The participants must have a histologically confirmed diagnosis of resectable cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted).
Conditions
Brief summary
Event-Free Survival
Detailed description
Objective Response, Freedom from surgery, Pathological Complete Response, Major Pathological Response, Disease-Free Survival, Disease-Specific Survival, Overall Survival, Percentage of Participants Experiencing Adverse Events (AEs), Percentage of Participants Discontinuing Study Treatment Due to AEs, Change in score from baseline evaluated by: - Global Health Status/Quality of Life (QoL) score (QLQ-C30 Items 29 and 30), Change in score from baseline evaluated by: - Physical functioning score (QLQ-C30 Items 1 to 5), Change in score from baseline evaluated by: - Role functioning score (QLQ-C30 Items 6 and 7)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response, Freedom from surgery, Pathological Complete Response, Major Pathological Response, Disease-Free Survival, Disease-Specific Survival, Overall Survival, Percentage of Participants Experiencing Adverse Events (AEs), Percentage of Participants Discontinuing Study Treatment Due to AEs, Change in score from baseline evaluated by: - Global Health Status/Quality of Life (QoL) score (QLQ-C30 Items 29 and 30), Change in score from baseline evaluated by: - Physical functioning score (QLQ-C30 Items 1 to 5), Change in score from baseline evaluated by: - Role functioning score (QLQ-C30 Items 6 and 7) | — |
Countries
Belgium, Czechia, France, Germany, Hungary, Italy, Norway, Poland, Romania, Spain