The aim of this study is to determine whether adjuvant treatment with nDC vaccination, after complete radical lymph node dissection or sentinel node procedure in stage IIIB and IIIC melanoma patients, improves recurrence-free survival (RFS) as compared to treatment with matching placebo.
This is a phase 3, randomized, double-blind, interventional study of nDC vaccination versus placebo. Dendritic cell-based immunotherapy consists of antigen-loaded autologous DC that are administered to patients with the intention of inducing antigen-specific T and B cell responses and proved safe with minimal side effects. Natural DC (nDC) consist of plasmacytoid DC and myeloid DC. Subjects will be randomized 2:1 and stratified by stage of disease, adjuvant radiotherapy, BRAF mutation status, HLA-type and nDC production centre. The treatment will be continued for a maximum of 1.5 years or until recurrence of disease, unacceptable toxicity or withdrawal from the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
148
NKI-AvL
Amsterdam, Netherlands
VUmc
Amsterdam, Netherlands
Radboudumc
Nijmegen, Netherlands
ErasmusMC
Rotterdam, Netherlands
Isala klinieken
Zwolle, Netherlands
Recurrence-free survival rate
The primary objective of this study is to determine whether adjuvant nDC vaccination, after complete radical lymph node dissection or sentinel node procedure in stage IIIB and IIIC melanoma patients, improves 2-year RFS rate as compared to treatment with matching placebo. Defined as the percentage of patients who are alive and without recurrence of melanoma 2 years after randomization.
Time frame: 2 years
Treatment of melanoma patients
Adjuvant treatment with nDC vaccination or placebo, after standard treatment
Time frame: The primary endpoint, 2-year RFS. At data cutoff, the median duration of follow-up was 56.3 months.
Overall survival
Overall survival
Time frame: 2-years and median
Tumor specific T-cell response
Tumor specific T-cell response
Time frame: week 1, week 9, week 10, week 31, week 39, week 57, week 65, week 78, month 24, month 60
Quality of Life Questionnaires
Quality of Life Questionnaires
Time frame: baseline, week 14, week 26, month 12, month 24, month 36, month 60
Costs (direct and indirect) of treatment
Costs (direct and indirect) of treatment
Time frame: 2 years
QALY
A cost-effectiveness acceptability curve will be derived that is able to evaluate efficiency by using different tresholds (willingness to pay) for a QALY.
Time frame: 2 years
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Adverse Events related to treatment
Adverse Events related to treatment
Time frame: 1,5 year