Melanoma (cutaneous)
Conditions
Interventions
Discontinuation of PD-1 blockade (nivolumab or pembrolizumab) at achieving confirmed CR or PR.
Sponsors
Erasmus MC Cancer Institute
Eligibility
Inclusion criteria
Inclusion criteria: 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 o Please 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 o 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 o 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 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactAstrid A.M. van der Veldt
Erasmus MC Cancer Institute
Outcome results
None listed