The Phase 3 clinical trial (NCT04879368) investigating the combination of regorafenib and nivolumab (RegoNivo) against standard chemotherapy in advanced gastro-oesophageal cancer reached its primary completion on 2025-07-09. This study, titled "RegoNivo vs Standard of Care Chemotherapy in AGOC," enrolled 450 participants to evaluate treatment outcomes.
Background
Nivolumab is an immunotherapy drug, and regorafenib is a multi-kinase inhibitor. This trial specifically investigates the combination of regorafenib and nivolumab (RegoNivo) as a potential treatment strategy. The study focuses on advanced gastro-oesophageal cancer (AGOC), a challenging condition where patients often have limited treatment options, particularly in refractory cases.
Trial design
The Phase 3 trial, NCT04879368, is a study titled "RegoNivo vs Standard of Care Chemotherapy in AGOC." It enrolled 450 participants with gastro-oesophageal cancer. The study's primary objective is to determine if the combination of regorafenib and nivolumab (RegoNivo) improves overall survival compared with current standard chemotherapy options in refractory advanced gastro-oesophageal cancer. The comparator arms include standard of care chemotherapy options such as docetaxel, paclitaxel, and irinotecan.
What this means
The primary completion of the Phase 3 RegoNivo trial signifies a significant milestone in the study of new treatment approaches for advanced gastro-oesophageal cancer. While specific results are not yet available, the completion indicates that the main data collection phase for the primary endpoint has concluded. Future data releases will provide insights into whether the combination of regorafenib and nivolumab offers a survival benefit over standard chemotherapy in this patient population.
Source
Information regarding the primary completion of trial NCT04879368 was obtained from ClinicalTrials.gov, a public database of clinical studies. The event was recorded on 2025-07-09 on clinicaltrials.gov.