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NOT YET RECRUITING
NCT07807878
PHASE2

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

Sponsor: Assistance Publique Hopitaux De Marseille

View on ClinicalTrials.gov

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.

Official title: Phase II Trial of Temozolomide in BAP1 Mutated Patients With Advanced or Metastatic Cutaneous Melanoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2027-06-01

Completion Date

2031-06-01

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

DRUG

Temozolomide (TMZ)

Patients will be treated at a dose of 200mg/m2 from day 1 to day 5, every 28 days, for up to two years