myDC/pDC in Stage III Melanoma Patients

Phase 1

Completed

• Conditions: Melanoma

• Registration Number: NCT02574377
• Lead Sponsor: Radboud University Medical Center

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.

Detailed 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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-12
• Status Verified: 2020-09
• Primary Completion: 2021-09
• Study Completion: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
immunogenicity - response to KLH	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.
immunogenicity - T cells in DTH	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.
immunogenicity - type I IFN	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.

Secondary Outcome Measures

Name	Time	Method
biodistribution/localization of pDC and myDC in the lymph node	within 1 week after vaccination 1	biodistribution/localization of the injected labeled pDC and/or myDC in the resected lymph node by multiple techniques
quality of life	5 years	To assess the quality of life the EORTC QLQ-C30 questionnaire will be used.
progression-free survival	5 years	time from radical lymph node dissection to recurrence of (distant) disease
overall survival	5 years	time from radical lymph node dissection to death
safety - Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0	up to 1.5 years	Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands