renal cell carcinoma
Conditions
Brief summary
12-month progression-free survival: 12-month progression-free survival after randomization, defined as the absence of radiologically or clinically confirmed disease progression according to RECIST 1.1 criteria or death from any cause within 12 months of randomization.
Detailed description
Progression-free survival: PFS, defined as the time from randomization to the first documented disease progression according to RECIST 1.1 criteria or death from any cause., Overall survival: Overall survival, defined as the time from randomization to death from any cause., Health-related quality of life: Change in scores of the EORTC QLQ-C30 questionnaire and the HADS scale compared to baseline at predefined study time points., Treatment emergent adverse events (CTCAE v5.0)
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Institute Of Oncology Ljubljana
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month progression-free survival: 12-month progression-free survival after randomization, defined as the absence of radiologically or clinically confirmed disease progression according to RECIST 1.1 criteria or death from any cause within 12 months of randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival: PFS, defined as the time from randomization to the first documented disease progression according to RECIST 1.1 criteria or death from any cause., Overall survival: Overall survival, defined as the time from randomization to death from any cause., Health-related quality of life: Change in scores of the EORTC QLQ-C30 questionnaire and the HADS scale compared to baseline at predefined study time points., Treatment emergent adverse events (CTCAE v5.0) | — |
Outcome results
None listed