BAP1, or BRCA1-associated protein 1, is a gene involved in DNA repair via homologous recombination and is considered a tumor suppressor gene. It is lost or inactivated in a large number of tumors, and the presence of germline BAP1 mutations is associated with a syndrome of tumor predisposition.
Following our team's observation of two exceptional responses to temozolomide in patients who had reached a therapeutic impasse-one of which lasted 11 months and involved both intracerebral and extracerebral tumors-we hypothesize that this mutation may lead to increased susceptibility to chemotherapy.
Adult patient (≥18 years old)
Patients who have received information about the study and have signed an informed consent form.
Histopathological confirmation of a diagnosis of stage III (unresectable) or stage IV (metastatic) cutaneous melanoma according to the 8th edition of the AJCC staging system.
Patient has experienced treatment failure after undergoing at least one line of Immunotherapy with at least one immune checkpoint inhibitor (anti-PD1, anti-PD1+anti-CTLA4, or anti-PD1+anti-LAG3) and one line of targeted therapy combining BRAF and MEK inhibitors, if indicated.
Patients with non-cutaneous melanoma, whether uveal, mucosal, of unknown primary origin or leptomeningeal
Patients who have received a minimum of one line of chemotherapy for melanoma treatment
Positive serology results for human immunodeficiency virus (HIV), active hepatitis B or C infection (acute or chronic) or uncontrolled infection
Concomitant presence or history of another malignancy, except for the following: appropriately treated squamous or basal cell carcinoma of the skin (adequate healing is required prior to study entry); any other solid tumor, curatively treated and without evidence of recurrence for at least 2 years prior to study entry.
Single group
Temozolomide (TMZ)
DrugPatients will be treated at a dose of 200mg/m2 from day 1 to day 5, every 28 days, for up to two years
Overall response rate at day 84
Overall response rate will be defined as the percentage of patients with a partial response or a complete response according to RECIST 1.1 criteria.
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