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Myeloid and Plasmacytoid Blood Dendritic Cells for Immunotherapy of 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.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Start Date
September 1, 2015
Primary Completion Date
September 1, 2021
Completion Date
September 1, 2021
Last Updated
September 20, 2021
30
ACTUAL participants
A: myDC vaccination
DRUG
B: pDC vaccination
DRUG
C: combined myDC/pDC vaccination
DRUG
Lead Sponsor
Radboud University Medical Center
NCT05039801
NCT06066138
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