2021
A phase 1b study of nivolumab in patients with autoimmune disorders and advanced malignancies (AIM-NIVO).
Dumbrava E, Dougan M, Gupta S, Cappelli L, Katsumoto T, Rahma O, Painter J, Wang Y, Suarez-Almazor M, Reid P, Wesley S, Hafler D, Bingham C, Warner B, Chung L, Ott P, Kluger H, Khosroshahi A, Tawbi H, Sharon E. A phase 1b study of nivolumab in patients with autoimmune disorders and advanced malignancies (AIM-NIVO). Journal Of Clinical Oncology 2021, 39: tps2676-tps2676. DOI: 10.1200/jco.2021.39.15_suppl.tps2676.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsDisease-specific cohortsAutoimmune disordersAdverse eventsAdvanced malignanciesAnti-PD-1/PD-L1 antibodiesPre-existing autoimmune disordersAnti-PD1 monoclonal antibodiesImpact of nivolumabPhase 1b studyKey secondary endpointPhase Ib studySerious adverse eventsDose-limiting toxicityInflammatory bowel diseasePD-L1 antibodiesSeverity IndexSystemic lupus erythematosusDysfunctional immune systemClinical Trials NetworkTissue-based biomarkersSpecific eligibility criteriaICI therapyPrimary endpointSecondary endpoints
2020
A phase Ib study of nivolumab in patients with autoimmune disorders and advanced malignancies (AIM-NIVO).
Ileana Dumbrava E, Suarez-Almazor M, Painter J, Johanns T, Dougan M, Cappelli L, Bingham C, Wang Y, Gupta S, Warner B, Rahma O, Naidoo J, Ott P, Hafler D, Kluger H, Khosroshahi A, Katsumoto T, Kummar S, Sharon E, Tawbi H. A phase Ib study of nivolumab in patients with autoimmune disorders and advanced malignancies (AIM-NIVO). Journal Of Clinical Oncology 2020, 38: tps3158-tps3158. DOI: 10.1200/jco.2020.38.15_suppl.tps3158.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsAnti-PD-1/PD-L1 antibodiesPhase Ib studyPD-L1 antibodiesAutoimmune disordersAdvanced malignanciesDisease-specific cohortsAdverse eventsIb studyPre-existing autoimmune disordersImpact of nivolumabRisk of flareKey secondary endpointSerious adverse eventsBest objective responseDose-limiting toxicityInflammatory bowel diseaseSeverity IndexSystemic lupus erythematosusAnti-PD1 antibodyClinical Trials NetworkTissue-based biomarkersSpecific eligibility criteriaICI therapyCheckpoint inhibitorsPembrolizumab for management of patients with NSCLC and brain metastases: long-term results and biomarker analysis from a non-randomised, open-label, phase 2 trial
Goldberg SB, Schalper KA, Gettinger SN, Mahajan A, Herbst RS, Chiang AC, Lilenbaum R, Wilson FH, Omay SB, Yu JB, Jilaveanu L, Tran T, Pavlik K, Rowen E, Gerrish H, Komlo A, Gupta R, Wyatt H, Ribeiro M, Kluger Y, Zhou G, Wei W, Chiang VL, Kluger HM. Pembrolizumab for management of patients with NSCLC and brain metastases: long-term results and biomarker analysis from a non-randomised, open-label, phase 2 trial. The Lancet Oncology 2020, 21: 655-663. PMID: 32251621, PMCID: PMC7380514, DOI: 10.1016/s1470-2045(20)30111-x.Peer-Reviewed Original ResearchConceptsBrain metastasis responseYale Cancer CenterPD-L1 expressionPhase 2 trialUntreated brain metastasesBrain metastasesAdrenal insufficiencyAdverse eventsMetastasis responseCNS diseaseCancer CenterCohort 2Cohort 1Eastern Cooperative Oncology Group performance statusTreatment-related serious adverse eventsModified Response Evaluation CriteriaStage IV NSCLCTreatment-related deathsAcute kidney injuryPD-1 blockadeSerious adverse eventsSolid Tumors criteriaPhase 2 studyProportion of patientsResponse Evaluation Criteria