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Safe Stop Onderzoek: het eerder staken van nivolumab of pembrolizumab bij patiŽnten met gevorderd melanoom die goed reageren op deze behandeling


- candidate number29607
- NTR NumberNTR7502
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-sep-2018
- Secondary IDsEudraCT: 2018-001384-23 ABR: NL65512.078.18
- Public TitleSafe Stop Onderzoek: het eerder staken van nivolumab of pembrolizumab bij patiŽnten met gevorderd melanoom die goed reageren op deze behandeling
- Scientific TitleSafe Stop Trial: observational study of the STOP & GO strategy of PD-1 blockade in advanced melanoma patients upon achieving a complete (CR) or partial response (PR)
- ACRONYMSafe Stop Trial
- hypothesis
- Healt Condition(s) or Problem(s) studiedMelanoma, Nivolumab, Pembrolizumab
- Inclusion criteria- 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 diagnostic CT at baseline (< 4 weeks prior to first administration of nivolumab or pembrolizumab) and every 12 weeks after start of PD-1 blockade with nivolumab or pembrolizumab
- documented tumor response evaluation every 12 weeks according to RECIST v.1.1 (Eisenhauer et al., 2009) using a diagnostic CT as per standard practice
- having confirmed CR (with an interval of 61 weeks after first documentation) or an ongoing PR (with an interval of 12 weeks after first documentation) according to RECIST v.1.1 (Eisenhauer et al., 2009) using a diagnostic CT
- willingness to discontinue nivolumab or pembrolizumab within 4 weeks after confirmation of CR or PR before the full period of 2 years therapy
- signed and dated informed consent form
- Exclusion criteria- 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
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 22-okt-2018
- planned closingdate22-okt-2020
- Target number of participants200
- InterventionsDiscontinuation of PD-1 blockade (nivolumab or pembrolizumab) at achieving CR or PR.
- Primary outcome The primary endpoint of this study is:
- the rate of ongoing responses (CR and PR) according to RECIST v1.1 (Eisenhauer et al., 2009) at 24 months after first start of nivolumab/pembrolizumab.
- Secondary outcomeThe secondary endpoints include:
1a. Total duration of response after first documented CR or PR followed by treatment interruption
1b. Duration of response (CR and PR) after discontinuation of nivolumab or pembrolizumab
2. Progression-free survival (PFS) from start of nivolumab/pembrolizumab (PFS1)
3a. Rate of reintroduction of nivolumab/pembrolizumab upon first PD
3b. Failure rate of reintroducing nivolumab/pembrolizumab and the need for other salvage therapy at first PD
4. Best response on rechallenge with nivolumab/pembrolizumab
5. PFS after reintroduction of nivolumab/pembrolizumab (PFS2)
6a. Total PFS (including period after discontinuation and reintroduction of nivolumab/pembrolizumab)
6b. OS
7a. Rate of grade 3-4 adverse events (AEs) after discontinuation of nivolumab/pembrolizumab
7b. Rate of grade 3-4 adverse events (AEs) after reintroduction of nivolumab/pembrolizumab
- TimepointsSee above
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr., MD, PhD, medical oncologist A.A.M. van der Veldt
- CONTACT for SCIENTIFIC QUERIESDr., MD, PhD, medical oncologist A.A.M. van der Veldt
- Sponsor/Initiator Erasmus University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD30-sep-2018 - 7-okt-2018


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