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
- Conditions
- malignant melanomaMelanoma10040900
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
- 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 diagnostic CT at start of PD-1 blockade with nivolumab or
pembrolizumab
• For patients with CR on a diagnostic CT at response evaluation, a low dose-CT
(which is usually part of 18FDG-PET/CT) is allowed at baseline
• For patients with PR on a diagnostic CT at response evaluation, a low dose-CT
(which is usually part of 18FDG-PET/CT) is allowed if sufficient target lesions
are measurable for response evaluation according to RECIST v1.1 criteria. In
this specific case the sponsor should be consulted.
- documented tumor response evaluation every 12 (±1) weeks according to RECIST
v1.1 (34) 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 nivolumab or pembrolizumab within 6 (+1) weeks
weeks after
confirmation of CR or PR before the full period of 2 years therapy
Concomitant systemic therapies with other anti-cancer agents, e.g.
BRAF-inhibitor, anti-CTLA4 (e.g. ipilimumab), or other PD-1 blockade than
nivolumab or pembrolizumab
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the rate of ongoing responses (CR and PR) according to<br /><br>RECIST v1.1 at 24 months after first start of nivolumab or pembrolizumab.</p><br>
- Secondary Outcome Measures
Name Time Method