Safe Stop Trial: observational study of the STOP & GO strategy of PD-1 blockade in advanced melanoma patients upon achieving a complete or partial response

简要总结

主要结局

次要结局

• 1a. Total duration of tumor response after first documented CR or PR followed by treatment interruption
• 1 b. Duration of tumor response (CR and PR) after discontinuation of PD-1 blockade
• 2. PFS from start of first-line monotherapy with PD-1 blockade (i.e. nivolumab or pembrolizumab) until first PD (PFS1)
• 3a. Rate of reintroduction of monotherapy with PD-1 blockade (i.e. nivolumab or pembrolizumab) upon first PD
• 3b. Rate of introduction of other systemic salvage therapy (i.e. other than monotherapy PD-1 blockade) upon first PD
• 4a. Best tumor response on rechallenge with monotherapy PD-1 blockade (i.e. nivolumab or pembrolizumab)
• 4b. Best tumor response after introduction of other systemic salvage therapy (i.e. other than monotherapy PD-1 blockade)
• Sa. PFS after reintroduction of monotherapy PD-1 blockade (i.e. nivolumab, or pembrolizumab) (PFS2a)
• Sb. PFS after introduction other systemic salvage therapy (i.e. other than monotherapy PD- 1 blockade) (PFS2b)
• 6a. Total PFS (PFSTata1) defined as the period from initial start of PD-1 blockade until final PD (including period after discontinuation and (re-)introduction of nivolumab/ pembrolizumab or other salvage therapy)
• Totale PFS gedefinieerd als de periode vanaf de eerste start van PD-1-blokkering tot de uiteindelijke PD (inclusief periode na staken en bij (her)start van nivolumab/pemprolizumab of andere systemische therapie (PFStotaal)
• 7. Rate of grade 3-4 AEs after early discontinuation or reintroduction of nivolumab/pembrolizumab monotherapy
• 8. Change in tumor burden since the start and after early discontinuation of PD-1 blockade
• 9. Change in Qol after discontinuation of PD-1 blockade measured at different time point
• 10. Change in fear of disease recurrence/progression
• Change in productivity (paid and unpaid work) after discontinuation of PD-1 blockad
• 12. Change in healthcare resource (within and outside the hospital) after discontinuation of PD-1 blockade
• 13. Change in hours of informal care after discontinuation of PD-1 blockade
• Qol at disease progression and restart of systemic therapy (when applicable)
• 14. Verandering in Qol bij PD en herstart systemlsche theraple (indien van toepassing)