2020
P858 An open-label, multi-center trial of INO-5401 and INO-9012 delivered by electroporation (EP) in combination with cemiplimab in subjects with newly-diagnosed glioblastoma (GBM)
Skolnik J, Reardon D, Brem S, Desai A, Bagley S, Kurz S, de la Fuente M, Nagpal S, Welch M, Sacchetta B, Bartra S, Bredlau A, Lowy I, Kraynyak K, Morrow M, McMullan T, Boyer J. P858 An open-label, multi-center trial of INO-5401 and INO-9012 delivered by electroporation (EP) in combination with cemiplimab in subjects with newly-diagnosed glioblastoma (GBM). Journal For ImmunoTherapy Of Cancer 2020, 8: a8. DOI: 10.1136/lba2019.12.Peer-Reviewed Original ResearchNewly-diagnosed GBMCheckpoint inhibitorsCheckpoint inhibitionOverall survivalCohort ASafety profileClinical efficacyPD-1 checkpoint inhibitorsImmune-related AECycles of temozolomideT cell responsesNewly-diagnosed glioblastomaWeeks of treatmentPreliminary clinical efficacyMulti-center trialInstitutional ethics boardMaintenance temozolomidePD-1Open-labelCohort B.Median agePhase I/IICohort BCemiplimabAdverse events
2018
ATIM-08. A PHASE I TRIAL OF PEMBROLIZUMAB AND VORINOSTAT COMBINED WITH TEMOZOLOMIDE AND RADIATION THERAPY FOR NEWLY DIAGNOSED GLIOBLASTOMA (NCT03426891)
Sahebjam S, Forsyth P, Tran N, Mokhtari S, Arrington J, Jaglal M, Etame A, Liu J, Wicklund M, Gatewood T, Macaulay R, Robinson T, Yu M. ATIM-08. A PHASE I TRIAL OF PEMBROLIZUMAB AND VORINOSTAT COMBINED WITH TEMOZOLOMIDE AND RADIATION THERAPY FOR NEWLY DIAGNOSED GLIOBLASTOMA (NCT03426891). Neuro-Oncology 2018, 20: vi2-vi2. PMCID: PMC6216125, DOI: 10.1093/neuonc/noy148.005.Peer-Reviewed Original ResearchAdverse eventsPD-1/PD-L1 antibodiesDay 1Sequential dose-escalation cohortsOngoing phase I trialDose level 2Dose-escalation cohortsCommon adverse eventsDose level 1Phase II doseMonth survival ratePD-L1 antibodiesPhase I trialDose-escalation designPrimary study objectiveTumor immune recognitionPre-clinical experimentsEligible ptsMaintenance temozolomideSafety cohortConcurrent radiotherapySecondary endpointsEscalation cohortsI trialEscalation design
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