myDC/pDC in Stage III Melanoma Patients

NCT02574377 | Completed Phase 1

• 1 other identifier: NL49528.000.14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (3)

• immunogenicity - type I IFN

  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.

  up to 1.5 years

• immunogenicity - response to KLH

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

  up to 1.5 years

• immunogenicity - T cells in DTH

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

  up to 1.5 years

Secondary Outcomes (5)

• biodistribution/localization of pDC and myDC in the lymph node

  within 1 week after vaccination 1

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

  up to 1.5 years

• quality of life

  5 years

• progression-free survival

  5 years

• overall survival

  5 years

Study Arms (3)

A: myDC vaccination

EXPERIMENTAL

intranodal injection with tumor peptide-loaded myeloid dendritic cells

Drug: A: myDC vaccination

B: pDC vaccination

EXPERIMENTAL

intranodal injection with tumor peptide-loaded plasmacytoid dendritic cells

Drug: B: pDC vaccination

C: combined myDC/pDC vaccination

EXPERIMENTAL

intranodal injection with tumor peptide-loaded myeloid and plasmacytoid dendritic cells

Drug: C: combined myDC/pDC vaccination

Interventions

A: myDC vaccination DRUG

A: myDC vaccination

B: pDC vaccination DRUG

B: pDC vaccination

C: combined myDC/pDC vaccination DRUG

C: combined myDC/pDC vaccination

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Winald Gerritsen

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 12, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 20, 2021

Record last verified: 2020-09

Locations

NL (1)