Advanced melanoma
Conditions
Brief summary
6 months progression-free survival rate, 6 months overall survival rate
Detailed description
Overall progression-free survival, Overall survival, Overall response rate according to modified RECIST 1.1, Extracranial response rate in extracranial lesions according to modified RECIST 1.1, Intracranial response rate in intracranial lesions according to modified RECIST 1.1, Intracranial clinical benefit rate (CR+PR+SD) – proportion of patients with an overall complete, partial response or stable disease ≥ 6 months according to modified RECIST 1.1, Blood and tissue biomarkers of response and progression
Interventions
DRUGDABRAFENIB
DRUGENCORAFENIB
DRUGBINIMETINIB
DRUGTRAMETINIB
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGYERVOY 5 mg/ml concentrate for solution for infusion
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Region Hovedstaden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 months progression-free survival rate, 6 months overall survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall progression-free survival, Overall survival, Overall response rate according to modified RECIST 1.1, Extracranial response rate in extracranial lesions according to modified RECIST 1.1, Intracranial response rate in intracranial lesions according to modified RECIST 1.1, Intracranial clinical benefit rate (CR+PR+SD) – proportion of patients with an overall complete, partial response or stable disease ≥ 6 months according to modified RECIST 1.1, Blood and tissue biomarkers of response and progression | — |
Countries
Denmark
Outcome results
None listed