2024-516937-10-01RecruitingPhase 3
Safe Stop Trial Melanoma
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 21 Nov 2024
- Start date
- 18 Dec 2024
- Lead sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Diseases
- Melanoma
- EU CT number
- 2024-516937-10-01
- EudraCT number
- 2018-001384-23
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 200
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic melanoma who are being treated with nivolumab or pembrolizumab as first treatment and are willing to stop it after a complete or partial response.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Advanced or metastatic melanoma with measurable tumour lesions (RECIST v1.1) on a CT scan taken when PD-1 treatment started
- Earlier treatment
- Currently on first-line nivolumab or pembrolizumab for advanced or metastatic melanoma. Earlier drug treatment, including immunotherapy, given as (neo)adjuvant treatment before surgery is allowed.
Main reasons for not taking part
- Taking other anti-cancer drugs at the same time, such as a BRAF inhibitor or ipilimumab (anti-CTLA4)
- Taking a PD-1 blocker other than nivolumab or pembrolizumab
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting | Amsterdam | Netherlands | Recruiting |
| Amsterdam UMC Stichting | Amsterdam | Netherlands | Recruiting |
| Amphia Hospital | Breda | Netherlands | Recruiting |
| Máxima Medisch Centrum | Eindhoven | Netherlands | Recruiting |
| Medisch Spectrum Twente | Enschede | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen | Groningen | Netherlands | Recruiting |
| Zuyderland Medisch Centrum Stichting | Heerlen | Netherlands | Recruiting |
| Medisch Centrum Leeuwarden B.V. | Leeuwarden | Netherlands | Recruiting |
| Leids Universitair Medisch Centrum (LUMC) | Leiden | Netherlands | Recruiting |
| Academisch Ziekenhuis Maastricht | Maastricht | Netherlands | Recruiting |
| Radboud universitair medisch centrum Stichting | Nijmegen | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | Recruiting |
| Isala Klinieken Stichting | Zwolle | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.