Nivolumab Comparator Trial in Upper GI Cancer Completed

ClinicalTrials.gov recorded primary completion on 28 August 2026 for a completed Phase 3 study comparing domvanalimab and zimberelimab plus chemotherapy with nivolumab plus chemotherapy. The randomized, open-label trial enrolled 1,040 participants with advanced upper gastrointestinal tract adenocarcinoma.

Background

The study evaluated a first-line treatment approach for locally advanced, unresectable, or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma. The experimental regimen combined the TIGIT monoclonal antibody domvanalimab, the anti-PD-1 monoclonal antibody zimberelimab, and multiagent chemotherapy. The comparator regimen combined the anti-PD-1 monoclonal antibody nivolumab with multiagent chemotherapy.

Trial design

This was a randomized, open-label Phase 3 trial identified as NCT05568095. The registry listed the study as completed, with 1,040 participants enrolled and advanced upper gastrointestinal tract adenocarcinoma as the condition.

The study compared domvanalimab, zimberelimab, and chemotherapy against nivolumab and chemotherapy in the first-line setting. The listed chemotherapy interventions were capecitabine, fluorouracil, and leucovorin. The supplied record did not provide primary outcome entries, key measurements, or statistical analyses.

What this means

The record documents completion of a large randomized Phase 3 comparison involving nivolumab in advanced upper gastrointestinal cancers. It establishes the trial population, treatment comparison, and completion status, but does not report whether the experimental regimen improved efficacy outcomes or differed from nivolumab-based therapy in safety.

No response data, survival results, adverse-event totals, p-values, confidence intervals, or other comparative findings were supplied. Completion of the study therefore does not, by itself, establish a treatment benefit or a change to nivolumab’s use.

Source

Source: ClinicalTrials.gov, registry record for “A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body,” NCT05568095, with primary completion dated 28 August 2026. The record is available at clinicaltrials.gov/study/NCT05568095.