Clinical Trial Finder

Inclusion Criteria:

• - Male or female ≥ 18 and ≤ 75 years - Patient expressing the HLA-A*0201 subtype of the human leukocyte antigen (HLA -A2) - Patient with metastatic melanoma stage IIIc or IV (AJCC 2010) except brain metastases - Tumor expressing the antigens Melan-A and MELOE-1 detected by RT-PCR - Absence of cerebral metastases - ECOG ≤ 1 or Karnofsky ≥ 80% - Prior adjuvant melanoma treatment (before metastatic stage) authorized (anti- BRAF, anti-CTLA4, IFN, TIL.

.. )

• - Disease measurable / evaluable within 28 days before the first administration of study treatment - Negative viral serology (HIV 1/2, Ag p24 , HTLV 1/2 , hepatitis B and C, syphilis) - Results of analysis: - Hemoglobin ≥ 10 g / dl or ≥ 6.25 mmol / l - Leukocytes ≥ 4000/μl - Lymphocytes ≥ 1500/μl - Platelets ≥ 80.000/μl - Creatinine ≤ 2.5 N - Total bilirubin ≤ 3 N - AST and ALT ≤ 3 N without liver metastases; ≤ 5 N with liver metastases - Negative pregnancy test for women of childbearing age - Patient affiliated to a social security system - Patient who has signed informed consent

  Exclusion Criteria:

  - Brain metastases - Ocular primitive melanoma - Treatment of metastatic melanoma by more than two lines (chemotherapy , immunotherapy, targeted therapy or radiotherapy) or within 4 weeks before the inclusion - Treatment with ipilimumab within 8 weeks before the inclusion - Known allergy to albumin - Contraindication to the use of vasopressors - Positive viral serology for HIV 1/2 , Ag p24 , HTLV 1/2, hepatitis B or C, or syphilis - Women who are pregnant, nursing or refusing to use contraceptives, women with no negative pregnancy test at baseline - Presence of a second active cancer (with the exception of cervical cancer in situ or skin cancer other than melanoma) - History of event or current event of a progressive or non-stabilized severe heart disease (congestive heart failure, coronary artery disease, uncontrolled hypertension, serious arrhythmias or ECG signs of previous myocardial infarction) - Uncontrolled thyroid dysfunction - Any serious acute or chronic illness (active infection requiring antibiotics, bleeding disorders or other condition requiring concomitant treatment not allowed in this study) - History of chronic autoimmune disease (Addison's disease, multiple sclerosis, Graves' disease, rheumatoid arthritis, systemic lupus erythematosus, .

.. ) with the exception of patients with active vitiligo or a history of vitiligo - History of uveitis and retinopathy associated with melanoma - Adults under a legal protection regime (guardianship, trusteeship, "sauvegarde de justice")

Arms

Experimental: Autologous somatic cell therapy

Patients treated with melanoma antigens-specific CD8+ T lymphocytes followed by subcutaneous injections of Proleukin.

Interventions

Biological: - Melanoma antigens-specific CD8+ T lymphocytes

The intervention uses an autologous somatic cell therapy medicinal product. It consists in the intravenous injection of melanoma antigens (Melan-A and MELOE-1) - specific CD8+ T lymphocytes followed by subcutaneous injections of Proleukin.