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
420 Progression-free survival and biomarker correlates of response with BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: results from the PIVOT-02 study
Diab A, Tykodi S, Daniels G, Maio M, Curti B, Lewis K, Jang S, Kalinka E, Puzanov I, Spira A, Cho D, Guan S, Puente E, Hoch U, Currie S, Nguyen T, Lin W, Tagliaferri M, Zalevsky J, Sznol M, Hurwitz M. 420 Progression-free survival and biomarker correlates of response with BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: results from the PIVOT-02 study. Journal For ImmunoTherapy Of Cancer 2020, 8: a256-a256. DOI: 10.1136/jitc-2020-sitc2020.0420.Peer-Reviewed Original ResearchBaseline tumor biopsiesMetastatic melanomaUntreated patientsPD-L1Clinical activityTumor biopsiesFDA breakthrough therapy designationGene expression profilesObjective response ratePD-L1 statusPhase 3 trialProgression-free survivalStage IV melanomaHigher ORRBiomarkers of responseNon-invasive biomarkersUnmet need existsBreakthrough therapy designationInstitutional review boardMedian PFSPrimary endpointDurable responsesComplete responseMore patientsOS ratesPhase 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