Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2

Uveal Melanoma Clinical Trial

Official title: Pilot Trial of Olaparib in Patients With Unresectable or Metastatic Melanoma With Mutations in BRCA1/2 Genes

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to evaluate how effective Olaparib is when given as a treatment for primary or recurrent, unresectable or metastatic melanoma. This research study involves targeted therapy.

-The name of the study drug involved in this study is: Olaparib (also known as Lynparza)

Clinical Trial Description

A phase II, single arm, open label pilot trial in a sample size of 15 primary or recurrent, unresectable or metastatic melanoma patients that have progressed on prior checkpoint inhibitor therapy with germline or somatic mutations in BRCA1/2.

The research study procedures include screening for eligibility, study treatment including evaluations, surveys, optional biopsies, and follow up visits. This research study involves targeted therapy.

• The name of the study drug involved in this study is:

• Olaparib (also known as Lynparza)

It is expected that about 15 people will take part in this research study.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

This research study is a Pilot Study, which is the first time investigators are examining this drug for treatment of melanoma.

The U.S. Food and Drug Administration (FDA) has not approved Olaparib for this specific disease, but it has been approved for other uses.

AstraZeneca, a pharmaceutical company, is supporting this research study by providing funding for the research study and the study drug, Olaparib. ;

Related Conditions & MeSH terms

• Cutaneous Melanoma
• Melanoma
• Mucosal Melanoma
• Uveal Melanoma

• NCT number: NCT05482074
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 4, 2022
• Completion date: May 1, 2027