Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients

Centre Hospitalier Universitaire Vaudois29 enrolled

Overview

The purpose of this study is to determine whether vaccination with tumor antigenic peptides and both CpG and Montanide adjuvants can induce an immune response in melanoma patients and to assess the safety of this vaccination.

Immune therapy with tumor antigenic peptides is generally quite well tolerated. However, immune activation is often only weak or even undetectable, and clinical responses (supposedly corresponding to protective immunity) are unfortunately infrequent. Further progress is required to improve the vaccines, with the goal to increase the strength of immune activation. The tumor antigenic peptides Melan-A/Mart-1 (EAA and ELA) and Tyrosinase (YMD) are combined with two drugs in this study, both of which are known to enhance immune responses: first, CpG 7909 oligodeoxynucleotides, and second, Montanide ISA-51. * Group 1: vaccination with Melan-A analog peptide + CpG and Montanide adjuvants; * Group 2: vaccination with Melan-A natural peptide + CpG and Montanide adjuvants; * Group 3 : vaccination with Melan-A natural and Tyrosinase peptides + CpG and Montanide adjuvants; * Group 4 : vaccination with Melan-A analog and Tyrosinase peptides + CpG and Montanide adjuvants.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Melanoma

Interventions

group 1BIOLOGICAL

Melan-A analog peptide + CpG + Montanide

group 2BIOLOGICAL

Melan-A natural peptide + CpG + Montanide

group 3BIOLOGICAL

Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed stage III or stage IV melanoma * Tumor expression of Melan-A +/- Tyrosinase * Human leukocyte antigen-A2 (HLA-A2) positive Exclusion Criteria: * Clinically significant heart disease * Serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders or uncontrolled peptic ulcer, or seizure or central nervous system disorders * History of immunodeficiency disease or autoimmune disease * Coagulation or bleeding disorders

Locations (1)

Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Outcomes

Primary Outcomes

Melan-A and Tyrosinase specific CD8+ T-cell reactivity will be measured by Tetramers and Elispot assays

Time frame: Change from baseline in CD8 T-cells reactivity at day 375

Safety of vaccination will be assessed according to National Cancer Institute Common Toxicity Criteria (NCI CTC) scale

Time frame: Change from baseline to day 375

Secondary Outcomes

In patients with measurable disease, tumor response will be assessed radiologically

Time frame: Change from baseline in tumor response at day 375

Data from ClinicalTrials.gov

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