Kurzfassung

This is a multicenter, randomized, open-label, docetaxel- or paclitaxel-controlled study where ONO-4538 is administered at 2-week intervals for the treatment of patients with esophageal cancer refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs, with 1 prior regimen to evaluate the efficacy and safety of ONO-4538. Patients will be randomized in a 1:1 ratio to the ONO-4538 group or control group (docetaxel or paclitaxel), and will be stratified by...This is a multicenter, randomized, open-label, docetaxel- or paclitaxel-controlled study where ONO-4538 is administered at 2-week intervals for the treatment of patients with esophageal cancer refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs, with 1 prior regimen to evaluate the efficacy and safety of ONO-4538. Patients will be randomized in a 1:1 ratio to the ONO-4538 group or control group (docetaxel or paclitaxel), and will be stratified by region (Japan vs. rest of world) and number of organs with metastases (≤1 vs. ≥2) and expression of PD-L1 (≥1% vs. <1% or indeterminate). After randomization, the ONO-4538 group will receive ONO-4538 (240 mg at 2-week intervals) and the control group will receive docetaxel (75mg/m² at 3-week intervals) or paclitaxel (100 mg/m² for 6 weeks in succession followed by 2-week drug holiday). The primary endpoint is OS, based on which the superiority of ONO-4538 over the control group will be investigated.
In this study, an interim analysis will be performed when approximately 60% (199 events) of the required 331 events for OS analysis occurs.» weiterlesen» einklappen