2022
Nivolumab plus radiotherapy with or without temozolomide in newly diagnosed glioblastoma: Results from exploratory phase I cohorts of CheckMate 143
Omuro A, Reardon DA, Sampson JH, Baehring J, Sahebjam S, Cloughesy TF, Chalamandaris AG, Potter V, Butowski N, Lim M. Nivolumab plus radiotherapy with or without temozolomide in newly diagnosed glioblastoma: Results from exploratory phase I cohorts of CheckMate 143. Neuro-Oncology Advances 2022, 4: vdac025. PMID: 35402913, PMCID: PMC8989388, DOI: 10.1093/noajnl/vdac025.Peer-Reviewed Original ResearchSafety/tolerabilityNew safety signalsOverall survivalCheckMate 143Median OSSafety signalsGrade 3/4 treatment-related adverse eventsTreatment-related adverse eventsEfficacy of nivolumabImmune checkpoint inhibitionMedian overall survivalPhase 1 cohortFirst-line treatmentPart APrimary endpointSecondary endpointsAdverse eventsCheckpoint inhibitionPatientsI cohortNivolumabTemozolomideRadiotherapyMonthsPart B
2017
Nivolumab with or without ipilimumab in patients with recurrent glioblastoma: results from exploratory phase I cohorts of CheckMate 143
Omuro A, Vlahovic G, Lim M, Sahebjam S, Baehring J, Cloughesy T, Voloschin A, Ramkissoon SH, Ligon KL, Latek R, Zwirtes R, Strauss L, Paliwal P, Harbison CT, Reardon DA, Sampson JH. Nivolumab with or without ipilimumab in patients with recurrent glioblastoma: results from exploratory phase I cohorts of CheckMate 143. Neuro-Oncology 2017, 20: 674-686. PMID: 29106665, PMCID: PMC5892140, DOI: 10.1093/neuonc/nox208.Peer-Reviewed Original ResearchConceptsAdverse eventsRecurrent glioblastomaCommon treatment-related adverse eventsTreatment-related adverse eventsDeath ligand 1 (PD-L1) expressionEffects of nivolumabExploratory efficacy outcomesSafety/tolerabilityFindings merit further investigationLigand 1 expressionCheckMate 143Ipilimumab doseNivolumab monotherapyStable diseaseAlternative regimenEfficacy outcomesRadiographic progressionMost patientsPartial responseNivolumabIpilimumabMerit further investigationPatientsI cohortFurther evaluationOS07.3 Nivolumab in Combination With Radiotherapy With or Without Temozolomide in Patients With Newly Diagnosed Glioblastoma: Updated Results From CheckMate 143
Omuro A, Vlahovic G, Baehring J, Butowski N, Reardon D, Cloughesy T, Sahebjam S, Lim M, Zwirtes R, Sampson J. OS07.3 Nivolumab in Combination With Radiotherapy With or Without Temozolomide in Patients With Newly Diagnosed Glioblastoma: Updated Results From CheckMate 143. Neuro-Oncology 2017, 19: iii13-iii13. PMCID: PMC5463686, DOI: 10.1093/neuonc/nox036.044.Peer-Reviewed Original ResearchTreatment-related AEsAdverse eventsCheckMate 143Standard radiotherapyDisease progressionFirst prospective clinical trialHerpes simplex virus encephalitisTreatment-related adverse eventsTolerability of nivolumabTreatment-related deathsImmune checkpoint inhibitorsSimplex virus encephalitisDeath-1 receptorNew safety signalsPhase 2/3 studyProspective clinical trialsImmune cell infiltrationNovel therapeutic optionsMonoclonal antibody inhibitorMultiple cancer typesConcurrent temozolomideUnmethylated MGMTAdjuvant temozolomideCheckpoint inhibitorsRadiographic progressionOS10.3 Randomized Phase 3 Study Evaluating the Efficacy and Safety of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: CheckMate 143
Reardon D, Omuro A, Brandes A, Rieger J, Wick A, Sepulveda J, Phuphanich S, de Souza P, Ahluwalia M, Lim M, Vlahovic G, Sampson J. OS10.3 Randomized Phase 3 Study Evaluating the Efficacy and Safety of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: CheckMate 143. Neuro-Oncology 2017, 19: iii21-iii21. PMCID: PMC5463583, DOI: 10.1093/neuonc/nox036.071.Peer-Reviewed Original ResearchObjective response rateTreatment-related AEsProgression-free survivalOverall survivalRecurrent glioblastomaSerious AEsMeasurable diseaseOS ratesInvestigator-assessed progression-free survivalCommon treatment-related AEsHuman IgG4 monoclonal antibodyOnly serious AESafety of nivolumabMedian overall survivalNeuro-Oncology criteriaSecond-line settingDeath-1 receptorSingle-agent therapyAvailable treatment optionsMalignant neoplasm progressionIgG4 monoclonal antibodyMultiple cancer typesCheckMate 143Evaluable ptsImproved OS
2016
ATIM-16. NIVOLUMAB COMBINED WITH RADIOTHERAPY WITH OR WITHOUT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA: RESULTS FROM PHASE 1 SAFETY COHORTS IN CHECKMATE 143
Omuro A, Vlahovic G, Baehring J, Butowski N, Reardon D, Cloughesy T, Sahebjam S, Lim M, Strauss L, Latek R, Zwirtes R, Paliwal P, Harbison C, Sampson J. ATIM-16. NIVOLUMAB COMBINED WITH RADIOTHERAPY WITH OR WITHOUT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA: RESULTS FROM PHASE 1 SAFETY COHORTS IN CHECKMATE 143. Neuro-Oncology 2016, 18: vi21-vi21. DOI: 10.1093/neuonc/now212.081.Peer-Reviewed Original ResearchAdverse eventsCheckMate 143Frequent treatment-related adverse eventsTreatment-related serious adverse eventsFirst prospective clinical trialProgression/unacceptable toxicityTreatment-related adverse eventsCombination of nivolumabTolerability of nivolumabSerious adverse eventsDeath-1 receptorProspective clinical trialsNew safety concernsMonoclonal antibody inhibitorMultiple cancer typesMeasurable diseaseNivolumab CombinedSafety cohortToxic deathsTumor flareRadiographic progressionTreatment discontinuationMost patientsUnacceptable toxicityPoor prognosisSafety and activity of nivolumab (nivo) monotherapy and nivo in combination with ipilimumab (ipi) in recurrent glioblastoma (GBM): Updated results from checkmate-143.
