Safe Stop Onderzoek: het eerder staken van nivolumab of pembrolizumab bij patiënten met gevorderd melanoom die goed reageren op deze behandeling
- Conditions
- Melanoma (cutaneous)
- Registration Number
- NL-OMON21032
- Lead Sponsor
- Erasmus MC Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
For final inclusion in the trial, patients need to have a confirmed CR/PR according to RECIST v1.1 using a diagnostic CT, including a diagnostic CT at baseline
A potential subject who meets the following criteria can be screened for inclusion in this study:
-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
oPlease note: if one of the PD-1 blockade treatments is replaced by the other because of a reason other than progression or non-response, e.g. because of infusion-related reactions, this is still considered first-line therapy and patients are still eligible for inclusion
-documented target lesion(s) according to RECIST v1.1 on diagnostic CT at start of PD-1 blockade with nivolumab or pembrolizumab
oFor 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
oFor 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 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)
-planned and willing to discontinue nivolumab or pembrolizumab within 6(+1) weeks after first confirmation of CR or PR before the full period of 2 years therapy
-signed and dated informed consent form
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 The primary endpoint of this study is the rate of ongoing response according to RECIST v1.1 at 24-months (from first start of treatment with PD-1 blockade).
- Secondary Outcome Measures
Name Time Method The secondary endpoints include best overall response, duration of response after discontinuation of PD-1 blockade, the need and outcome of rechallenge with PD-1 blockade, and changes in SAE(s). After discontinuation of PD-1 blockade, changes in HRQoL (FACT-M, EuroQol EQ-5D, CWS) will be measured at different time points and compared with patients without early discontinuation of PD-1 blockade. In addition, measurements will be performed to determine the impact of treatment discontinuation on healthcare resource use, productivity losses (RUQ-M by iMTA), and hours of informal care.