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1、 Journal of Clinical Oncology List of Issues Volume 38,Issue 15_suppl Meeting Abstract|2020 ASCO Annual Meeting IGASTROINTESTINAL CANCERGASTROESOPHAGEAL,PANCREATIC,ANDHEPATOBILIARYA multicenter randomized phase II study ofnivolumab in combination withgemcitabine/cisplatin or ipilimumab as first-Righ

2、ts&PermissionsOPTIONS&TOOLSExport CitationTrack CitationAdd To FavoritesADVERTISEMENTADADVERTISEMENTLog InSubmitE-AlertsCartOpenAthens/Shibboleth MENU Article Toolsline therapy for patients with advancedunresectable biliary tract cancer(BilT-01).Vaibhav Sahai,Kent A.Griffith,Muhammad Shaalan Beg,Wal

3、id Labib Shaib,Devalingam Mahalingam,David Bing Zhen,.Show MoreAbstract Disclosures4582Background:Patients(pts)with advanced biliarytract cancers(BTC)have poor prognosis with amedian overall survival(OS)less than 12 months(mos).This randomized phase 2,multi-institutional,study was designed to invest

4、igatethe role of combinational immunotherapy,usingnivolumab(nivo)with gemcitabine(gem)/cisplatin(cis),or nivo with ipilimumab(ipi)in pts withuntreated advanced BTC.Methods:Key eligibilitycriteria include histologically confirmedunresectable or metastatic BTC without priorCOMPANION ARTICLESNo compani

5、on articlesARTICLE CITATIONDOI:10.1200/JCO.2020.38.15_suppl.4582Journal of Clinical Oncology 38,no.15_suppl(May 20,2020)4582-4582.Published online May 25,2020.WE RECOMMENDADVERTISEMENTEmployer:Merritt HawkinsApply for this job Employer:Potomac Oncology&HematologyApply for this job Hematology-Oncolog

6、y OpportunityJust Outside of ChicagoRockford,Illinois N/AA reputable integrated health system seekinga board-certified or board-eligiblehematologist-oncologist to join its team.Oncology&Hematology AssociatePositionRockville,Maryland Competitive SalaryThis position offers a competitive base salary,a

7、comprehensive benefits package,exceptional productivity incentives,and apartnership track.Hematology/Oncology-at the Beach inLow Tax Delaware!Delaware(US);Family-oriented resort area inbeautiful south coastal DelawareAbstractNivolumab Plus Ipilimumab forTreatment-Nave Metastatic UvealMelanoma:An Ope

8、n-Label,Multicenter,Phase II Trial by theSpanish Multidisciplinary MelanomaGroup(GEM-1402)Jos Mara Piulats et al.,J Clin Oncol,2021Nivolumab Plus Ipilimumab inPatients With Advanced Melanoma:Updated Survival,Response,andSafety Data in a Phase I Dose-Escalation StudyMargaret K.Callahan et al.,J ClinO

9、ncol,2017Fixed dose-rate gemcitabine(GEM)infusion in advanced pancreaticsystemic therapy,measurable disease perRECISTv1.1,ECOG PS 0-1,and absence ofautoimmune disease or chronic steroid use.Arm Aincluded gem 1000 mg/m and cis 25 mg/m d1,8Q3w+nivo 360 mg d1 Q3w for 6 mos followed bynivo 240 mg Q2w mo

10、notherapy for a totalduration of 2 yrs;Arm B included nivo 240 mg Q2wand ipi 1 mg/kg Q6w for 2 yrs,in absence ofdisease progression.Primary endpoint isprogression-free survival(PFS)rate at 6 mos withan alternative hypothesis of 80%(null hypothesisof 59%,one-sided alpha 0.05,power 80%)for eachnon-com

11、parative arm.Secondary endpointsinclude overall response rate(ORR)per immunerelated(ir)RECIST,median PFS and OS and safety.Exploratory objectives include biomarker analysisusing include sequential wholeexome/transcriptome and immune cell subsets intissue and blood.Results:71 eligible pts(49%male,83%

12、Caucasian)with 35 in Arm and 36 inArm B with a median age of 62(range 20-80)yrs,and majority with metastatic disease(90%)wereenrolled across 6 US sites.PFS rate at 6 mos wasADVERTISEMENT22(PDAC)and biliary tree(BTC)carcinoma:A phase II studyA.Gelibter et al.,J Clin Oncol,20042018 Research Moves the

13、Field ofRCC ForwardDaniel M.Geynisman et al.,ASCODaily News,2019Nivolumab and Ipilimumab inMetastatic Uveal Melanoma:ResultsFrom a Single-Arm Phase II StudyMeredith S.Pelster et al.,J Clin Oncol,2020Survival outcomes and independentresponse assessment withnivolumab plus ipilimumab versussunitinib in

14、 patients with advancedrenal cell carcinoma:42-monthfollow-up of a randomized phase 3clinical trialRobert J Motzer et al.,Jitc,2020277 Safety and efficacy ofintratumoral ipilimumab with IVnivolumab in metastatic melanoma.The NIVIPIT trialLambros Tselikas et al.,JitcNivolumab plus ipilimumab versussu

15、nitinib for first-line treatment ofadvanced renal cell carcinoma:extended 4-year follow-up of thephase III CheckMate 214 trialLaurence Albiges et al.,ESMO open,2020New First-Line Treatment Leads toImproved Survival in GastrointestinalCancersBy staff,US Pharmacist,202070%in Arm A and 18.6%in Arm B.Th

16、e median PFSwas 8.8 mos(95%CI,6.1 to 11.3)in Arm A and 4.1mos(95%CI,2.4-5.2)in Arm B.Ten patients onArm A and 2 on Arm B remain on active treatment;additional 7 are in follow-up for OS.ORR,safetydata and median OS evaluation are underway andwill be presented at the meeting.Exploratoryanalyses are pe

17、nding.Conclusions:The observedPFS rates at 6 mos in either arm are insufficient toreject the null hypothesis of 59%PFS at 6 months.While Arm B is inferior,Arm A appears to be aseffective as standard of care although OSestimates are pending maturity.Clinical trialinformation:NCT03101566.2020 American

18、 Society of Clinical OncologyResearch Sponsor:Bristol-Myers SquibbUniversity of Michigan Rogel Cancer CenterNab-Paclitaxel and Gemcitabine asFirst-line Treatment of Advanced orMetastatic Cholangiocarcinoma:APhase 2 Clinical TrialVaibhav Sahai et al.,JAMA Oncology,2018Powered byQUICK LINKSContentReso

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