Phase IB/II Randomized Study of FOLFIRINOX Plus Pegylated Recombinant Human Hyaluronidase Versus FOLFIRINOX Alone in Patients With Metastatic Pancreatic Adenocarcinoma: SWOG S1313
Ramanathan RK, McDonough SL, Philip PA, Hingorani SR, Lacy J, Kortmansky JS, Thumar J, Chiorean EG, Shields AF, Behl D, Mehan PT, Gaur R, Seery T, Guthrie KA, Hochster HS. Phase IB/II Randomized Study of FOLFIRINOX Plus Pegylated Recombinant Human Hyaluronidase Versus FOLFIRINOX Alone in Patients With Metastatic Pancreatic Adenocarcinoma: SWOG S1313. Journal Of Clinical Oncology 2019, 37: jco.18.01295. PMID: 30817250, PMCID: PMC6494359, DOI: 10.1200/jco.18.01295.Peer-Reviewed Original ResearchConceptsMetastatic pancreatic cancerMedian overall survivalCombination armOverall survivalHazard ratioControl armPhase II open-label studyTreatment-related grade 3Adequate organ functionPhase II dosageOpen-label studyPrimary end pointMetastatic pancreatic adenocarcinomaOS hazard ratioHA statusDose-finding studyInterim futility analysisRecombinant human hyaluronidaseEnoxaparin prophylaxisThromboembolic eventsPerformance statusProlong survivalRandomized studyFutility analysisGood PSMORPHEUS: 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