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

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- 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.

Type of Study



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

Principal Investigator
Photograph of Sunnie Kim,  MD

Sunnie Kim, MD

Study ID

Protocol Number: 21-4129

More information available at ClinicalTrials.gov: NCT05379972


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