INSIGhT (NCT02977780) is an ongoing novel biomarker-based, Bayesian APT for patients with newly diagnosed unmethylated GBM. Our goal is to dramatically shorten trial execution timelines while increasing scientific power of results and biomarker discovery using adaptive randomization. We anticipate that trial execution efficiency will also be improved by using the APT format, which allows for the collaborative addition of new experimental arms while retaining the overall trial structure.
Identifiants
pubmed: 32914038
doi: 10.1200/PO.18.00071
pii: 1800071
pmc: PMC7448806
pii:
doi:
Types de publication
Journal Article
Langues
eng
Subventions
Organisme : NCI NIH HHS
ID : R01 CA188228
Pays : United States
Informations de copyright
© 2019 by American Society of Clinical Oncology.
Déclaration de conflit d'intérêts
The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/po/author-center.Brian M. AlexanderEmployment: Foundation Medicine Consulting or Advisory Role: BMS, Precision Health Economics, AbbVie, Schlesinger AssociatesIsabel C. Arrillaga-RomanyHonoraria: Merck Consulting or Advisory Role: Insys Therapeutics, Karus Therapeutics, AgiosEudocia Q. LeeHonoraria: Medlink, UpToDate Consulting or Advisory Role: Eli LillyMikael L. RinneEmployment: Novartis Institutes for BioMedical Research Consulting or Advisory Role: N-of-OneManmeet S. AhluwaliaStock and Other Ownership Interests: MimiVax Honoraria: Prime Oncology, Elsevier, Itamar Medical (I) Consulting or Advisory Role: Monteris Medical, AstraZeneca, Bristol-Myers Squibb, AbbVie, CBT Pharmaceuticals, Kadmon, VBI Vaccines Research Funding: Novartis, TRACON Pharma, Novocure, Spectrum Pharmaceuticals, Eli Lilly/ImClone, Boehringer Ingelheim, AstraZenecaHoward ColmanHonoraria: Merck Sharp & Dohme Consulting or Advisory Role: Genentech, Roche, Novocure, Omniox, Insys Therapeutics, AbbVie Research Funding: Newlink Genetics, Plexxikon, Kadmon, Orbus Therapeutics, Merck, DNAtrix, AbbVie, BeiGeneEvanthia GalanisConsulting or Advisory Role: Genentech/Roche (Inst), AbbVie (Inst), Oncorus Research Funding: Genentech/Roche (Inst), Merck (Inst)John de GrootEmployment: Helsinn Therapeutics (I), ZIOPHARM Oncology (I) Leadership: ZIOPHARM Oncology (I) Stock and Other Ownership Interests: Gilead Sciences, ZIOPHARM Oncology (I) Consulting or Advisory Role: Celldex, Deciphera, Vascular Biogenics, Foundation Medicine, Genentech/Roche, Omniox, Oxigene, AbbVie, Novogen, Kadmon, Merck, Five Prime Therapeutics, Insys Therapeutics, AstraZeneca, Boston Biomedical, GW Pharmaceuticals, CarThera Research Funding: Deciphera, Novartis, Eli Lilly, Sanofi, EMD Serono, Mundipharma Patents, Royalties, Other Intellectual Property: Sanofi, research support; AstraZeneca, research support; EMD Serono, research support; Eli Lilly, research support; Novartis, research support; Deciphera Pharmaceuticals, research supportJan DrappatzEmployment: Via Oncology Stock and Other Ownership Interests: Exelixis, Bristol-Myers Squibb Honoraria: UpToDate, Via Oncology Consulting or Advisory Role: Oncorus, Immunomix Patents, Royalties, Other Intellectual Property: UpToDateAndrew B. LassmanHonoraria: Prime Oncology, WebMD, American Society of Clinical Oncology, Italian Association for Cancer Research, Focus Forward Incentives, Research America, Gerson Lehrman Group, Guidepoint Global, Health Advisors Bureau/Medefield, RICCA Group, Medsurvey, Olson Research Group, SAI-Med Partners, Schlesinger Associates, Market Strategies International, MSI Survey, Defined Health, marketplusresearch.com, AbbVie Consulting or Advisory Role: BioClinica, AbbVie, Sapience Therapeutics, AstraZeneca, Novocure, Kadmon, Cortice, Celgene, Agios Research Funding: AbbVie (Inst), Novartis (Inst), Karyopharm Therapeutics (Inst), Genentech/Roche (Inst), Novocure (Inst), Aeterna Zentaris (Inst), Pfizer (Inst), Bayer HealthCare Pharmaceuticals/Onyx Pharmaceuticals (Inst), Agenus (Inst), GlaxoSmithKline (Inst), Stemline Therapeutics (Inst), Northwest Biotherapeutics (Inst), Plexxikon (Inst), Tocagen (Inst), Regeneron (Inst), VBL Therapeutics (Inst), e-Therapeutics (Inst), Bristol-Myers Squibb (Inst), ImmunoCellular Therapeutics (Inst), Merck (Inst), Amgen (Inst), Celldex (Inst), Millennium Pharmaceuticals (Inst), MedImmune (Inst), Boehringer