Results from a Phase 2 trial (NCT04021108) investigating nivolumab in metastatic or unresectable gastroesophageal cancers were posted on 2026-06-24. The study reported a 1-year overall survival rate of 72.77% for the nivolumab-alone cohort, compared to 64.71% for the nivolumab plus radiation cohort.
Background
Nivolumab is an immunotherapy drug. This trial explored its use in the first-line treatment of metastatic or unresectable gastroesophageal cancers.
Trial design
This was a randomized Phase 2 study (NCT04021108) with an enrollment of 80 participants, currently active but not recruiting. The study focused on subjects with Gastroesophageal Adenocarcinoma who did not experience disease progression after initial therapy with FOLFOX and nivolumab. Participants were randomized to receive either nivolumab alone (240 mg) (Cohort 1) or nivolumab (240 mg) plus radiation (Cohort 2). The trial's primary outcomes were not listed in the results data.
Key results
The trial reported key measurements for both cohorts:
- For 12-month Progression Free Survival, 9 participants were observed in Cohort 1 and 4 participants in Cohort 2, totaling 13 participants across all randomized subjects.
- Amongst all randomized subjects, the 1-year Overall Survival rate was 72.77% for Cohort 1 and 64.71% for Cohort 2.
- The occurrence of Grade 3 and Grade 4 adverse events attributable to immunotherapy was 21.21% in Cohort 1 and 26.47% in Cohort 2.
What this means
The posted results provide insights into the efficacy and safety profiles of nivolumab as a monotherapy versus in combination with radiation for a specific population of metastatic or unresectable gastroesophageal cancer patients. The observed 1-year overall survival rate was numerically higher in the nivolumab-alone cohort compared to the nivolumab plus radiation cohort. Additionally, the rate of significant Grade 3 and Grade 4 adverse events was lower in the nivolumab-alone arm. These findings contribute to the understanding of nivolumab's potential in this setting, particularly regarding the impact of adding radiation therapy.
Source
The trial results were posted on 2026-06-24 on ClinicalTrials.gov, an official database of clinical studies. The full details are available on clinicaltrials.gov under the identifier NCT04021108.