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 featuresTreatment-free survival (TFS) outcomes from the phase II study of nivolumab and salvage nivolumab + ipilimumab in advanced clear cell renal cell carcinoma (aRCC) (HCRN GU16-260-Cohort A).
Atkins M, Jegede O, McDermott D, Haas N, Bilen M, Stein M, Sosman J, Plimack E, Alter R, Ornstein M, Hurwitz M, Peace D, Einstein D, Catalano P, Hammers H, Regan M. Treatment-free survival (TFS) outcomes from the phase II study of nivolumab and salvage nivolumab + ipilimumab in advanced clear cell renal cell carcinoma (aRCC) (HCRN GU16-260-Cohort A). Journal Of Clinical Oncology 2023, 41: 604-604. DOI: 10.1200/jco.2023.41.6_suppl.604.Peer-Reviewed Original ResearchAdvanced clear cell renal cell carcinomaTreatment-related adverse eventsGrade 3Clear cell renal cell carcinomaActive treatment approachCheckMate 067 trialCheckMate 214 trialFurther anticancer therapyNivolumab/ipilimumabProlonged disease controlPhase II studyCell renal cell carcinomaKaplan-Meier curvesRenal cell carcinomaNivolumab monotherapyStable diseaseEligible patientsProtocol therapyTherapy initiationII studyTherapy cessationAdverse eventsSurvival outcomesCell carcinomaMetastatic melanoma
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