2023
A Phase II Trial of the CD40 Agonist Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Disease Progression on Anti-PD-1
Weiss S, Sznol M, Shaheen M, Berciano-Guerrero M, Couselo E, Rodríguez-Abreu D, Boni V, Schuchter L, Gonzalez-Cao M, Arance A, Wei W, Ganti A, Hauke R, Berrocal A, Iannotti N, Hsu F, Kluger H. A Phase II Trial of the CD40 Agonist Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Disease Progression on Anti-PD-1. Clinical Cancer Research 2023, 30: 74-81. PMID: 37535056, PMCID: PMC10767304, DOI: 10.1158/1078-0432.ccr-23-0475.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsDisease ProgressionHumansMelanomaNivolumabConceptsObjective response ratePhase II trialAdverse eventsPartial responseDisease progressionII trialGrade 3 adverse eventsAnti PD-1CD40 agonist antibodyElevated liver functionTreatment-related SAEsCommon adverse eventsActivation of CD40Subset of patientsFavorable safety profileAntigen presenting cellsStable diseaseMedian durationAdvanced melanomaAdditional patientsLiver functionSafety profileMetastatic melanomaPreclinical dataPresenting cells
2020
Prognostic and Predictive Biomarkers in Oligometastatic Disease.
Barnum KJ, Weiss SA. Prognostic and Predictive Biomarkers in Oligometastatic Disease. The Cancer Journal 2020, 26: 100-107. PMID: 32205533, PMCID: PMC9208067, DOI: 10.1097/ppo.0000000000000438.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCirculating Tumor DNAClinical Decision-MakingDisease-Free SurvivalHumansMicroRNAsMutationNeoplasmsNeoplastic Cells, CirculatingPatient SelectionPrognosisProgression-Free SurvivalRadiofrequency AblationRadiosurgeryRisk AssessmentSurvival RateConceptsLocal therapyOligometastatic diseaseSystemic therapyPredictive biomarkersCurative-intent local therapyAdvanced disease stateCancer-related deathSurvival benefitPatient candidatesMetastatic lesionsPatient selectionPoor prognosisAblative treatmentClinical definitionTumor biologyTherapyOligometastasesDisease statesDiseasePatientsLocal interventionsBiomarkersPolymetastasesPrognosisLesions
2019
Seronegative autoimmune autonomic ganglionopathy from dual immune checkpoint inhibition in a patient with metastatic melanoma
Gao CA, Weber UM, Peixoto AJ, Weiss SA. Seronegative autoimmune autonomic ganglionopathy from dual immune checkpoint inhibition in a patient with metastatic melanoma. Journal For ImmunoTherapy Of Cancer 2019, 7: 262. PMID: 31623673, PMCID: PMC6796437, DOI: 10.1186/s40425-019-0748-0.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsAutoimmune Diseases of the Nervous SystemHumansIpilimumabLung NeoplasmsMaleMelanomaMiddle AgedNivolumabPrimary DysautonomiasRectal NeoplasmsConceptsAutoimmune autonomic ganglionopathyImmune checkpoint inhibitor therapyMetastatic melanomaCheckpoint inhibitorsDual immune checkpoint inhibitionSympathetic nervous system responsesBackgroundImmune checkpoint inhibitorsCardiovascular autonomic testingCheckpoint inhibitor therapyImmune checkpoint inhibitionNervous system responsesEndocrine workupHypotension refractoryAutonomic testingImmunomodulatory therapyAdverse eventsCase presentationAFluid resuscitationInhibitor therapyCheckpoint inhibitionClinical outcomesDisease progressionNew symptomsEndocrine toxicityNivolumabPatterns of failure after immunotherapy with checkpoint inhibitors predict durable progression-free survival after local therapy for metastatic melanoma
Klemen ND, Wang M, Feingold PL, Cooper K, Pavri SN, Han D, Detterbeck FC, Boffa DJ, Khan SA, Olino K, Clune J, Ariyan S, Salem RR, Weiss SA, Kluger HM, Sznol M, Cha C. Patterns of failure after immunotherapy with checkpoint inhibitors predict durable progression-free survival after local therapy for metastatic melanoma. Journal For ImmunoTherapy Of Cancer 2019, 7: 196. PMID: 31340861, PMCID: PMC6657062, DOI: 10.1186/s40425-019-0672-3.Peer-Reviewed Original ResearchConceptsThree-year progression-free survivalProgression-free survivalDisease-specific survivalFive-year disease-specific survivalPatterns of failureDurable progression-free survivalLocal therapyStereotactic body radiotherapyMetastatic melanomaNew metastasesPatient selectionIndependent radiological reviewOngoing complete responseResultsFour hundred twentyEvidence of diseaseCNS metastasisCPI treatmentImmunotherapy failureCheckpoint inhibitorsMost patientsProgressive diseaseRadiological reviewComplete responsePD-1PD-L1