drugset / Trial / NCT04633902

Phase II Study of Olaparib and Pembrolizumab in Advanced Melanoma With Homologous Recombination (HR) Mutation

NCT04633902 ↗

NaSingle-groupOpen-labelTreatment

Summary

This open-label phase II trial studies how well olaparib in combination with pembrolizumab works in treating patients with advanced, metastatic melanoma with the homologous recombination (HR) pathway gene mutation / alteration. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and potentially augment an anti-tumor immune response to pembrolizumab. The trial is designed to assess the efficacy and safety of olaparib in combination with pembrolizumab in patients with HR mutation/ alteration whose disease progressed on prior immunotherapy and/or BRAF-targeting therapy

Timeline

Start
2021-03-03
Primary completion
2023-06-30
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Olaparib Small molecule 300 mg —
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications