Patients with histologically confirmed metastatic melanoma
Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma (grade ≤ 1).
At least one measurable brain metastasis between 5 mm and 35 mm in diameter, not previously treated with surgery and/or radiosurgery and located less than 5 cm from the skull
Patients may have received -or not- prior radiosurgery and/or surgery for brain metastases; if they have received prior local treatment, they must have at least 1new RANO and RECIST assessable brain metastases.
BRAF status wild type or mutated (and in that case previous treatment with BRAF inhibitor and MEK inhibitor allowed)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
Age \>18 year
Hemoglobin ≥10g/dl
Platelets ≥ 100000mm3
Neutrophils ≥1500/mm3
Creatinine Clearance ≥ 50ml/mn
AST \<3N
ALT\<3N
Total bilirubin \<1.5N
Alkaline phosphatase \<3N
INR \< 1.5
Prothrombin ≥70%
TCA \<1.2
No Hepatocellular insufficiency
No unhealed wound on the head
No allergy to poly isoprene
Signed informed consent
Patient with health insurance coverage
Life expectancy \> 3 months
You may not be if
Patient previously treated by antiPD1 (except adjuvant antiPD1 therapy)
Ocular melanoma
Symptomatic or diffuse leptomeningeal involvement.
Symptomatic hemorrhagic brain metastases.
Symptoms of incoercible intracranial pressure; patients receiving corticosteroids and patients presenting intermittent seizures can be enrolled if they have a stable dose of corticosteroids (≤ 30mg/day corticotherapy) and anti-epileptic treatment since at least 2 weeks before enrolment.
Indication for urgent neurosurgery or radiotherapy
Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured or stage I untreated Chronic Lymphoid Leukemia.
Known human immunodeficiency viruses (HIV) infection and any ongoing infectious disease or significant background.
Concurrent administration of any anticancer therapies other than those administered in this study.
Treatment with any cytotoxic and/or investigational drug, antiCTLA4 or targeted therapy ≤ 4 weeks or \<5 half lives for targeted therapies or chemotherapy, prior to day 1 of study.
