myDC/pDC in Stage III Melanoma Patients

NCT ID: NCT02574377

Last Updated: 2021-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A: myDC vaccination

intranodal injection with tumor peptide-loaded myeloid dendritic cells

Group Type EXPERIMENTAL

A: myDC vaccination

Intervention Type DRUG

B: pDC vaccination

intranodal injection with tumor peptide-loaded plasmacytoid dendritic cells

Group Type EXPERIMENTAL

B: pDC vaccination

Intervention Type DRUG

C: combined myDC/pDC vaccination

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

Group Type EXPERIMENTAL

C: combined myDC/pDC vaccination

Intervention Type DRUG

Interventions

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A: myDC vaccination

Intervention Type DRUG

B: pDC vaccination

Intervention Type DRUG

C: combined myDC/pDC vaccination

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Winald Gerritsen

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL49528.000.14

Identifier Type: -

Identifier Source: org_study_id

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