A Phase II study of induction SBRT and olaparib followed by combination pembrolizumab/olaparib in gastric and gastroesophageal junction (GEJ) cancers

Primary Objective

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.

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Description

PRIMARY: To assess the anti-tumor efficacy of combined therapy as determined by measurement of objective response rate (ORR) SECONDARY: To assess the anti-tumor efficacy of combined therapy as determined by measurement of overall survival (OS), progression free survival (PFS), duration of response (DOR) and disease control rate (DCR) as a total cohort and HRD versus HR proficient. To evaluate the safety and tolerability of radiotherapy added to Olaparib.

Details
Age
Adult
Eligibility
- Histologically confirmed metastatic gastric or GEJ adenocarcinoma that is amenable to biopsy either at primary or metastatic site. - Patient must consent at initiation of study to serial tumor biopsies during study. Irradiated lesions will not be considered for biopsy. For baseline biopsy, available archived tumor tissue of a metastatic tumor collected up to 28 days prior to registration is acceptable. If, after patient consent, the tumor is deemed inaccessible, the biopsy is not in the subject’s best interest per investigator discretion, or the patient refuses biopsy during course of the study, patients will be allowed to remain on study. - Participant must have at least one radiographically-confirmed index lesion that will not undergo RT and is measurable based on RECIST v1.1. - Participants must have received at least one line of therapy including a fluoropyrimidine and platinum drug. For participants with HER2+ tumors, they must have received trastuzumab. Adjuvant therapy does not count toward first-line therapy unless patient recurs within 6 months of completion. - Patients are excluded if they have known active CNS metastases and/or carcinomatous meningitis that requires ongoing treatment or are found to be progressing.Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Locations

Highlands Ranch Hospital
Memorial Hospital Central
Memorial Hospital North
University of Colorado Hospital

Principal Investigator
Photograph of Sunnie Kim

Sunnie Kim

Study ID

Protocol Number: 21-4129

More information available at ClinicalTrials.gov: NCT05379972

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