NUTMEG: A randomized phase II study of nivolumab and temozolomide versus temozolomide alone in newly diagnosed older patients with glioblastoma
Sim H, Wachsmuth L, Barnes E, Yip S, Koh E, Hall M, Jennens R, Ashley D, Verhaak R, Heimberger A, Rosenthal M, Hovey E, Ellingson B, Tognela A, Gan H, Wheeler H, Back M, McDonald K, Long A, Cuff K, Begbie S, Gedye C, Mislang A, Le H, Johnson M, Kong B, Simes J, Lwin Z, Khasraw M. NUTMEG: A randomized phase II study of nivolumab and temozolomide versus temozolomide alone in newly diagnosed older patients with glioblastoma. Neuro-Oncology Advances 2023, 5: vdad124. PMID: 37841696, PMCID: PMC10576515, DOI: 10.1093/noajnl/vdad124.Peer-Reviewed Original ResearchExperimental armStandard armOverall survivalAdverse eventsGrade-3 immune-related adverse eventImmune-related adverse eventsUnexpected serious adverse eventsRandomized phase II studyRandomized phase II trialCombination of nivolumabMedian overall survivalPhase II studySerious adverse eventsNew safety signalsOS hazard ratioPhase II trialPhase III trialsAdjuvant nivolumabImmunologic rationaleII trialHazard ratioII studyIII trialsOlder patientsImmunotherapy trials[18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial
Koh E, Gan H, Senko C, Francis R, Ebert M, Lee S, Lau E, Khasraw M, Nowak A, Bailey D, Moffat B, Fitt G, Hicks R, Coffey R, Verhaak R, Walsh K, Barnes E, De Abreu Lourenco R, Rosenthal M, Adda L, Foroudi F, Lasocki A, Moore A, Thomas P, Roach P, Back M, Leonard R, Scott A. [18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial. BMJ Open 2023, 13: e071327. PMID: 37541751, PMCID: PMC10407346, DOI: 10.1136/bmjopen-2022-071327.Peer-Reviewed Original ResearchConceptsFET PETPositron emission tomographyPrimary central nervous system cancerTumor progressionCentral nervous system cancerL-tyrosine positron emission tomographyFET-PET imagingPhase II studyCo-primary outcomesProgression-free survivalMaximal safe resectionPost-chemotherapy treatmentNervous system cancersHealth economic impactHuman Research Ethics CommitteePatterns of failureTrue tumor progressionGood clinical practiceDeclaration of HelsinkiRadiological progressionConcurrent chemoradiationInitial surgeryPostoperative radiotherapyII studyOverall survival