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Upfront Maintenance Olaparib in Advanced Ovarian Cancer BRCAwt Patients With Known Homologous Recombination Deficiency

Ovarian Cancer Clinical Trial

Official title:
A Non-randomized Prospective Phase II Study of Upfront Maintenance Olaparib in Advanced Ovarian Cancer BRCAwt Patients With Known Homologous Recombination Deficiency

Clinical Trial Summary

This is a prospective non-randomized efficacy trial of olaparib maintenance therapy after frontline treatment with platinum-based therapy in advanced ovarian cancer patients with BRCAwt, homologous recombination deficient (HRD) disease.

Clinical Trial Description

The use of PARP inhibitors has revolutionized how we think of the BRCA mutated population of ovarian cancer patients. However, this population with BRCA mutation is not the only one with homologous recombination deficiencies (HRD). Examples of BRCAwt but HR deficient mutations (HRD) include: BRIP1, RAD51C/D, and CHEK2 as well as epigenetic changes like BRCA methylation. This study is designed to provide information on if BRCAwt, HRD patients with advanced ovarian cancer benefit from maintenance olaparib monotherapy after frontline treatment. PAOLA-1 showed that this population had improved PFS from the addition of olaparib to bevacizumab but there is currently no information on how this population does with olaparib alone. For this reason, a similar population to PAOLA-1 will be used in this study. This study is designed to fill an important gap in the data provided by PAOLA-1. It is now considered standard of care for patients with BRCAwt, HRD disease to receive maintenance PARPi either alone (e.g. niraparib) based of PRIMA or in combination with bevacizumab based of PAOLA-1. Therefore, there is little to no concern that patients will be missing out on potentially beneficial therapy that could impact their prognosis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06120972
Study type Interventional
Source University of Pittsburgh
Contact Kelsey Mitch, RN
Phone 412-623-6793
Email adamkka2@upmc.edu
Status Recruiting
Phase Phase 2
Start date January 17, 2024
Completion date December 31, 2029
View Details
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