2024
Molecular analysis of the HCRN GU16-260-Cohort A phase II study of first-line (1L) nivolumab (nivo) and salvage nivo + ipilimumab (ipi) in patients (pts) with advanced clear cell renal cell carcinoma (accRCC).
Zaemes J, Hugaboom M, Shah V, Haas N, McDermott D, Jegede O, Bilen M, Stein M, Sosman J, Alter R, Plimack E, Hurwitz M, Wu C, Einstein D, Hammers H, Signoretti S, West D, Denize T, Atkins M, Braun D. Molecular analysis of the HCRN GU16-260-Cohort A phase II study of first-line (1L) nivolumab (nivo) and salvage nivo + ipilimumab (ipi) in patients (pts) with advanced clear cell renal cell carcinoma (accRCC). Journal Of Clinical Oncology 2024, 42: 4546-4546. DOI: 10.1200/jco.2024.42.16_suppl.4546.Peer-Reviewed Original ResearchObjective response rateImmune checkpoint blockadeProgression-free survivalProgressive diseaseAnti-VEGFOverall survivalAssociated with higher progression-free survivalTumor samplesAdvanced clear cell renal cell carcinomaCombined immune checkpoint blockadeHigher progression-free survivalIncreased PFSImmune checkpoint blockade therapyShorter progression-free survivalClear cell renal cell carcinomaAnti-VEGF therapyCell renal cell carcinomaWeeks of therapyRenal cell carcinomaBiomarkers of efficacyFFPE tumor samplesNIVO monotherapyCheckpoint blockadeDecreased OSProspective trials
2023
Phase II study of nivolumab and salvage nivolumab/ipilimumab in treatment-naïve patients with advanced non-clear cell renal cell carcinoma (HCRN GU16-260-Cohort B)
Atkins M, Jegede O, Haas N, McDermott D, Bilen M, Stein M, Sosman J, Alter R, Plimack E, Ornstein M, Hurwitz M, Peace D, Signoretti S, Denize T, Cimadamore A, Wu C, Braun D, Einstein D, Catalano P, Hammers H. Phase II study of nivolumab and salvage nivolumab/ipilimumab in treatment-naïve patients with advanced non-clear cell renal cell carcinoma (HCRN GU16-260-Cohort B). Journal For ImmunoTherapy Of Cancer 2023, 11: e004780. PMID: 36948504, PMCID: PMC10040058, DOI: 10.1136/jitc-2022-004780.Peer-Reviewed Original ResearchConceptsNivolumab/ipilimumabObjective response rateNon-clear cell renal cell carcinomaTreatment-naïve patientsCell renal cell carcinomaProgressive diseaseRenal cell carcinomaNivolumab monotherapyStable diseaseCell carcinomaAdvanced non-clear cell renal cell carcinomaMedian progression-free survivalTreatment-related adverse eventsDeath ligand 1 (PD-L1) expressionLigand 1 expressionPhase II studyProgression-free survivalWeeks of treatmentSymptomatic disease progressionEligible patientsSalvage therapyB patientsII studySalvage treatmentSarcomatoid features
2021
Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients (pts) with advanced non-clear cell renal cell carcinoma (nccRCC) (HCRN GU16-260-Cohort B).
Atkins M, Jegede O, Haas N, McDermott D, Bilen M, Hawley J, Sosman J, Alter R, Plimack E, Ornstein M, Hurwitz M, Peace D, Signoretti S, Wu C, Catalano P, Hammers H. Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients (pts) with advanced non-clear cell renal cell carcinoma (nccRCC) (HCRN GU16-260-Cohort B). Journal Of Clinical Oncology 2021, 39: 4510-4510. DOI: 10.1200/jco.2021.39.15_suppl.4510.Peer-Reviewed Original ResearchProgressive diseaseStable diseaseGrade 3Advanced non-clear cell renal cell carcinomaGrade 3 treatment-related adverse eventsNon-clear cell renal cell carcinomaTreatment-related adverse eventsMedian age 63Symptomatic progressive diseasePD-L1 statusPhase II studyTreatment-naïve patientsCell renal cell carcinomaWk of treatmentRenal cell carcinomaClear cell RCCCorrelative studiesAdvanced nccRCCEligible ptsUnclassified histologyMedian PFSSalvage therapyII studySalvage treatmentSarcomatoid features
2020
Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients (pts) with advanced renal cell carcinoma (RCC) (HCRN GU16-260).
Atkins M, Jegede O, Haas N, McDermott D, Bilen M, Drake C, Sosman J, Alter R, Plimack E, Rini B, Hurwitz M, Peace D, Signoretti S, Wu C, Catalano P, Hammers H. Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients (pts) with advanced renal cell carcinoma (RCC) (HCRN GU16-260). Journal Of Clinical Oncology 2020, 38: 5006-5006. DOI: 10.1200/jco.2020.38.15_suppl.5006.Peer-Reviewed Original ResearchRenal cell carcinomaProgressive diseaseStable diseaseGrade 3Sarcomatoid histologyPoor-risk renal-cell carcinomaAdvanced renal cell carcinomaMedian age 65Symptomatic progressive diseaseTreatment-related AEsTreatment-naïve patientsPhase II studyWk of treatmentEligible ptsImDC groupIpilimumab combinationMedian DoRMedian PFSSalvage therapyRespiratory failureSalvage treatmentII studyClinical outcomesMetastatic lesionsCell carcinoma