Nivolumab Phase 3 Trial for Advanced Gastric Cancer Reaches Primary Completion

The Phase 3 trial (NCT05111626) investigating nivolumab in combination with bemarituzumab and chemotherapy for advanced FGFR2b overexpressed untreated gastric and gastroesophageal junction cancer reached its primary completion on 2025-10-14. This significant milestone indicates that data collection for the primary endpoint has concluded for the study, which enrolled 515 participants.

Background

The trial focuses on untreated advanced gastric cancer and gastroesophageal junction adenocarcinoma characterized by FGFR2b overexpression. The study involves nivolumab, bemarituzumab, and chemotherapy as interventions, aiming to evaluate their combined effect in this specific patient population.

Trial design

The study, identified as NCT05111626, is a Phase 3, randomized clinical trial that enrolled 515 participants. It investigates treatments for gastric cancer and gastroesophageal junction adenocarcinoma. The trial's design includes two parts: Part 1 evaluates the safety and tolerability of bemarituzumab plus chemotherapy (mFOLFOX6) and nivolumab. Part 2's main objective is to compare the efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab, with overall survival as a key assessment.

What this means

The primary completion of this Phase 3 trial represents a critical step in the evaluation of nivolumab in combination with bemarituzumab and chemotherapy for advanced FGFR2b overexpressed gastric and gastroesophageal junction cancer. This milestone signifies that all necessary data for the primary endpoint have been collected, moving the study closer to analysis and the potential reporting of findings. The results from this trial will be important for understanding potential new therapeutic strategies for patients with these challenging conditions.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The event for study NCT05111626 was recorded on 2025-10-14 on clinicaltrials.gov.