Patient case: 61-year-old male with melanoma; genetic feature: BRAF amplification

Clinical trial: Adoptive Transfer of Specific Melanoma Antigens CD8+ T Cells in Metastatic Melanoma Patients: a Phase I/II Study

Summary: This study evaluates the safety as well as the potential clinical efficacy of an adoptive transfer of CD8+ T cells, sorted with HLA-peptide multimers and specific for Melan-A and MELOE-1 melanoma antigens, to patients suffering from advanced metastatic melanoma (stages IIIc and IV).


Eligibility: Inclusion Criteria:
  -  Male or female ≥ 18 and ≤ 75 years
  -  Patient expressing the A2 serotype of the human leukocyte antigen (HLA -A2 patient)
  -  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 ≤ 2 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 ≥ 2000/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")

Relevance to patient case: not relevant