Previously treated unresectable or metastatic BRAFV600 or NRAS mutant melanoma
Conditions
Brief summary
Confirmed ORR using RECIST v1.1, per local assessment
Detailed description
Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) including changes in laboratory values, vital signs and cardiac assessment, Tolerability: Dose interruptions, reductions, and permanent discontinuations of study treatments, DoR, PFS and DCR using RECIST v1.1, per local assessment, DoR, PFS, DCR and ORR, assessed using RECIST v1.1, per central assessment for all participants (selection and expansion) for the combination arms that moved to expansion, Overall survival (OS), Serum/plasma concentration and pharmacokinetic parameters of each combination regimen
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmed ORR using RECIST v1.1, per local assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) including changes in laboratory values, vital signs and cardiac assessment, Tolerability: Dose interruptions, reductions, and permanent discontinuations of study treatments, DoR, PFS and DCR using RECIST v1.1, per local assessment, DoR, PFS, DCR and ORR, assessed using RECIST v1.1, per central assessment for all participants (selection and expansion) for the combination arms that moved to expansion, Overall survival (OS), Serum/plasma concentration and pharmacokinetic parameters of each combination regimen | — |
Countries
Belgium, France, Germany, Italy
Outcome results
None listed