2022
FRACTION-RCC: nivolumab plus ipilimumab for advanced renal cell carcinoma after progression on immuno-oncology therapy
Choueiri T, Kluger H, George S, Tykodi S, Kuzel T, Perets R, Nair S, Procopio G, Carducci M, Castonguay V, Folefac E, Lee C, Hotte S, Miller W, Saggi S, Lee C, Desilva H, Bhagavatheeswaran P, Motzer R, Escudier B. FRACTION-RCC: nivolumab plus ipilimumab for advanced renal cell carcinoma after progression on immuno-oncology therapy. Journal For ImmunoTherapy Of Cancer 2022, 10: e005780. PMID: 36328377, PMCID: PMC9639138, DOI: 10.1136/jitc-2022-005780.Peer-Reviewed Original ResearchConceptsAdvanced renal cell carcinomaObjective response rateDuration of responseIO therapyImmuno-oncology therapiesRenal cell carcinomaOverall survivalCell carcinomaAnti-PD-1/PD-L1 therapyImmune-mediated adverse eventsMedian DORProgression-free survival ratesTreatment-related deathsManageable safety profileMedian overall survivalPD-L1 therapyDurable clinical benefitKarnofsky performance statusPrimary outcome measureHigh unmet needExploratory endpointsIpilimumab armPFS ratesStable diseaseAdverse events
2019
Long-term follow-up of CA209-004: A phase I dose-escalation study of combined nivolumab (NIVO) and ipilimumab (IPI) in patients with advanced melanoma.
Atkins M, Kirkwood J, Wolchok J, Callahan M, Kluger H, Postow M, Segal N, Lesokhin A, Balogh A, Re S, Sznol M. Long-term follow-up of CA209-004: A phase I dose-escalation study of combined nivolumab (NIVO) and ipilimumab (IPI) in patients with advanced melanoma. Journal Of Clinical Oncology 2019, 37: 9533-9533. DOI: 10.1200/jco.2019.37.15_suppl.9533.Peer-Reviewed Original ResearchPhase I dose-escalation studyI dose-escalation studyDose-escalation studyOS ratesAdvanced melanomaIPI 3Survival rateUnresectable stage IIIECOG performance statusDiscontinuation of treatmentFavorable survival outcomesProgression-free survivalOverall survival rateLong-term survivalExploratory endpointsElevated LDHLast dosePrimary endpointSecondary endpointsStudy drugConcurrent therapyPerformance statusSurvival outcomesDisease progressionCohort 1