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

Melanoma

The primary endpoint of this study is the rate of ongoing responses (CR and PR) according to RECIST v1 .1 (35) at 24 months after first start of nivolumab/pembrolizumab

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)

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Netherlands