2018
CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer
Janjigian YY, Bendell J, Calvo E, Kim JW, Ascierto PA, Sharma P, Ott PA, Peltola K, Jaeger D, Evans J, de Braud F, Chau I, Harbison CT, Dorange C, Tschaika M, Le DT. CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer. Journal Of Clinical Oncology 2018, 36: 2836-2844. PMID: 30110194, PMCID: PMC6161834, DOI: 10.1200/jco.2017.76.6212.Peer-Reviewed Original ResearchConceptsObjective response rateGastroesophageal junction cancerEsophagogastric cancerJunction cancerOverall survivalTreatment-related grade 3/4 adverse eventsInvestigator-assessed objective response rateResponse rateGrade 3/4 adverse eventsProgression-free survival ratesEfficacy of nivolumabLong-term OSMeaningful antitumor activityMetastatic esophagogastric cancerMore prior therapiesNivolumab Plus IpilimumabSafety of nivolumabManageable safety profilePrimary end pointSecond-line chemotherapySuperior overall survivalPhase III studyAssociation of tumorPrior therapyData cutoff
2016
Safety and activity of nivolumab monotherapy in advanced and metastatic (A/M) gastric or gastroesophageal junction cancer (GC/GEC): Results from the CheckMate-032 study.
Le D, Bendell J, Calvo E, Kim J, Ascierto P, Sharma P, Ott P, Bono P, Jaeger D, Evans T, De Braud F, Chau I, Christensen O, Harbison C, Lin C, Janjigian Y. Safety and activity of nivolumab monotherapy in advanced and metastatic (A/M) gastric or gastroesophageal junction cancer (GC/GEC): Results from the CheckMate-032 study. Journal Of Clinical Oncology 2016, 34: 6-6. DOI: 10.1200/jco.2016.34.4_suppl.6.Peer-Reviewed Original ResearchObjective response rateNivolumab monotherapyOverall survivalPD-L1Negative tumorsPhase I/IIMedian overall survivalSingle-agent nivolumabTreatment-related deathsPD-L1 statusProgression-free survivalGastroesophageal junction cancerCell lung cancerFavorable safety profileRenal cell carcinomaAlkaline phosphatase levelsIgG4 monoclonal antibodyPrior regimensStable diseaseIntolerable toxicityMetastatic gastricPrimary endpointJunction cancerMedian durationObjective response