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Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers

Gastric Cancer Clinical Trial

Official title:
Study of Induction SBRT and Olaparib Followed by Combination Pembrolizumab/Olaparib in Gastric and Gastroesophageal Junction (GEJ) Cancers

Clinical Trial Summary

This study is an open-label, phase II study with a safety lead-in to assess the response rate of induction olaparib and stereotactic beam radiotherapy (SBRT) followed by combination olaparib/pembrolizumab in patients with metastatic gastric and GEJ cancers after at least one of therapy.

Clinical Trial Description

This study is an open-label, phase II study with a safety lead-in to assess the response rate of induction olaparib and stereotactic beam radiotherapy (SBRT) followed by combination olaparib/pembrolizumab in patients with metastatic gastric and GEJ cancers after at least one of therapy. The secondary endpoint is combined therapy in tumors with evidence of both homologous recombination deficiency (by germline or somatic Next-generation DNA sequencing [NGS]), as well as homologous recombination proficiency. Exploratory endpoints will assess the impact of homologous recombination deficiency and proficiency on response to radiation, PARP inhibition and PD-1 blockade. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05379972
Study type Interventional
Source University of Colorado, Denver
Contact Kebron Elias
Phone 303-724-9839
Email kebron.elias@cuanschutz.edu
Status Recruiting
Phase Phase 2
Start date January 12, 2023
Completion date December 2028
View Details
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