Trial intelligence / Profile preview

Temozolomide in BAP1 Mutated Advanced Cutaneous Melanoma

NCT07807878Phase 2

Key facts

Status
Not yet recruiting
Start
Jun 2027
Primary completion
Jan 2030
Sponsor
Assistance Publique-Hôpitaux de Marseille
Conditions
cutaneous melanoma (CM)
01

Overview

Phase 2, open-label, single-arm trial of temozolomide in cutaneous melanoma (CM), sponsored by Assistance Publique-Hôpitaux de Marseille. Primary endpoint: Overall Response Rate at 84 days. Planned start Jun 2027; status: not yet recruiting.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • patients with advanced cutaneous melanoma with a BAP1 mutation

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

03

Who it enrols

Adult patients with unresectable stage III or metastatic stage IV cutaneous melanoma harboring a pathogenic BAP1 mutation, who have progressed on prior immunotherapy and targeted therapy (if indicated), with ECOG <= 3 and adequate organ function. Excludes patients with prior chemotherapy for melanoma, non-cutaneous melanoma, or active infections.

04

Endpoints

Primary

  • Overall Response Rate

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