2024
Interim results of the randomized phase 2 cohort of study FW-2020-01 assessing the efficacy, safety and pharmacodynamics of CM24 in combination with nivolumab and chemotherapy in advanced/metastatic pancreatic cancer.
Macarulla T, Cecchini M, Garcia-Carbonero R, Golan T, Perets R, Borazanci E, Pedregal M, Ponz-Sarvise M, Al Hallak M, Pant S, Boni V, Saavedra O, de Miguel M, Leal A, Muñoz Martín A, Sauri T, Schickler M. Interim results of the randomized phase 2 cohort of study FW-2020-01 assessing the efficacy, safety and pharmacodynamics of CM24 in combination with nivolumab and chemotherapy in advanced/metastatic pancreatic cancer. Journal Of Clinical Oncology 2024, 42: lba4143-lba4143. DOI: 10.1200/jco.2024.42.17_suppl.lba4143.Peer-Reviewed Original ResearchDisease control rateProgression free survivalPancreatic ductal adenocarcinomaCarcinoembryonic antigen cell adhesion molecule 1Nal-IRIGemcitabine/nab-paclitaxelOverall survivalData cut-off dateRandomized phase 2 studyMedian follow-up timeCut-off dateAdequate organ functionAdvanced/metastatic pancreatic cancerPhase 2 studyLog-rank testFollow-up timeCell adhesion molecule 1Adhesion molecule 1Liposomal irinotecanFree survivalLine therapyOpen-labelSystemic therapyPFS-HRPrimary endpointARC-9: A randomized study to evaluate etrumadenant based treatment combinations in previously treated metastatic colorectal cancer (mCRC).
Wainberg Z, Han S, Lee S, Lee K, Kopetz S, Mizrahi J, Hong Y, Ghiringhelli F, Italiano A, Tougeron D, Beagle B, Boakye M, Zhao T, Rhee J, Nuyten D, Cecchini M. ARC-9: A randomized study to evaluate etrumadenant based treatment combinations in previously treated metastatic colorectal cancer (mCRC). Journal Of Clinical Oncology 2024, 42: 3508-3508. DOI: 10.1200/jco.2024.42.16_suppl.3508.Peer-Reviewed Original ResearchProgression-free survivalMetastatic colorectal cancerOverall survivalCohort BActivation of effector T cellsManagement of metastatic colorectal cancerAnti-PD-1 antibodyTreat metastatic colorectal cancerTreated with 5-FURandomized phase II clinical trialIrinotecan-containing regimensPhase Ib/II trialPhase II clinical trialEffector T cellsAdenosine receptor blockadeCohort of patientsII clinical trialsIrinotecan regimensMFOLFOX-6OS improvementReceptor blockadePrimary endpointProspective trialsReceptor antagonistSecondary endpoints
2022
Hybrid-control arm construction using historical trial data for an early-phase, randomized controlled trial in metastatic colorectal cancer
Li C, Ferro A, Mhatre SK, Lu D, Lawrance M, Li X, Li S, Allen S, Desai J, Fakih M, Cecchini M, Pedersen KS, Kim TY, Reyes-Rivera I, Segal NH, Lenain C. Hybrid-control arm construction using historical trial data for an early-phase, randomized controlled trial in metastatic colorectal cancer. Communications Medicine 2022, 2: 90. PMID: 35856081, PMCID: PMC9287310, DOI: 10.1038/s43856-022-00155-y.Peer-Reviewed Original ResearchMetastatic colorectal cancerExperimental armColorectal cancerMetastatic colorectal cancer (mCRC) trialsMetastatic colorectal cancer patientsPhase Ib/IITrial dataHistorical trial dataColorectal cancer trialsDisease control rateObjective response ratePhase 3 trialProgression-free survivalColorectal cancer patientsStandardized mortality ratioEarly phase trialsEarly phase clinical developmentLogistic regression modelsMultiple experimental armsPrimary endpointOverall survivalPrior linesEfficacy signalsSafety profileCombination therapy
2021
ARC-9: Phase Ib/II study to evaluate etrumadenant (AB928)-based treatment combinations in patients with metastatic colorectal cancer (mCRC).
Cecchini M, Krishnan K, Giafis N, Scott J, Quah C, Bendell J. ARC-9: Phase Ib/II study to evaluate etrumadenant (AB928)-based treatment combinations in patients with metastatic colorectal cancer (mCRC). Journal Of Clinical Oncology 2021, 39: tps150-tps150. DOI: 10.1200/jco.2021.39.3_suppl.tps150.Peer-Reviewed Original ResearchMetastatic colorectal cancerStandard-of-careStandard-of-care armMFOLFOX-6Cohort BCohort AActivation of effector T cellsModified 5-fluorouracilTreated with FOLFOXDying cancer cellsDose-escalation studyEffector T cellsPhase Ib/II studyAdenosine receptor blockadeAdenosine receptor antagonistPhase 1b/2Escalation studyCurative intentReceptor blockadeOpen-labelImmunosuppressive adenosineCombination therapyPrimary endpointReceptor antagonistCohort C
2020
A phase 1b expansion study of TAS‐102 with oxaliplatin for refractory metastatic colorectal cancer
Cecchini M, Kortmansky JS, Cui C, Wei W, Thumar JR, Uboha NV, Hafez N, Lacy J, Fischbach NA, Sabbath KD, Gomez CM, Sporn JR, Stein S, Hochster HS. A phase 1b expansion study of TAS‐102 with oxaliplatin for refractory metastatic colorectal cancer. Cancer 2020, 127: 1417-1424. PMID: 33351187, PMCID: PMC8085021, DOI: 10.1002/cncr.33379.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsDrug Administration ScheduleDrug CombinationsDrug Resistance, NeoplasmFemaleFluorouracilHumansIrinotecanLeucovorinMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinProgression-Free SurvivalPyrrolidinesResponse Evaluation Criteria in Solid TumorsThymineTrifluridineConceptsMetastatic colorectal cancerOverall response rateRefractory metastatic colorectal cancerProgression-free survivalTAS-102Colorectal cancerDay 1Primary endpointOverall survivalDose escalationDay 5Median progression-free survivalPhase 1b studyMedian overall survivalResponse Evaluation CriteriaTreat populationDose expansionPartial responseStandard dosesUnexpected side effectsStudy treatmentTumor shrinkageUnexpected toxicitiesSide effectsNovel antimetabolite