biostudies-literatureConsoli FNovartis (Italy)4072https://www.ebi.ac.uk/biostudies/studies/S-EPMC11640251biostudies-literatureUnknown16(23)<b>Background/Objective</b>: Dabrafenib and trametinib (D + T) have been approved for the treatment of stage III melanoma with BRAF V600E V600K mutations in an adjuvant setting, based on the results from the COMBI-AD trial. To provide early access to this combination therapy prior to its commercial availability in Italy, a Managed Access Program (MAP) was run in Italy from June 2018 to December 2019. <b>Methods</b>: The MADAM (Maximing ADjuvAnt MAP) study is an Italian retrospective-prospective observational study that included patients who received at least one dose of D + T through the MAP. The primary endpoints were relapse-free survival (RFS) and overall survival (OS). <b>Results</b>: This interim analysis presents findings after the first 24 months of follow-up. A total of 310 patientCancersRetrospective-Prospective Observational Study of Italian Patients Treated in Melanoma Adjuvant Cohort MAP-MADAM (Maximing ADjuvAnt MAP): Interim Analysis.PMC11640251NAMorgese FTucci MPigozzo JConsoli FSimeone EQuaglino PMorelli MFMarcon IValsecchi DTronconi MCMerelli BDel Vecchio MSpagnolo FTroiani TMelotti BGrosso FfalseRetrospective-Prospective Observational Study of Italian Patients Treated in Melanoma Adjuvant Cohort MAP-MADAM (Maximing ADjuvAnt MAP): Interim Analysis.<b>Background/Objective</b>: Dabrafenib and trametinib (D + T) have been approved for the treatment of stage III melanoma with BRAF V600E V600K mutations in an adjuvant setting, based on the results from the COMBI-AD trial. To provide early access to this combination therapy prior to its commercial availability in Italy, a Managed Access Program (MAP) was run in Italy from June 2018 to December 2019. <b>Methods</b>: The MADAM (Maximing ADjuvAnt MAP) study is an Italian retrospective-prospective observational study that included patients who received at least one dose of D + T through the MAP. The primary endpoints were relapse-free survival (RFS) and overall survival (OS). <b>Results</b>: This interim analysis presents findings after the first 24 months of follow-up. A total of 310 patient2024-01-01T00:00:00Z2024 Dec2025-04-03T23:27:04.401Z2025-04-03T23:27:04.401ZS-EPMC116402513968225810.3390/cancers16234072