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

Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients With CpG7909, Tumor Antigenic Peptides and Montanide

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00112229

Enrollment

Registered

2005-06-01

Start date

2003-04-30

Completion date

2012-06-30

Last updated

2013-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

Immunotherapy, Vaccination, Melanoma, Melan-A/Mart-1 peptide, Tyrosinase peptide, CpG, Montanide

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALgroup 1

Melan-A analog peptide + CpG + Montanide

BIOLOGICALgroup 2

Melan-A natural peptide + CpG + Montanide

BIOLOGICALgroup 3

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

BIOLOGICALgroup 4

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Melan-A and Tyrosinase specific CD8+ T-cell reactivity will be measured by Tetramers and Elispot assays	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	Change from baseline to day 375

Secondary

Measure	Time frame
In patients with measurable disease, tumor response will be assessed radiologically	Change from baseline in tumor response at day 375

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026