Spots Global Cancer Trial Database for Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers

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Trial Identification

Brief Title: Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers

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

Study ID: NCT05379972

Conditions

Gastric Cancer

GastroEsophageal Cancer

Interventions

Pembrolizumab

Olaparib

Stereotactic Body Radiation Therapy

Study Description

Brief 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.

Detailed 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.