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 endpointA phase I study of ATR inhibitor BAY1895344 (elimusertib) plus topotecan (ETCTN 10402): Results of dose escalation.
Stockton S, Shyr C, Cecchini M, Aljumaily R, Halfdanarson T, Sonbol M, Whisenant J, Ivy S, LoRusso P, Das S, Gore S, Berlin J, Beumer J, Heumann T. A phase I study of ATR inhibitor BAY1895344 (elimusertib) plus topotecan (ETCTN 10402): Results of dose escalation. Journal Of Clinical Oncology 2024, 42: 3076-3076. DOI: 10.1200/jco.2024.42.16_suppl.3076.Peer-Reviewed Original ResearchMaximum tolerated doseDose escalationDose levelsMedian progression-free survivalRecommended phase 2 doseRefractory advanced solid tumorsResults of dose escalationTreatment-related adverse eventsSmall cell lung cancerDisease control ratePhase 2 dosePhase Ia studyDose-limiting toxicityProgression-free survivalAdvanced solid tumorsPhase I studyCell lung cancerAnti-tumor activityExpansion cohortPartial responseTolerated doseTopotecan exposureStudy drugCancer xenograftsRespiratory failureAbstract B117: Phase 1 study of CM24 in combination with nivolumab in patients with advanced pancreatic cancer - Survival, potential biomarker and effect on neutrophil extracellular traps (NETs)
Borazanci E, Pant S, Perets R, Golan T, Al Hallak M, Cecchini M, Maierson T, David H, Schickler M, Reuveni H. Abstract B117: Phase 1 study of CM24 in combination with nivolumab in patients with advanced pancreatic cancer - Survival, potential biomarker and effect on neutrophil extracellular traps (NETs). Cancer Research 2024, 84: b117-b117. DOI: 10.1158/1538-7445.panca2023-b117.Peer-Reviewed Original ResearchPancreatic ductal adenocarcinoma patientsTumor-infiltrating lymphocytesPancreatic ductal adenocarcinomaNeutrophil extracellular trapsCarcinoembryonic antigen cell adhesion molecule 1Dose-escalation partPancreatic cancer survivalImmune evasionExtracellular trapsEscalation partPatient biopsiesPotential biomarkersRandomized phase 2 studyCompared to healthy volunteersControl immune evasionDisease control ratePhase 1/2 studyAnti-tumor immunitySecond-line therapyCancer survivalPhase 2 studyPhase 1 studyCell adhesion molecule 1Adhesion molecule 1Patient survival data
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
2020
Abstract LB-387: Efficacy and safety of AB928 plus modified FOLFOX-6 (mFOLFOX-6) in participants with metastatic colorectal cancer (mCRC): Initial results at the recommended dose for expansion (ARC-3)
Cecchini M, Modiano M, Braiteh F, Gardner O, Gilbert H, DiRenzo D, Seitz L, Walters M, Yin F, Woloski R, Paoloni M, Chung K. Abstract LB-387: Efficacy and safety of AB928 plus modified FOLFOX-6 (mFOLFOX-6) in participants with metastatic colorectal cancer (mCRC): Initial results at the recommended dose for expansion (ARC-3). Cancer Research 2020, 80: lb-387-lb-387. DOI: 10.1158/1538-7445.am2020-lb-387.Peer-Reviewed Original ResearchModified FOLFOX-6Metastatic colorectal cancerAdverse eventsPhase 1bFOLFOX-6Stable diseaseColorectal cancerAnti-tumor immune responseECOG performance status 0Recommended doseAssociated with disease controlExploratory biomarker analysesTumor shrinkage >Disease control rateDying cancer cellsGrade 3 AEsPerformance status 0Dose-escalation studyAdenosine receptor blockadeOpen-label studyAmerican Association for Cancer ResearchAdenosine receptor antagonistRelease of ATPNext gene sequencingAdenosine axisAbstract CT246: Consortium-IO: A safety and efficacy study of VE800 in combination with nivolumab in previously treated patients with select advanced metastatic cancers
Davar D, Wang J, Cecchini M, Wainberg Z, Gutierrez M, Turk A, Szabady R, Norman J, Olle B, Roberts B, Bobilev D. Abstract CT246: Consortium-IO: A safety and efficacy study of VE800 in combination with nivolumab in previously treated patients with select advanced metastatic cancers. Cancer Research 2020, 80: ct246-ct246. DOI: 10.1158/1538-7445.am2020-ct246.Peer-Reviewed Original ResearchPD-1 blockadeResponse to PD-1 blockadeDisease control rateDose-limiting toxicityProgression-free survivalDuration of responseOverall survivalTreated patientsResistance to PD-1 blockadeCD8+ T cell infiltrationCancer patientsCD103+ dendritic cellsCourses of oral vancomycinClinical activitySimon 2-stage designMajor histocompatibilityT cell infiltrationMicrosatellite-stablePhase I studyEfficacy studiesAmerican Association for Cancer ResearchMultiple tumor modelsAdvanced metastatic cancerSingle dose levelAnti-tumor activity
2019
A phase I study of TAS-102 in combination with oxaliplatin (TAS-OX) for refractory metastatic colorectal cancer (mCRC).
Cecchini M, Kortmansky J, Lacy J, Fischbach N, Thumar J, Sabbath K, Gomez C, Sporn J, Stein S, Hochster H. A phase I study of TAS-102 in combination with oxaliplatin (TAS-OX) for refractory metastatic colorectal cancer (mCRC). Journal Of Clinical Oncology 2019, 37: 630-630. DOI: 10.1200/jco.2019.37.4_suppl.630.Peer-Reviewed Original ResearchDisease control rateMetastatic colorectal cancerTAS-102Progressive diseaseDay 1Thymidine phosphorylase inhibitorRefractory metastatic colorectal cancerDose-escalating studyECOG PS 0Phase II doseEfficacy of oxaliplatinUsual laboratory parametersEligible patientsEvaluable patientsMeasurable diseaseUnexpected AEsStarting doseTreatment discontinuationPS 0Improved survivalLaboratory parametersOral combinationColorectal cancerPatient populationControl rate