2019
MORPHEUS: A phase Ib/II study platform evaluating the safety and clinical efficacy of cancer immunotherapy (CIT)–based combinations in gastrointestinal (GI) cancers.
Desai J, Kortmansky J, Segal N, Fakih M, Oh D, Kim K, Rahma O, Ko A, Chung H, Alsina M, Yeh K, Li S, Al-Sakaff N, Patel J, Barak H, Wang J, Zhang X, Bleul C, Cha E, Lee J. MORPHEUS: A phase Ib/II study platform evaluating the safety and clinical efficacy of cancer immunotherapy (CIT)–based combinations in gastrointestinal (GI) cancers. Journal Of Clinical Oncology 2019, 37: tps467-tps467. DOI: 10.1200/jco.2019.37.4_suppl.tps467.Peer-Reviewed Original ResearchPancreatic ductal adenocarcinomaII trialUnacceptable toxicityClinical benefitColorectal cancerSignificant survival benefitGastroesophageal junction cancerCancer immune responseImmune escape mechanismsMultiple tumor typesSingle control armPrimary endpointSecondary endpointsDurable responsesJunction cancerSurvival benefitTreatment armsClinical efficacyGastrointestinal cancerPT cohortCancer immunotherapyControl armDuctal adenocarcinomaImmune responseMinimal efficacy
2015
Final analysis of a phase II study of Yale-modified FOLFIRINOX (mFOLFIRINOX) in metastatic pancreatic cancer (MPC).
James E, Cong X, Yao X, Hahn C, Kaley K, Li J, Kortmansky J, Fischbach N, Cha C, Salem R, Stein S, Hochster H, Lacy J. Final analysis of a phase II study of Yale-modified FOLFIRINOX (mFOLFIRINOX) in metastatic pancreatic cancer (MPC). Journal Of Clinical Oncology 2015, 33: 395-395. DOI: 10.1200/jco.2015.33.3_suppl.395.Peer-Reviewed Original ResearchMetastatic pancreatic cancerResponse rateProphylactic pegfilgrastimEntire cohortPhase II open-label studyFinal analysisECOG PS 0ECOG PS 0/1Grade 3/4 toxicitiesOpen-label studyPhase II studyBolus 5FUPS 0/1Febrile neutropeniaLAPC patientsPeritoneal diseaseII studyPS 0Surgical resectionUnacceptable toxicityImproved tolerabilityPeripheral neuropathyMetastatic sitesPancreatic cancerFOLFIRINOX