Cutaneous squamous cell carcinoma
Conditions
Brief summary
A clinical complete remission rate of at least 30% at 12, 18 and 24 months FU after only immunotherapy, without surgery, radiotherapy, or maintenance immunotherapy.
Detailed description
Rate and type of immune-related AEs (CTCAE v5.0, Clavien-Dindo);, Health-related QoL (EORTC QLQ-C30) between responders (undergoing only immunotherapy) and non-responders (undergoing standard of care after neoadjuvant immunotherapy);, Treatment duration and treatment stops;, Survival (DSS, RFS (RECIST v1.1), EFS and OS) at 12, 18 and 24 months FU;, Survival of MATISSE 2 patients will also be compared to survival of a historic cohort of CSCC patients previously treated at the NKI-AVL with standard of care surgery ± RT without neoadjuvant immunotherapy;, Healthcare needs and consumption will be compared between MATISSE 2 responders (undergoing only immunotherapy) and non-responders (undergoing standard of care after neoadjuvant immunotherapy);, Healthcare utilisation of MATISSE 2 patients will also be compared to healthcare utilisation of a historic cohort of CSCC patients previously treated at the NKI-AVL with standard of care surgery ± RT without neoadjuvant immunotherapy;, Cost-effectiveness will be assessed for MATISSE 2 responders (undergoing only immunotherapy) and non-responders (undergoing standard of care after neoadjuvant immunotherapy);, Costs of MATISSE 2 patients will be compared to costs of a historic cohort of CSCC patients previously treated at the NKI-AVL with standard of care surgery ± RT without neoadjuvant immunotherapy;
Interventions
DRUGYERVOY 5 mg/ml concentrate for solution for infusion
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A clinical complete remission rate of at least 30% at 12, 18 and 24 months FU after only immunotherapy, without surgery, radiotherapy, or maintenance immunotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate and type of immune-related AEs (CTCAE v5.0, Clavien-Dindo);, Health-related QoL (EORTC QLQ-C30) between responders (undergoing only immunotherapy) and non-responders (undergoing standard of care after neoadjuvant immunotherapy);, Treatment duration and treatment stops;, Survival (DSS, RFS (RECIST v1.1), EFS and OS) at 12, 18 and 24 months FU;, Survival of MATISSE 2 patients will also be compared to survival of a historic cohort of CSCC patients previously treated at the NKI-AVL with standard of care surgery ± RT without neoadjuvant immunotherapy;, Healthcare needs and consumption will be compared between MATISSE 2 responders (undergoing only immunotherapy) and non-responders (undergoing standard of care after neoadjuvant immunotherapy);, Healthcare utilisation of MATISSE 2 patients will also be compared to healthcare utilisation of a historic cohort of CSCC patients previously treated at the NKI-AVL with standard of care surgery ± RT without neoadjuvant immunotherapy;, Cost-effect | — |
Countries
Netherlands
Outcome results
None listed