Study objectives
tumor, esophagogastric carcinoma
SECONDARY, TUMOR, METASTATIC CANCER
The primary endpoint of the study was the safety of the combination and to establish a RP2D. A final RP2D was to be established by the study steering committee at the conclusion of all accrued dose cohorts. Initial secondary efficacy endpoints included PFS, OS (median and at 1 year), and ORR for patients in the planned expansion cohorts of esophagogastric carcinoma and in patients with metastatic cancers refractory to prior PD-1 targeted treatment. We also planned to investigate the relationship between PD-L1 expression on tumor cells and on immune cells in the tumor microenvironment before and after treatment initiation. The expansion cohorts were not pursued due to perceived limited efficacy by the funding body, and a decision was made to perform exploratory post-hoc analyses to evaluate efficacy in the dose escalation patients. Pre-planned exploratory objectives included investigating changes in PD-L1 expression in tumor biopsy samples and in peripheral blood in relation to response, as well as the effect of IFN-γ administration on changes in known IFN-γ markers. Post-hoc, we elected to perform an exploratory cytokine analysis from plasma at various time points to associate with incidence of irAEs.