2020
CTIM-28. PHASE 2 TRIAL OF CONTROLLED IL-12 IN COMBINATION WITH PD-1 INHIBITOR IN ADULT SUBJECTS WITH RECURRENT GLIOBLASTOMA (rGBM)
Lukas R, Chiocca E, Bush N, Landolfi J, Cavaliere R, Yu J, Kurz S, Demars N, Buck J, Hadar N, Miao J, Loewy J, Wang Y, Gelb A, Cooper L. CTIM-28. PHASE 2 TRIAL OF CONTROLLED IL-12 IN COMBINATION WITH PD-1 INHIBITOR IN ADULT SUBJECTS WITH RECURRENT GLIOBLASTOMA (rGBM). Neuro-Oncology 2020, 22: ii39-ii39. PMCID: PMC7650356, DOI: 10.1093/neuonc/noaa215.162.Peer-Reviewed Original ResearchPD-1 inhibitorsImmune-mediated anti-tumor effectsAnti-tumor effectsRecurrent glioblastomaIL-12PD-1Overall survivalFollow-upIncreased PD-1 expressionIL-12 therapyPD-1 expressionPhase 2 trialPhase 1 trialPost-treatment biopsiesGene therapy candidateSurvival dataEndogenous cytokine productionIFN-g levelsTumor cell heterogeneityFunctional IL-12Blood-brain barrierCombination immunotherapyIT injectionSafety profileIFN-gSurvival of subjects with recurrent glioblastoma receiving intratumoral administration of controlled IL-12 with limited exposure to dexamethasone.
Lukas R, Kurz S, Yu J, Landolfi J, Rao G, Amidei C, Buck J, Hadar N, Estupinan T, Miao J, Loewy J, Wang Y, Demars N, Gelb A, Cooper L. Survival of subjects with recurrent glioblastoma receiving intratumoral administration of controlled IL-12 with limited exposure to dexamethasone. Journal Of Clinical Oncology 2020, 38: 2564-2564. DOI: 10.1200/jco.2020.38.15_suppl.2564.Peer-Reviewed Original ResearchMedian overall survivalImpact of DexIL-12Intratumoral administrationIFN-gGrade III or IV gliomaImmune-mediated anti-tumor effectsLow-dose corticosteroidsAnti-tumor responsesSerum IL-12Time of resectionTumor response dataRecombinant IL-12Survival of subjectsAnti-tumor effectsExposure to dexamethasoneImmune system activationOverall survivalRecurrent glioblastomaIV gliomasControl edemaPreclinical modelsSafety profileInterleukin-12Historical controls
2019
ATIM-18. SURVIVAL OF SUBJECTS WITH RECURRENT GLIOBLASTOMA RECEIVING INTRA-TUMORAL ADMINISTRATION OF IL-12 MANAGED WITH LOW-DOSE DEXAMETHASONE
Lukas R, Chiocca E, Kurz S, Yu J, Landolfi J, Rao G, Buck J, Demars N, Smith A, Miao J, Zhou J, Wang Y, Gelb A, Cooper L. ATIM-18. SURVIVAL OF SUBJECTS WITH RECURRENT GLIOBLASTOMA RECEIVING INTRA-TUMORAL ADMINISTRATION OF IL-12 MANAGED WITH LOW-DOSE DEXAMETHASONE. Neuro-Oncology 2019, 21: vi5-vi5. PMCID: PMC6847372, DOI: 10.1093/neuonc/noz175.018.Peer-Reviewed Original ResearchLow-dose dexamethasoneIL-12IFN-gIntratumoral injection of AdOngoing phase 1Low-dose corticosteroidsIntra-tumoral administrationProduction of IL-12Drug-related toxicityInjection of AdRecombinant IL-12Induce IL-12Overall survivalIntratumoral injectionDose-relatedDrug-related deathsGene therapyHistorical controlsAnticipated survivalSubject characteristicsSurvival dataSurvivalBiomarker studiesBiomarker analysisBiomarkersEvaluation of controlled IL-12 as monotherapy in subjects with recurrent GBM.
Lukas R, Chiocca E, Kurz S, Yu J, Landolfi J, Rao G, Barrett J, Buck J, Demars N, Smith A, Miao J, Zhou Q, Gelb A, Cooper L. Evaluation of controlled IL-12 as monotherapy in subjects with recurrent GBM. Journal Of Clinical Oncology 2019, 37: 2053-2053. DOI: 10.1200/jco.2019.37.15_suppl.2053.Peer-Reviewed Original ResearchCytokine release syndromeT cell ratioRecurrent glioblastomaIL-12Low-dose DexOverall survivalImmune-mediated anti-tumor effectsIntratumoral injection of AdImmune systemAnti-tumor responsesImproved overall survivalResponse to immunotherapySerum IL-12Replication-incompetent adenovirusCytotoxic T cellsInjection of AdAnti-tumor effectsDay 0Impact of DexFlu-like symptomsIL-12 productionInduce IL-12Biomarkers of OSRecurrent GBMIntratumoral injection