Completely resected Stage IIb/c melanoma
Conditions
Brief summary
RFS
Detailed description
OS, AE, clinical laboratory values, vital signs, ECGs, or other safety biomarkers, DMFS, Objective response rates (if applicable), Duration of treatment on next-line therapies, Progression-free survival through next-line therapy (PFS2) is defined as the time from randomization to second recurrence/objective disease progression after the start of the next-line of systemic anti-cancer therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first, End-of-next-line-treatment: To be used for situations where PFS2 cannot be reliably determined. Event defined as end or discontinuation of next-line treatment, second objective disease progression, or death from any cause, whichever occurs first.
Interventions
DRUG5% Dextrose for Injection; Solution for injection
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RFS | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, AE, clinical laboratory values, vital signs, ECGs, or other safety biomarkers, DMFS, Objective response rates (if applicable), Duration of treatment on next-line therapies, Progression-free survival through next-line therapy (PFS2) is defined as the time from randomization to second recurrence/objective disease progression after the start of the next-line of systemic anti-cancer therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first, End-of-next-line-treatment: To be used for situations where PFS2 cannot be reliably determined. Event defined as end or discontinuation of next-line treatment, second objective disease progression, or death from any cause, whichever occurs first. | — |
Countries
Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Romania, Spain, Sweden
Outcome results
None listed