drugset / Trial / NCT07807878

Trial of Temozolomide in BAP1 Mutated Patients With Advanced or Metastatic Cutaneous Melanoma

NCT07807878 ↗

Phase 2 Not yet recruiting 28 enrolled Assistance Publique Hopitaux De Marseille
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2027-06-01
Primary completion
2030-01-01
Completion
2031-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 200 mg/m2 —

Indications