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
2017
Nivolumab combined with hypofractionated stereotactic irradiation (HFSRT) for patients with recurrent high grade gliomas: A phase I trial (NCT02829931).
Sahebjam S, Forsyth P, Arrington J, Tran N, Jaglal M, Mokhtari S, Long W, Macaulay R, Wicklund M, Drury-Sibiga A, Gatewood T, Robinson T, Raval R, Yu M. Nivolumab combined with hypofractionated stereotactic irradiation (HFSRT) for patients with recurrent high grade gliomas: A phase I trial (NCT02829931). Journal Of Clinical Oncology 2017, 35: tps2084-tps2084. DOI: 10.1200/jco.2017.35.15_suppl.tps2084.Peer-Reviewed Original ResearchHigh-grade gliomasPhase I trialGrade gliomasI trialPD-1PD-L1Grade IIIAnti-PD-1/PD-L1 blockadePD-1/PD-L1 blockadeRecurrent high-grade gliomaOngoing phase I trialDose-expansion cohortsPD-L1 blockadePrior radiation therapyTolerability of nivolumabGroup of patientsImmune checkpoint pathwaysLimited treatment optionsPreliminary antitumor activityOrthotopic murine modelLong-term survivalPrimary study objectiveIgG4 monoclonal antibodyNivolumab monotherapySafety cohort