A Clinical Development Paradigm for Cancer Vaccines and Related Biologics
Hoos A, Parmiani G, Hege K, Sznol M, Loibner H, Eggermont A, Urba W, Blumenstein B, Sacks N, Keilholz U, Nichol G. A Clinical Development Paradigm for Cancer Vaccines and Related Biologics. Journal Of Immunotherapy 2007, 30: 1-15. PMID: 17198079, DOI: 10.1097/01.cji.0000211341.88835.ae.Peer-Reviewed Original ResearchConceptsTherapeutic cancer vaccinesPhase 2 trialCancer vaccinesEfficacy trialsPrinciple trialImmune responseEnd pointCytotoxic agentsCombination therapyRelated biologicsBiologic activitySingle-arm phase 2 trialRandomized phase 2 trialClinical development challengesRandomized phase 2Primary end pointStudy end pointTumor response ratePhase 3 studyPhase 3 trialClinical end pointsNovel cancer vaccinesDifferent clinical characteristicsSuch immune responsesClinical development plan