Melanoma Patients Immunized With Natural DenDritic Cells

Phase 3

Active, not recruiting

• Conditions: Melanoma (Skin)
• Interventions: Biological: nDC vaccination; Biological: placebo injection

• Registration Number: NCT02993315
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-15
• Primary Completion: 2024-01
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nDC vaccination arm	nDC vaccination	Patients in the nDC vaccination arm will receive a maximum of 3 cycles each consisting of 3 nDC injections intranodally (3-8x10\^6 nDC).
placebo arm	placebo injection	Patients will receive a maximum of 3 cycles each consisting of 3 placebo injections intranodally.

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival rate	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Recurrence-free survival	2 years and 5 years	Median RFS duration will be assessed by physical examination and CT of the chest and abdomen every 3-12 months, or on clinical indication, during 5 years.
Quality of Life Questionnaires	baseline, week 14, week 26, month 12, month 24, month 36, month 60
Costs (direct and indirect) of treatment	2 years
Adverse Events related to treatment	1,5 year
Overall survival	2-years and median
Tumor specific T-cell response	week 1, week 9, week 10, week 31, week 39, week 57, week 65, week 78, month 24, month 60
QALY	2 years	A cost-effectiveness acceptability curve will be derived that is able to evaluate efficiency by using different tresholds (willingness to pay) for a QALY.

Trial Locations

Locations (5)

Radboudumc; 🇳🇱 Nijmegen, Netherlands

NKI-AvL; 🇳🇱 Amsterdam, Netherlands

VUmc; 🇳🇱 Amsterdam, Netherlands

Isala klinieken; 🇳🇱 Zwolle, Netherlands

ErasmusMC; 🇳🇱 Rotterdam, Netherlands