@article{b3ce9df40137482e8f13d2fcd54c38ff,
title = "Glioblastoma Clinical Trials: Current Landscape and Opportunities for Improvement",
abstract = "Therapeutic advances for glioblastoma have been minimal over the past 2 decades. In light of the multitude of recent phase III trials that have failed to meet their primary endpoints following promising preclinical and early-phase programs, a Society for Neuro-Oncology Think Tank was held in November 2020 to prioritize areas for improvement in the conduct of glioblastoma clinical trials. Here, we review the literature, identify challenges related to clinical trial eligibility criteria and trial design in glioblastoma, and provide recommendations from the Think Tank. In addition, we provide a data-driven context with which to frame this discussion by analyzing key study design features of adult glioblastoma clinical trials listed on ClinicalTrials.gov as “recruiting” or “not yet recruiting” as of February 2021.",
author = "Bagley, {Stephen J.} and Shawn Kothari and Rifaquat Rahman and Lee, {Eudocia Q.} and Dunn, {Gavin P.} and Evanthia Galanis and Chang, {Susan M.} and Nabors, {Louis Burt} and Ahluwalia, {Manmeet S.} and Roger Stupp and Mehta, {Minesh P.} and Reardon, {David A.} and Grossman, {Stuart A.} and Sulman, {Erik P.} and Sampson, {John H.} and Simon Khagi and Michael Weller and Cloughesy, {Timothy F.} and Wen, {Patrick Y.} and Mustafa Khasraw",
note = "Funding Information: work. M. Khasraw reports personal fees from Roche, grants from BMS and AbbVie during the conduct of the study; personal fees from Janssen, Jax lab, Ipsen, and Pfizer; and grants from Specialized Therapeutics outside the submitted work. No disclosures were reported by the other authors. Funding Information: S.J. Bagley reports grants and personal fees from Novocure, grants from Incyte, GlaxoSmithKline, and Eli Lilly, and personal fees from Bayer and Sumitomo Dainnipon outside the submitted work. E.Q. Lee reports other support from Wolters Kluwer (Up to Date, Inc.), MedLink, Inc., Medscape, and Continuum outside the submitted work. G.P. Dunn reports personal fees from ImmunoGenesis and Ziopharm Oncology outside the submitted work. E. Galanis reports personal fees from Gradalis, Inc., Kiyatec, Inc., and Karyopharm and grants from Servier Pharmaceuticals LLC (formerly Agios Pharmaceuticals Inc.), Celgene, MedImmune, Inc., and Tracon Pharmaceuticals outside the submitted work. S.M. Chang reports other support from Agiios outside the submitted work. L.B. Nabors reports personal fees from Karyopharm and Penn outside the submitted work; in addition, L.B. Nabors has a patent for International Patent Application No. PCT/US2021/028460 pending. M.S. Ahluwalia reports grants from AstraZeneca Incyte, Pharmacyclics, Merck, and Bristol Myers Squibb; grants and personal fees from Bayer, Novocure, and AbbVie; grants, personal fees, and other support from Mimivax; personal fees from Kiyatec, Varian Medical Systems, Insightec, GlaxoSmithKline, Xoft, Nuvation, Cellularity, SDP Oncology, Flatiron, VBI Vaccines, Apollomics, Prelude, Janssen, Forma Therapeutics, Tocagen, Karyopharm, and Viewray; personal fees and other support from Doctible, Cytodyn, and MedInnovate Advisors LLC outside the submitted work; and is a stock shareholder in Doctible, Mimivax, Cytodyn, MedInnovate Advisors LLC. R. Stupp reports nonfinancial support from CarThera, Celularity, CranioVation/Alpheus, Hemispherian, Insightec, GT Medical Technologies, Northwest Biotherapeutics, and TriAct outside the submitted work. M.P. Mehta reports personal fees from Karyopharm, Sapience, Zap, Mevion, Xoft, Tocagen, Oncoceutics, and Chimerix outside the submitted work and is an NRG Oncology Brain Tumor Committee Chair. D.A. Reardon reports personal fees from AbbVie, Advantagen, Agenus, Agios, Amgen, AnHeart Therapeutics, Bayer, Boston Biomedical, Boehringer Ingelheim, Bristol Myers Squibb, Celldex, Deciphera, Del Mar Pharma, DNATrix, Ellipses Pharma, EMD Serono, Genenta, Genentech/Roche, Hoffman-LaRoche, Ltd., Imvax, Inovio, Kintara, Kiyatec, Medicenna Biopharma, Inc., Merck, Merck KGaA, Monteris, Neuvogen, Novartis, Novocure, Oncorus, Oxigene, Regeneron, Stemline, Sumitono Dainippon Pharma, Pyramid Biosciences, Inc., Taiho Oncology, Inc., and Y-mabs Therapeutics and grants from Acerta Pharmaceuticals, Agenus, Bristol Myers Squibb, Celldex, EMD Serono, Enterome, Epitopoietic Research Corporation, Incyte, Inovio, Insightec, Novartis, Omniox, and Tragara outside the submitted work. E.P. Sulman reports grants, personal fees, and nonfinancial support from Novocure, Zai Lab, and Merck outside the submitted work. J.H. Sampson reports consulting and licensing fees from Celldex Therapeutics and Medicenna Therapeutics and is on the board of directors with equity interest at Annias Immunotherapeutics and holds equity in Istari Oncology, Neuronium, and Immunomic Therapeutics. M. Weller reports grants and personal fees from Apogenix, Merck (EMD), and Adastra, grants from Quercis, personal fees from BMS, Medac, Merck Sharp & Dohme, Nerviano, Novartis, Orbus, Philogen, and y-Mabs outside the submitted work. T.F. Cloughesy reports personal fees from Global Coalition for Adaptive Research, Gan & Lee, BrainStorm, Katmai, Sapience, Inovio, DNATrix, Tyme, SDP, Novartis, Roche, Kintara, Bayer, Merck, Boehringer Ingelheim, VBL, Amgen, Kiyatec, Odonate, QED, Medfield, Pascal Biosciences, Tocagen, Karyopharm, AbbVie, and VBI outside the submitted work; in addition, T.F. Cloughesy has a patent for 62/ 819,322 pending and licensed to Katmai Pharmaceuticals and a patent for 63/ 179,769 pending and licensed to Katmai Pharmaceuticals; and is a cofounder, major stock holder, consultant and board member of Katmai Pharmaceuticals, member of the board for the 501c3 Global Coalition for Adaptive Research, holds stock option in Notable Labs, holds stock in Chimerix and receives milestone payments and possible future royalties, and is a member of the scientific advisory board for Break Through Cancer and Cure Brain Cancer Foundation. P.Y. Wen reports personal fees and other support from Agios, AstraZeneca/Medimmune, Merck, Vascular Biogenics; other support from Beigene, Celgene, Eli Lily, Genentech/Roche, Kazia, and MediciNova; and personal fees from Bayer, Boston Pharmaceuticals, CNS Pharmaceuticals, Elevate Bio Immunomic Therapeutics, Imvax, Karyopharm, VBI Vaccines, Voyager, QED, Celularity, and Sapience; and receives other support from Novartis, Nuvation Bio, Oncoceutics, and Vascular Biogenics outside the submitted Publisher Copyright: {\textcopyright} 2021 American Association for Cancer Research",
year = "2022",
month = feb,
day = "15",
doi = "10.1158/1078-0432.CCR-21-2750",
language = "English (US)",
volume = "28",
pages = "594--602",
journal = "Clinical Cancer Research",
issn = "1078-0432",
publisher = "American Association for Cancer Research Inc.",
number = "4",
}
