- *And when clinically indicated. #According to national/institute’s standards. 1Follow-up assessments according to local protocol/standard of care. Every 12 weeks (unless stated other) for up to two years after adjuvant treatment, year 3, 4, 5 according to institute’s standard. 2Clinical photographs will be taken of all cutaneous lesions, noting in detail the exact size and location of any (skin) lesions that exist. 3Hematology and chemistry. At screening, PT/INR, aPTT and serology (HIV, HbsAG, anti-HCV, HSV, anti-CMV) are also determined. 4Every 12 weeks during follow-up. 5T-VEC seroconversion dose 106 PFU/mL. 6T-VEC dose 108 PFU/mL. 7AEs will be graded according to CTCAE v5.0 from moment of signing informed consent. New occurring AEs and any SAEs will reported up to 100 days post last treatment. 8Only registration of medication that is used for treatment of immune-related AEs from moment of signing informed consent. 9Toxicity from prior treatment will be evaluated. 10100 ml heparinized blood (for PBMC). 11Only at week 3 prior to first nivolumab. 12At relapse. 1320 ml EDTA blood (for isolation of plasma for ctDNA). 14Three biopsies taken with a 14G needle of thru-cut and will be stored as fresh frozen and formalin-fixed paraffin-embedded material for translational research purposes. At baseline pathological confirmation of melanoma will be performed. 15If possible, surgical material should be preserved as fresh frozen and formalin-fixed paraffin-embedded material
- AE adverse event; aPTT activated partial thromboplastin time; CMV Cytomegalovirus; CT computed tomography; CTCAE Common Terminology Criteria for Adverse Events; ECG electrocardiogram; EDTA Ethylenediaminetetraacetic acid; HbsAG hepatitis B virus surface antigen; HCG human chorionic gonadotropin; HCV hepatitis C virus; HIV human immunodeficiency virus; HSV herpes simplex virus; INR International normalization ratio; MRI magnetic resonance imaging; PBMC peripheral blood mononuclear cells; PET Positron Emission Tomography; PFU plaque-forming units; PTT partial thromboplastin time; SAE Serious Adverse Event; WOCBP women of childbearing potential
