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
2015
Sensitivity of plasma BRAFmutant and NRASmutant cell‐free DNA assays to detect metastatic melanoma in patients with low RECIST scores and non‐RECIST disease progression
Chang GA, Tadepalli JS, Shao Y, Zhang Y, Weiss S, Robinson E, Spittle C, Furtado M, Shelton DN, Karlin-Neumann G, Pavlick A, Osman I, Polsky D. Sensitivity of plasma BRAFmutant and NRASmutant cell‐free DNA assays to detect metastatic melanoma in patients with low RECIST scores and non‐RECIST disease progression. Molecular Oncology 2015, 10: 157-165. PMID: 26440707, PMCID: PMC4695284, DOI: 10.1016/j.molonc.2015.09.005.Peer-Reviewed Original ResearchConceptsNew brain metastasesDisease progressionTreatment initiationBrain metastasesDisease activityCtDNA levelsMetastatic melanomaProgression eventsRECIST scoresUseful blood-based biomarkerImmune checkpoint blockadeDisease progression eventsBRAF inhibitor therapyBlood-based biomarkersCell-free DNA assaysCheckpoint blockadeMetastatic diseaseInhibitor therapyTreatment courseLDH levelsPatient managementUseful biomarkerPatientsDroplet digital PCR assaysProgression