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