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Taking people in NetherlandsPhase 3

Tests stopping and restarting immune treatment in advanced melanoma

Tests stopping nivolumab or pembrolizumab once melanoma shows response, in adults.

Key facts

Who runs it
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Where
Amsterdam, Breda, Eindhoven, Enschede, Groningen, Heerlen, Leeuwarden, Leiden, Maastricht, Nijmegen, Rotterdam, Utrecht, and Zwolle, NetherlandsSee the 14 sites
Registry title
Safe Stop Trial Melanoma
Status
Recruiting
Phase
Phase 3
People taking part
200 people, planned
Started
18 Dec 2024
Expected to end
10 Aug 2033
Type of study
Interventional
Record updated
5 August 2025

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Netherlands

  • Amsterdam UMC StichtingAmsterdam, NetherlandsTaking people
  • Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdam, NetherlandsTaking people
  • Amphia HospitalBreda, NetherlandsTaking people
  • Máxima Medisch CentrumEindhoven, NetherlandsTaking people
  • Medisch Spectrum TwenteEnschede, NetherlandsTaking people
  • Universitair Medisch Centrum GroningenGroningen, NetherlandsTaking people
  • Zuyderland Medisch Centrum StichtingHeerlen, NetherlandsTaking people
  • Medisch Centrum Leeuwarden B.V.Leeuwarden, NetherlandsTaking people
  • Leids Universitair Medisch Centrum (LUMC)Leiden, NetherlandsTaking people
  • Academisch Ziekenhuis MaastrichtMaastricht, NetherlandsTaking people
  • Radboud universitair medisch centrum StichtingNijmegen, NetherlandsTaking people
  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
  • Universitair Medisch Centrum UtrechtUtrecht, NetherlandsTaking people
  • Isala Klinieken StichtingZwolle, NetherlandsTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests stopping and restarting immune treatment in advanced melanomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
5 August 2025