myDC/pDC in Stage III Melanoma Patients

Radboud University Medical Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: Melanoma

Treatments: Drug: C: combined myDC/pDC vaccination; Drug: A: myDC vaccination; Drug: B: pDC vaccination

Study type: Interventional

Funder types: Other

Identifiers

NCT02574377

NL49528.000.14

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

A: myDC vaccination

Experimental group

Description:

intranodal injection with tumor peptide-loaded myeloid dendritic cells

Treatment:

Drug: A: myDC vaccination

B: pDC vaccination

Experimental group

Description:

intranodal injection with tumor peptide-loaded plasmacytoid dendritic cells

Treatment:

Drug: B: pDC vaccination

C: combined myDC/pDC vaccination

Experimental group

Description:

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

Treatment:

Drug: C: combined myDC/pDC vaccination