Safe Stop Trial Melanoma
Key facts
- Where
- Amsterdam, Breda, Eindhoven, Enschede, Groningen, Heerlen, Leeuwarden, Leiden, Maastricht, Nijmegen, Rotterdam, Utrecht és Zwolle, HollandiaSee the 14 sites
- Phase
- 3. fázis
Where in Hollandia
- Amsterdam UMC StichtingAmsterdam, HollandiaTaking people
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdam, HollandiaTaking people
- Amphia HospitalBreda, HollandiaTaking people
- Máxima Medisch CentrumEindhoven, HollandiaTaking people
- Medisch Spectrum TwenteEnschede, HollandiaTaking people
- Universitair Medisch Centrum GroningenGroningen, HollandiaTaking people
- Zuyderland Medisch Centrum StichtingHeerlen, HollandiaTaking people
- Medisch Centrum Leeuwarden B.V.Leeuwarden, HollandiaTaking people
- Leids Universitair Medisch Centrum (LUMC)Leiden, HollandiaTaking people
- Academisch Ziekenhuis MaastrichtMaastricht, HollandiaTaking people
- Radboud universitair medisch centrum StichtingNijmegen, HollandiaTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaTaking people
- Universitair Medisch Centrum UtrechtUtrecht, HollandiaTaking people
- Isala Klinieken StichtingZwolle, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Trial code
- EU 2024-516937-10-01
- Record updated
- 2025. augusztus 5.
- Original description
The primary objective of this study is the rate of ongoing response in patients with advanced and metastatic melanoma who discontinue first-line monotherapy with nivolumab or pembrolizumab upon achieving a CR or PR.Read full original descriptionShow less
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
The primary objective of this study is the rate of ongoing response in patients with advanced and metastatic melanoma who discontinue first-line monotherapy with nivolumab or pembrolizumab upon achieving a CR or PR.
Inclusion: Age ≥ 18 year; Advanced or metastatic melanoma; 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; Documented target lesion(s) according to RECIST v1.1 on diagnostic CT at start of PD-1 blockade with nivolumab or pembrolizumab; Documented tumor response evaluation every 12±1 weeks according to RECIST v1.1 (35) using a diagnostic CT as per standard practice; Presence of MRI brain for the screening of brain metastases (prior to discontinuation of PD-1 blockade); 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: 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.