Melanoma Patients Immunized with Natural DenDritic Cells

NCT ID: NCT02993315

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2024-05-31

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.

Conditions

Melanoma (Skin)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

nDC vaccination arm

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

Group Type: EXPERIMENTAL

nDC vaccination

Intervention Type: BIOLOGICAL

placebo arm

Patients will receive a maximum of 3 cycles each consisting of 3 placebo injections intranodally.

Group Type: PLACEBO_COMPARATOR

placebo injection

Intervention Type: BIOLOGICAL

Interventions

nDC vaccination

Intervention Type: BIOLOGICAL

placebo injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• No clinical evidence for brain metastasis. If brain metastases are clinically suspected, a CT or Magnetic Resonance Imaging (MRI) scan of the brain must exclude brain metastases.
• World Health Organization (WHO) performance status of 0 or 1 at time of randomization.
• Adequate hematologic, renal and liver function as defined by laboratory values performed within 4 weeks of randomization.
• No second malignancy in the previous 5 years, with the exception of adequately treated carcinoma in-situ and basal or squamous cell carcinoma of the skin.
• No concomitant use of immunosuppressive drugs orally or intravenously. Topical and intranasal steroids are permitted.
• No uncontrolled infectious disease, i.e. negative testing for HIV, HBV, HCV and syphilis.
• No autoimmune disease such as, but not limited to, inflammatory bowel disease, multiple sclerosis, and lupus. Patients with type 1 diabetes mellitus, hypothyroidism after autoimmune thyroiditis and skin disorders are not excluded.
• No serious (bleeding and clotting) condition that may interfere with safe leukapheresis.
• No pregnant or lactating women.
• No Women Of Child-Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 8 weeks after the last administration of the treatment. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea > 12 consecutive months].
• Patients must have absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions must be discussed with the patient before registration in the trial.
• Expected adequacy of follow-up.
• Written informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch National Health Care Institute

OTHER

Sponsor Role: collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jolanda de Vries, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

NKI-AvL

Amsterdam, , Netherlands

VUmc

Amsterdam, , Netherlands

Radboudumc

Nijmegen, , Netherlands

ErasmusMC

Rotterdam, , Netherlands

Isala klinieken

Zwolle, , Netherlands

Countries

Netherlands

Other Identifiers

NL55823.000.15

Identifier Type: -

Identifier Source: org_study_id