PEMBROLIZUMAB for Melanoma|Advanced or metastatic melanoma

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 year"}
• {"criterion_text":"- Advanced or metastatic melanoma"}
• {"criterion_text":"- Current treatment with first-line nivolumab or pembrolizumab for advanced or metastatic melanoma; previous systemic treatment, including immunotherapy, in (neo)adjuvant setting for resectable melanoma is allowed"}
• {"criterion_text":"- Documented target lesion(s) according to RECIST v1.1 on diagnostic CT at start of PD-1 blockade with nivolumab or pembrolizumab"}
• {"criterion_text":"- Documented tumor response evaluation every 12±1 weeks according to RECIST v1.1 (35) using a diagnostic CT as per standard practice"}
• {"criterion_text":"- Presence of MRI brain for the screening of brain metastases (prior to discontinuation of PD-1 blockade)"}
• {"criterion_text":"- Willingness to discontinue nlvolumab or pembrolizumab within 6 (+1) weeks weeks after confirmation of CR or PR before the full period of 2 years therapy"}

Exclusion criteria

• {"criterion_text":"- Concomitant systemic therapies with other anti-cancer agents, e.g. BRAF-inhibitor, anti-CTLA4 (e.g. ipilimumab), or other PD-1 blockade than nlvolumab or pembrollzumab"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Ongoing responses (CR and PR) assessed according to RECIST v1.1 at 24 months after first start of nivolumab/pembrolizumab"}

Secondary endpoints

• {"endpoint_text":"- 1a. Total duration of tumor response after first documented CR or PR followed by treatment interruption","definition_or_measurement_approach":""}
• {"endpoint_text":"- 1 b. Duration of tumor response (CR and PR) after discontinuation of PD-1 blockade","definition_or_measurement_approach":""}
• {"endpoint_text":"- 2. PFS from start of first-line monotherapy with PD-1 blockade (i.e. nivolumab or pembrolizumab) until first PD (PFS1)","definition_or_measurement_approach":"Progression-free survival measured from start of first-line PD-1 monotherapy until first documented progressive disease (PFS1)"}
• {"endpoint_text":"- 3a. Rate of reintroduction of monotherapy with PD-1 blockade (i.e. nivolumab or pembrolizumab) upon first PD","definition_or_measurement_approach":""}
• {"endpoint_text":"- 3b. Rate of introduction of other systemic salvage therapy (i.e. other than monotherapy PD-1 blockade) upon first PD","definition_or_measurement_approach":""}
• {"endpoint_text":"- 4a. Best tumor response on rechallenge with monotherapy PD-1 blockade (i.e. nivolumab or pembrolizumab)","definition_or_measurement_approach":""}
• {"endpoint_text":"- 4b. Best tumor response after introduction of other systemic salvage therapy (i.e. other than monotherapy PD-1 blockade)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Sa. PFS after reintroduction of monotherapy PD-1 blockade (i.e. nivolumab, or pembrolizumab) (PFS2a)","definition_or_measurement_approach":"Progression-free survival after reintroduction of PD-1 monotherapy (PFS2a)"}
• {"endpoint_text":"- Sb. PFS after introduction other systemic salvage therapy (i.e. other than monotherapy PD- 1 blockade) (PFS2b)","definition_or_measurement_approach":"Progression-free survival after introduction of other systemic salvage therapy (PFS2b)"}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Total PFS defined as period from initial start of PD-1 blockade until final progressive disease, including periods after discontinuation and any (re-)introduction of PD-1 therapy or other salvage therapy"}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Dutch-language description of total PFS (same definition as above)"}
• {"endpoint_text":"- 7. Rate of grade 3-4 AEs after early discontinuation or reintroduction of nivolumab/pembrolizumab monotherapy","definition_or_measurement_approach":"Rate of adverse events graded 3-4 (severity) following early discontinuation or reintroduction of PD-1 monotherapy"}
• {"endpoint_text":"- 8. Change in tumor burden since the start and after early discontinuation of PD-1 blockade","definition_or_measurement_approach":""}
• {"endpoint_text":"- 9. Change in Qol after discontinuation of PD-1 blockade measured at different time point","definition_or_measurement_approach":"Quality of life changes measured at multiple time points after discontinuation (specific instruments/time points not specified)"}
• {"endpoint_text":"- 10. Change in fear of disease recurrence/progression","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in productivity (paid and unpaid work) after discontinuation of PD-1 blockad","definition_or_measurement_approach":""}
• {"endpoint_text":"- 12. Change in healthcare resource (within and outside the hospital) after discontinuation of PD-1 blockade","definition_or_measurement_approach":""}
• {"endpoint_text":"- 13. Change in hours of informal care after discontinuation of PD-1 blockade","definition_or_measurement_approach":""}
• {"endpoint_text":"- Qol at disease progression and restart of systemic therapy (when applicable)","definition_or_measurement_approach":""}
• {"endpoint_text":"- 14.\tVerandering in Qol bij PD en herstart systemlsche theraple (indien van toepassing)","definition_or_measurement_approach":"Dutch-language QoL endpoint at progression and restart of systemic therapy (definition/instruments not specified)"}

Netherlands

Earliest CTIS Part Ii Submission Date

11-12-2024

Latest Decision Or Authorization Date

18-12-2024

Processing Time Days

7

Number Of Sites

14

Number Of Participants

200

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands