Solid tumors
Conditions
Brief summary
The primary endpoint is the Disease Free Survival (DFS) rate at 24 months defined as the proportion of patients who have not suffered any of the following since the time of randomization: first documented recurrence of disease, new primary tumor or death due to any cause, whichever occurs first
Detailed description
DFS rate at 36, 48 and 60 months, OS (Overall Survival) after randomization, defined as the time from randomization to death from any cause, Incidence and severity of AEs, with severity determined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0), Change from baseline in targeted clinical laboratory test results, Tumor biomarker: Percentage of PDL1 positive cells versus DFS and OS, Genomics: Genomic alterations related to resistance to immunotherapy versus DFS and OS
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the Disease Free Survival (DFS) rate at 24 months defined as the proportion of patients who have not suffered any of the following since the time of randomization: first documented recurrence of disease, new primary tumor or death due to any cause, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS rate at 36, 48 and 60 months, OS (Overall Survival) after randomization, defined as the time from randomization to death from any cause, Incidence and severity of AEs, with severity determined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0), Change from baseline in targeted clinical laboratory test results, Tumor biomarker: Percentage of PDL1 positive cells versus DFS and OS, Genomics: Genomic alterations related to resistance to immunotherapy versus DFS and OS | — |
Countries
Spain