Reardon D, Sampson J, Sahebjam S, Lim M, Baehring J, Vlahovic G, Cloughesy T, Strauss L, Latek R, Paliwal P, Harbison C, Voloschin A, Omuro A. Safety and activity of nivolumab (nivo) monotherapy and nivo in combination with ipilimumab (ipi) in recurrent glioblastoma (GBM): Updated results from checkmate-143. Journal Of Clinical Oncology 2016, 34: 2014-2014. DOI: 10.1200/jco.2016.34.15_suppl.2014.Peer-Reviewed Original Research
2015
NIMG-17CENTRAL NEUROPATHOLOGY REVIEW TO ASSIST IN THE EVALUATION OF IMMUNE-RELATED TREATMENT CHANGES VERSUS DISEASE PROGRESSION IN CHECKMATE-143
Ramkissoon S, Sampson J, Vlahovic G, Sahebjam S, Omuro A, Baehring J, Latek R, Vandeloise E, Coric V, Cloughesy T, Lim M, Reardon D, Ligon K. NIMG-17CENTRAL NEUROPATHOLOGY REVIEW TO ASSIST IN THE EVALUATION OF IMMUNE-RELATED TREATMENT CHANGES VERSUS DISEASE PROGRESSION IN CHECKMATE-143. Neuro-Oncology 2015, 17: v156-v157. PMCID: PMC4639040, DOI: 10.1093/neuonc/nov225.17.Peer-Reviewed Original ResearchNIMG-16PSEUDOPROGRESSION AND IMMUNOTHERAPY IN GLIOBLASTOMA: A CASE SERIES FROM COHORT 1 OF CHECKMATE-143 (NCT02017717)
Sahebjam S, Omuro A, Baehring J, Sampson J, Vlahovic G, Voloschin A, Hayes W, Latek R, Coric V, Cloughesy T, Lim M, Reardon D. NIMG-16PSEUDOPROGRESSION AND IMMUNOTHERAPY IN GLIOBLASTOMA: A CASE SERIES FROM COHORT 1 OF CHECKMATE-143 (NCT02017717). Neuro-Oncology 2015, 17: v156-v156. PMCID: PMC4639039, DOI: 10.1093/neuonc/nov225.16.Peer-Reviewed Original ResearchQOL-07DESCRIPTION OF CLINICAL AND PATIENT REPORTED OUTCOMES ASSESSMENTS FROM A PHASE 3, MULTICENTER, RANDOMIZED TRIAL EVALUATING NIVOLUMAB MONOTHERAPY VERSUS BEVACIZUMAB IN RECURRENT GLIOBLASTOMA: CHECKMATE-143
Nayak L, Brandes A, Omuro A, Rieger J, Wick A, Phuphanich S, Sumrall A, Sahebjam S, Ahluwalia M, de Souza P, Sepulveda J, Maio M, Grauer O, Vlahovic G, Baehring J, Dastani H, Latek R, Coric V, Reardon D. QOL-07DESCRIPTION OF CLINICAL AND PATIENT REPORTED OUTCOMES ASSESSMENTS FROM A PHASE 3, MULTICENTER, RANDOMIZED TRIAL EVALUATING NIVOLUMAB MONOTHERAPY VERSUS BEVACIZUMAB IN RECURRENT GLIOBLASTOMA: CHECKMATE-143. Neuro-Oncology 2015, 17: v189-v189. PMCID: PMC4639164, DOI: 10.1093/neuonc/nov230.07.Peer-Reviewed Original ResearchCBM-06IMMUNE BIOMARKER RESULTS FROM A TRIAL OF NIVOLUMAB ± IPILIMUMAB IN PATIENTS WITH RECURRENT GLIOBLASTOMA: CHECKMATE-143
Lowther D, Weinhold K, Reap E, Vlahovic G, Omuro A, Sahebjam S, Baehring J, Voloschin A, Cloughesy T, Lim M, Coric V, Latek R, Simon J, Lerner B, Raddassi K, Hafler D, Sampson J. CBM-06IMMUNE BIOMARKER RESULTS FROM A TRIAL OF NIVOLUMAB ± IPILIMUMAB IN PATIENTS WITH RECURRENT GLIOBLASTOMA: CHECKMATE-143. Neuro-Oncology 2015, 17: v70-v70. PMCID: PMC4638710, DOI: 10.1093/neuonc/nov211.06.Peer-Reviewed Original ResearchPreliminary safety and activity of nivolumab and its combination with ipilimumab in recurrent glioblastoma (GBM): CHECKMATE-143.
Sampson J, Vlahovic G, Sahebjam S, Omuro A, Baehring J, Hafler D, Voloschin A, Paliwal P, Grosso J, Coric V, Cloughesy T, Lim M, Reardon D. Preliminary safety and activity of nivolumab and its combination with ipilimumab in recurrent glioblastoma (GBM): CHECKMATE-143. Journal Of Clinical Oncology 2015, 33: 3010-3010. DOI: 10.1200/jco.2015.33.15_suppl.3010.Peer-Reviewed Original Research