unresectable stage III – IV melanoma
Conditions
Brief summary
T cell subset frequencies (as percentage of parent), and systemic activation (determined as a 50 % or greater increase in expression of inducible T-cell costimulator (ICOS/CD278)) in PBMCs CD4+/CD8+ T cells at baseline and on-treatment in both groups.
Detailed description
Safety of i.d. ipilimumab (group 1 only): Adverse events using Common Terminology Criteria Adverse Events, version 5.0 (CTCAE 5.0), reported as frequency of treatment-related events. Grade 3 or higher will be reported separately.
Interventions
DRUGYERVOY 5 mg/ml concentrate for solution for infusion
Sponsors
Stichting Amsterdam UMC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T cell subset frequencies (as percentage of parent), and systemic activation (determined as a 50 % or greater increase in expression of inducible T-cell costimulator (ICOS/CD278)) in PBMCs CD4+/CD8+ T cells at baseline and on-treatment in both groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of i.d. ipilimumab (group 1 only): Adverse events using Common Terminology Criteria Adverse Events, version 5.0 (CTCAE 5.0), reported as frequency of treatment-related events. Grade 3 or higher will be reported separately. | — |
Outcome results
None listed