Unresectable or Metastatic Melanoma
Conditions
Brief summary
Objective response by week 49
Detailed description
Secondary Efficacy Endpoints: • Objective response at week 17 • PFS • OS • DOR, Secondary Endpoints Safety-related Endpoints: • Treatment-emergent adverse events • Treatment-emergent serious adverse events • Treatment-emergent adverse events of interest, Secondary Endpoints Immunogenicity-related Endpoints: • Incidence of ADAs, Secondary Endpoints Pharmacokinetic-related Endpoints: • ABP 206 and nivolumab serum (trough) concentrations
Interventions
DRUGABP 206
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response by week 49 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoints: • Objective response at week 17 • PFS • OS • DOR, Secondary Endpoints Safety-related Endpoints: • Treatment-emergent adverse events • Treatment-emergent serious adverse events • Treatment-emergent adverse events of interest, Secondary Endpoints Immunogenicity-related Endpoints: • Incidence of ADAs, Secondary Endpoints Pharmacokinetic-related Endpoints: • ABP 206 and nivolumab serum (trough) concentrations | — |
Countries
Croatia, Czechia, Estonia, France, Germany, Hungary, Italy, Lithuania, Netherlands, Portugal, Romania, Spain
Outcome results
None listed