Trial results for the Phase 2 study (NCT05379972) investigating pembrolizumab in combination with olaparib for patients with metastatic gastric and gastroesophageal junction (GEJ) cancers were posted on ClinicalTrials.gov on 2026-05-04. The study reported 0 objective responses in unirradiated tumors across all cohorts, including HR deficient, HR proficient, and the overall cohort.

Background

The study, titled "Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers," aimed to evaluate the response rate of this combination therapy in patients with metastatic gastric and GEJ cancers who had received at least one prior line of therapy.

Trial design

The study (NCT05379972) was an open-label, Phase 2 trial with a safety lead-in. It enrolled 9 participants diagnosed with metastatic gastric cancer or gastroesophageal junction (GEJ) cancer. The intervention involved induction olaparib and stereotactic beam radiotherapy (SBRT), followed by combination olaparib and pembrolizumab. The trial's primary focus included assessing the objective response rate of unirradiated tumors.

Key results

For the outcome of "Objective Response Rate (ORR) of Unirradiated Tumors," the trial reported the following results:

What this means

The reported results indicate that the combination of olaparib and pembrolizumab, following induction with olaparib and SBRT, did not lead to objective responses in unirradiated tumors in this small Phase 2 study population of patients with metastatic gastric and GEJ cancers. These findings suggest that this specific treatment regimen, as evaluated in this trial, did not demonstrate clinical activity in terms of objective tumor response.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05379972, titled "Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers," were posted on 2026-05-04 on clinicaltrials.gov.