Trial intelligence / Profile preview

Pilot Trial of Olaparib in BRCA-Mutated Melanoma

NCT05482074Phase 2

Key facts

Status: Withdrawn
Start: Oct 2022
Primary completion: May 2026
Sponsor: Dana-Farber Cancer Institute
Modality: Small Molecules

Drugs: olaparib
Conditions: melanoma

Overview

Phase 2, open-label, single-arm trial of olaparib in melanoma, sponsored by Dana-Farber Cancer Institute. Primary endpoint: Overall Response Rate at 12 weeks. Planned start Oct 2022; status: withdrawn.

Design

1 arm

Study design: Non-randomizedOpen-label

Olaparib Arm
Olaparib monotherapy

Who it enrols

Adult patients with histologically confirmed unresectable or metastatic melanoma (cutaneous, mucosal, or uveal) and a germline or somatic BRCA1/2 mutation who have progressed on prior checkpoint inhibitor therapy.

Endpoints

Primary

Overall Response Rate12 weeks

Secondary

Progression Free Survivalup to 2 years
Number of participants with treatment-related adverse eventsup to 2 years
Disease Control Rateup to 2 years
Overall Survivalup to 5 years

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