Design
toxicity, Schema
ADVERSE EVENTS, DISEASE PROGRESSION
INTEGRATE IIa is a prospective, multi-centre, comparative, double-blinded phase III RCT where participants with histological or cytological confirmation of AGOC or undifferentiated carcinoma of primary gastro-oesophageal origin are randomised 2:1 to receive either regorafenib monotherapy (Arm A) or placebo (Arm B) (Fig. Schema of INTEGRATE IIaINTEGRATE IIb is a prospective, multi-centre, comparative, open label phase III RCT where participants with histological or cytological confirmation of AGOC or undifferentiated carcinoma of primary gastro-oesophageal origin are randomised 2:1 to receive regorafenib and nivolumab (experimental arm) or investigator’s choice of chemotherapy (control arm) (Fig. Schema of INTEGRATE IIbFor INTEGRATE IIa and INTEGRATE IIb, all treatments are to be administered until disease progression, unacceptable toxicity, withdrawal of consent, more than 2 dose reductions due to treatment related adverse events or day 1 treatment delays of longer than 28 days. Randomisation will be performed centrally. Participant quality of life (QOL) questionnaires are to be completed on cycle 1 day 1 of treatment and every 4 weeks thereafter during treatment and at the time of disease progression. Participants who end treatment before disease progression will have QOL data collected every 8 weeks until disease progression. A list of participating centres is provided in Table List of Participating Centres for INTEGRATE IIaList of Participating Centres for INTEGRATE IIb