Trial results for a Phase 3 study evaluating the regorafenib and nivolumab combination (RegoNivo) in refractory advanced gastro-oesophageal cancer were posted on ClinicalTrials.gov on 2026-06-10. The RegoNivo arm showed a median overall survival (OS) of 5.91 months compared to 6.28 months for standard of care chemotherapy. The combination did not significantly improve OS (HR 0.88, 95% CI 0.71-1.09, p=0.23), but demonstrated a higher objective tumor response rate (OTRR).
Background
The study investigated the combination of regorafenib and nivolumab (RegoNivo) for participants with refractory advanced gastro-oesophageal cancer. This Phase 3 trial aimed to assess whether RegoNivo could improve overall survival compared to existing standard chemotherapy options in this patient population.
Trial design
The completed Phase 3 study (NCT04879368) enrolled 462 participants with gastro-oesophageal cancer. The trial compared the efficacy of the regorafenib and nivolumab combination (RegoNivo) against standard of care chemotherapy, which included docetaxel, paclitaxel, or irinotecan. The primary objective was to determine if RegoNivo improved overall survival in this refractory patient group.
Key results
Results from the trial showed the following:
- Overall Survival (OS): Median OS for the RegoNivo arm was 5.91 months, compared to 6.28 months for the Standard of Care arm. The Hazard Ratio (HR) for OS was 0.88 (95% Confidence Interval: 0.71 to 1.09), with a p-value of 0.23.
- Progression-Free Survival (PFS): Median PFS was 1.91 months for RegoNivo and 1.87 months for Standard of Care. The HR for PFS was 0.85 (95% Confidence Interval: 0.69 to 1.05).
- Objective Tumor Response Rate (OTRR): 23 participants in the RegoNivo arm achieved a complete or partial response, versus 4 participants in the Standard of Care arm. The Odds Ratio (OR) for OTRR was 2.99 (95% Confidence Interval: 1.0 to 12.11).
- Deterioration-Free Survival (DFS) Based on Physical Function (EORTC QLQ-C30): The HR for DFS physical functioning was 0.86 (95% Confidence Interval: 0.7 to 1.05). Reported percentages of participants with DFS were 6.9% and 3.9% for RegoNivo, and 6.3% and 0.7% for Standard of Care.
- Deterioration-Free Survival Rate Based on Global Health Status (EORTC QLQ-C30): The HR for DFS general health function was 0.74 (95% Confidence Interval: 0.6 to 0.91). Reported percentages of participants with DFS were 6.9% for RegoNivo and 5.6% for Standard of Care.
What this means
The Phase 3 RegoNivo trial in refractory advanced gastro-oesophageal cancer did not meet its primary objective of significantly improving overall survival compared to standard of care chemotherapy, as indicated by the median OS of 5.91 months versus 6.28 months and a non-significant p-value of 0.23. However, the combination therapy did show a notable increase in objective tumor response rate, with 23 participants achieving a response in the RegoNivo arm compared to 4 participants in the standard of care arm, and an Odds Ratio of 2.99. Additionally, the Hazard Ratio for Deterioration-Free Survival based on global health status was 0.74 (95% CI 0.6 to 0.91), suggesting a potential benefit in maintaining patient quality of life aspects. While the lack of OS benefit is a key finding, the improved response rates and potential impact on global health status may warrant further investigation into specific patient subgroups or alternative endpoints.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04879368, titled "RegoNivo vs Standard of Care Chemotherapy in AGOC", were posted on 2026-06-10 on clinicaltrials.gov.