Ingelheim (Inst), Kadmon (Inst), RTOG Foundation (Inst), Boston Biomedical (Inst), BeiGene (Inst), Diffusion Pharmaceuticals (Inst), Agios (Inst), Celgene (Inst), Vascular Biogenics (Inst), Angiochem (Inst), Northwest Biotherapeutics (Inst), Orbus (Inst), VBI Vaccines (Inst) Travel, Accommodations, Expenses: Karyopharm Therapeutics, Tocagen, Radiological Society of North America, AbbVie, Agios, Novocure, NRG Oncology Foundation, Celgene, Kadmon, Bristol-Myers Squibb Other Relationship: Law firms as medical expert in malpractice/disability casesL. Burt NaborsConsulting or Advisory Role: Bristol-Myers Squibb Speakers’ Bureau: Merck/Schering PloughSandro SantagataConsulting or Advisory Role: RareCyteDavid SchiffConsulting or Advisory Role: Orbus Therapeutics, Monteris Medical, Cavion (Inst) Research Funding: Bayer HealthCare Pharmaceuticals (Inst)Mary R. WelchResearch Funding: Boston Biomedical Travel, Accommodations, Expenses: Boston BiomedicalKeith L. LigonStock and Other Ownership Interests: Travera Consulting or Advisory Role: Midatech Research Funding: Plexxikon (Inst), Amgen (Inst), X4 Pharma (Inst), Tragara (Inst), Bristol-Myers Squibb (Inst) Patents, Royalties, Other Intellectual Property: Molecular diagnostics assay patentPatrick Y. WenConsulting or Advisory Role: AbbVie, Genentech/Roche, Agios, AstraZeneca, Karyopharm Therapeutics, Vivus, Monteris Medical, Aurora Biopharma, Vascular Biogenics, Kadmon, ZIOPHARM Oncology, GW Pharmaceuticals, Eli Lilly, Immunomic Therapeutics Speakers’ Bureau: Merck, Agios (Inst), AbbVie (Inst), Angiochem (Inst), Genentech/Roche (Inst), GlaxoSmithKline (Inst), AstraZeneca (Inst), ImmunoCellular Therapeutics (Inst), Karyopharm Therapeutics (Inst), Merck (Inst), Novartis (Inst), Oncoceutics (Inst), Sanofi (Inst), ARIAD Pharmaceuticals (Inst), Vascular Biogenics (Inst), Eli Lilly No other potential conflicts of interest were reported
Références
Clin Pharmacol Ther. 2017 Dec;102(6):934-941
pubmed: 28795401
J Clin Oncol. 2017 Feb 20;35(6):681-687
pubmed: 28045624
Clin Pharmacol Ther. 2009 Jul;86(1):97-100
pubmed: 19440188
Neuro Oncol. 2014 May;16(5):696-706
pubmed: 24335699
N Engl J Med. 2017 Jul 6;377(1):62-70
pubmed: 28679092
Lancet Oncol. 2009 May;10(5):459-66
pubmed: 19269895
Clin Cancer Res. 2015 Apr 1;21(7):1514-24
pubmed: 25680375
Clin Cancer Res. 2008 Jul 15;14(14):4368-71
pubmed: 18628449
Neuro Oncol. 2015 Aug;17(8):1106-13
pubmed: 25568226
N Engl J Med. 2014 Feb 20;370(8):699-708
pubmed: 24552317
Neuro Oncol. 2015 Nov;17(11):1425-7
pubmed: 26374690
Biometrics. 2017 Sep;73(3):905-915
pubmed: 28211944
Neuro Oncol. 2018 May 18;20(6):826-837
pubmed: 29165638
Nat Rev Clin Oncol. 2011 Nov 08;9(4):199-207
pubmed: 22064459
Contemp Clin Trials. 2017 Mar;54:48-59
pubmed: 28089763
Neuro Oncol. 2017 Jul 1;19(7):908-917
pubmed: 28339723
J Clin Oncol. 2012 Sep 10;30(26):3258-63
pubmed: 22649140
J Natl Cancer Inst. 2009 Dec 2;101(23):1642-9
pubmed: 19903805
Neuro Oncol. 2013 Aug;15(8):972-8
pubmed: 23857706
N Engl J Med. 2016 Jul 7;375(1):23-34
pubmed: 27406347
Neuro Oncol. 2017 Apr 1;19(4):469-474
pubmed: 28388713
J Natl Cancer Inst. 2015 Jul 03;107(7):
pubmed: 26142446
Neuro Oncol. 2015 Feb;17(2):180-8
pubmed: 25165194
Neuro Oncol. 2014 May;16(5):615-6
pubmed: 24733851
Biostatistics. 2018 Apr 1;19(2):199-215
pubmed: 29036330
J Clin Oncol. 2017 Jul 20;35(21):2402-2409
pubmed: 28640706
Stat Med. 2014 Jun 15;33(13):2206-21
pubmed: 24421053
Cancer Discov. 2011 Jun;1(1):44-53
pubmed: 22586319
Neuro Oncol. 2015 May;17(5):765-6
pubmed: 25846289
Clin Cancer Res. 2018 Feb 15;24(4):737-743
pubmed: 28814435
N Engl J Med. 2016 Jul 7;375(1):11-22
pubmed: 27406346
Nature. 2008 Oct 23;455(7216):1061-8
pubmed: 18772890
Neuro Oncol. 2018 May 18;20(6):723-725
pubmed: 29617844
JAMA. 2015 Apr 28;313(16):1619-20
pubmed: 25799162
Stat Med. 2016 Sep 30;35(22):3892-906
pubmed: 27112322
N Engl J Med. 2005 Mar 10;352(10):987-96
pubmed: 15758009
Neuro Oncol. 2015 Oct;17(10):1344-55
pubmed: 25754088
Stat Methods Med Res. 2018 Jan;27(1):65-78
pubmed: 26763586
Neuro Oncol. 2018 Jul 5;20(8):1034-1043
pubmed: 29518210
N Engl J Med. 2014 Feb 20;370(8):709-22
pubmed: 24552318
Stat Biosci. 2018 Aug;10(2):420-438
pubmed: 30559900
J Clin Oncol. 2017 Sep 20;35(27):3160-3168
pubmed: 28530853