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
Elective Colectomy in a Patient with Active Ulcerative Colitis and Metastatic Melanoma Enabling Successful Treatment with Immune Checkpoint Inhibitors.
Perdigoto AL, Tran T, Patel N, Clark P, Patell K, Stamatouli AM, Reddy V, Clune J, Herold KC, Robert ME, Kluger HM. Elective Colectomy in a Patient with Active Ulcerative Colitis and Metastatic Melanoma Enabling Successful Treatment with Immune Checkpoint Inhibitors. Clinical Oncology Case Reports 2020, 3 PMID: 33778814, PMCID: PMC7993656.Peer-Reviewed Original ResearchCheckpoint inhibitor therapyElective colectomyUlcerative colitisInhibitor therapyMetastatic melanomaImmune-related adverse eventsExcellent tumor responseImmune checkpoint inhibitorsSevere ulcerative colitisActive ulcerative colitisCheckpoint inhibitor immunotherapyCheckpoint inhibitor treatmentInflammatory bowel diseaseEffective treatment optionBenefits of treatmentImmune system activationTumor cell destructionCheckpoint inhibitorsAdvanced malignanciesAdverse eventsSelect patientsBowel diseaseAutoimmune diseasesTreatment optionsTumor responseA 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 inhibitors