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Phase I/II Study of Peptide Vaccination Associated With Tumoral Immunomodulation With Proinflammatory Cytokines and Imiquimod in Patients With Advanced Metastatic Melanoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Metastatic Melanoma

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Trial Information

Phase I/II Study of Peptide Vaccination Associated With Tumoral Immunomodulation With Proinflammatory Cytokines and Imiquimod in Patients With Advanced Metastatic Melanoma

Patients will receive the following treatments:

1. Vaccinations:

The vaccine will be the MAGE-3.A1 and/or the NA17.A2 peptide, matching the patient's
HLA type and the gene expression of his tumor. If both antigens are expressed, then the
patient will receive both peptides.

2. Local treatment with a combination of immunomodulatory drugs:

This treatment will combine peritumoral injection of IL-2, IFN-α and GM-CSF (6000 IU,
100.000 IU and 300 ng per tumor injected, respectively), as well as topical application of
imiquimod (applied during 24h). The peritumoral injections of cytokines will be given on
days +2,+3,+4,+7,+8 and +9, and the Aldara® cream will be applied on days +2 and +7
following vaccines 3 and 4. One or 2 cutaneous lesions will be treated, if there are 2 or
more such lesions present at day 29 of the treatment, respectively.

Inclusion Criteria:

- 1. Patients with histologically proven cutaneous melanoma at one of the following
AJCC stages.Regional metastatic disease (any T; N2c or N3; M0). Distant metastatic
disease (any T; any N; M1a, M1b or M1c*).*except uncontrolled brain metastasis.

- 2. HLA-A1 or HLA-A2 (by serology or molecular biology).

- 3. MAGE-3 gene expression by the tumor if patient is HLA-A1 and/or NA17 gene
expression by the tumor if patient is HLA-A2 (determined by RT-PCR analysis).

- 4. Measurable Disease (RECIST v1.1)Patients must have at least 2 cutaneous
metastases, suitable for peri-tumoral injection and surgical resection, with their
largest diameter equal to or greater than 5 mm.

- 5. Age ≥ 18 years.

- 6. Karnosky Performance status (KPS) ≥70 or WHO performance status of 0 or 1

- 7. Expected survival of at least 6 months.

- 8. Normal laboratory values : Platelet count ≥100x103/μL,Leucocyte count ≥ 3x103/μL,
Hemoglobin ≥ 9 g/dL, ASAT and ALAT ≤ 2xUNL, Serum creatinine ≤1.5xUNL, Total
bilirubin ≤ 1.5xUNL, LDH ≤ 1.5xUNL

- 9. Viral serology : negative antibodies for HCV & HIV; negative antigens for HBV.

- 10. Patient should agree to perform biopsies and blood collections for translational

- 11. Signed informed consent from the patient or legal representative must be

Exclusion Criteria:

1. Uncontrolled brain or central nervous system metastases.

2. Previous treatment for the melanoma within 6 weeks from inclusion, with any reagent
known to modulate the immune system such as a cancer vaccine, interferon-alpha,
interleukins or anti-CTLA-4 antibodies.

3. Previous chemotherapy, radiotherapy, corticotherapy, or other immune suppressive
therapy within 4 weeks from inclusion.

4. Clinically significant cardiovascular disease (including cardiac insufficiency NYHA
grade III and IV, unstable angina, arrythmia, myocardial infarction, symptomatic
congestive heart failure) in the past 12 months before enrollment.

5. Other serious acute or chronic illnesses, e.g. active infections requiring
antibiotics, bleeding disorders or other conditions requiring concurrent medications
not allowed during this study.

6. Other malignancy within 3 years prior to entry in the study, except for treated
non-melanoma skin cancer and in situ cervical carcinoma.

7. Active immunodeficiency disease or autoimmune disease (Vitiligo is not an exclusion

8. Lack of availability for immunological and clinical follow-up assessments.

9. Participation in any other clinical trial involving another investigational agent
within 4 weeks prior to enrollment.

10. Subject pregnant or breastfeeding, or planning to become pregnant within 6 months
after the end of treatment.

11. Subject (male or female) not willing to use highly effective methods of contraception
(per institutional standard) during treatment and for 6 months after the end of

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine whether peptide vaccination associated with local peritumoral treatment with a combination of interleukin-2, interferon-alpha, granulocyte-macrophage colony stimulating factor, and imiquimod, induces tumor responses.

Outcome Description:

Tumor response will be assessed in accordance with the Modified RECIST version 1.1

Outcome Time Frame:

week 11 day 71

Safety Issue:


Principal Investigator

Baurain Jean-Francois, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cliniques universitaires Saint-Luc


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

Luc 10-002



Start Date:

August 2010

Completion Date:

August 2012

Related Keywords:

  • Metastatic Melanoma
  • Melanoma