INTEGRATE IIb: A Randomised Phase III Open Label Study of regorafenib + nivolumab vs standard chemotherapy in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)

AGOC has a poor prognosis, and there is no established standard treatment following failure of first- and second-line chemotherapy. Regorafenib (BAY 73-4506) is an investigational oral multi-targeted tyrosine kinase inhibitor (TKI) which targets angiogenic (VEGF, TIE-2), stromal (PDGF-β), and oncogenic (RAF, RET and KIT) receptor tyrosine kinases, and has shown activity in other solid tumours. Regorafenib was shown to prolong PFS across all regions/subgroups in the INTEGRATE Phase II trial. The INTEGRATE II Phase III trial commenced aiming to determine if regorafenib improves overall survival in refractory AGOC. The INTEGRATE II study was amended in December 2019 into two separate trials; INTEGRATE IIa (Regorafenib v placebo; presented at ASCO 2023, publication submitted) and IIb.