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Completed

NCT Number: NCT02574377

myDC/pDC in Stage III Melanoma Patients

This is an interventional study to test the immunogenicity of combined adjuvant myDC and pDC vaccination versus adjuvant myDC or pDC vaccination alone in stage III melanoma patients.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

About this study

Stage lll melanoma patients will receive pDC (arm A, n=10), myDC (arm B, n=10) or combined pDC/myDC (arm C, n=10). Subsequent vaccinations will be performed according to the protocol: 2 biweekly vaccinations of intranodal injections with pDC, myDC or the combination with pDC and myDC. After each vaccination the investigators will examine peripheral blood for proliferative and humoral KLH immune responses. After the vaccinations, a DTH with peptide loaded blood DC is performed from which biopsies are taken for T cell analysis. lf patients remain disease free, the investigators will repeat this cycle with a 6 months interval up to a total of three cycles. lf a tumor recurrence occurs a biopsy will be taken for laboratory evaluation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • stage III melanoma
  • WHO performance status 0-1
  • radical lymph node dissection is schedule or performed within 12 weeks prior to start of study treatment

Exclusion criteria

  • irresectable disease
  • any concurrent adjuvant therapy
  • concomitant use of oral immunosuppressive drugs
  • autoimmune diseases

Treatment and study plan

A: myDC vaccination

Drug

B: pDC vaccination

Drug

C: combined myDC/pDC vaccination

Drug

Primary outcomes

  1. immunogenicity - type I IFN

    Time frame: up to 1.5 years

    Type I IFN gene expression in PBMC shortly after vaccination. The occurrence of the type I IFN response in patients will be compared between the arms.

  2. immunogenicity - response to KLH

    Time frame: up to 1.5 years

    Proliferative, effector cytokine and humoral responses to keyhole limpet hemocyanin (KLH).The occurrence of the response will be compared between the arms.

  3. immunogenicity - T cells in DTH

    Time frame: up to 1.5 years

    Functional response and tetramer analysis of DTH infiltrating T cells against tumor peptides. The occurrence of the response will be compared between the arms.

Secondary outcomes

  1. biodistribution/localization of pDC and myDC in the lymph node

    Time frame: within 1 week after vaccination 1

    biodistribution/localization of the injected labeled pDC and/or myDC in the resected lymph node by multiple techniques

  2. safety - Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0

    Time frame: up to 1.5 years

    Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0

  3. quality of life

    Time frame: 5 years

    To assess the quality of life the EORTC QLQ-C30 questionnaire will be used.

  4. progression-free survival

    Time frame: 5 years

    time from radical lymph node dissection to recurrence of (distant) disease

  5. overall survival

    Time frame: 5 years

    time from radical lymph node dissection to death

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Myeloid and Plasmacytoid Blood Dendritic Cells for Immunotherapy of Stage III Melanoma Patients

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Oct 12, 2015
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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