Study of Intratumoral Ipilimumab and TLR4 Agonist GLA-SE in Combination With Systemic Nivolumab and Chemotherapy

To determine the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D) and the toxicity profile (NCI CTCAE v5.0 and immune related adverse events) of i.t. administration of anti-CTLA4 antibody (ipilimumab) and TLR4 agonist (synthetic glucopyranosyl lipid A formulated in a stable emulsion [GLA-SE]) in colorectal LM (CRLM) in combination with intravenous (i.v.) administration of anti-PD-1 antibody (nivolumab) and chemotherapy (FOLFOX regimen).

本研究旨在明确结直肠肝转移（colorectal liver metastases, CRLM）患者接受瘤内（intratumoral, i.t.）注射抗CTLA4抗体（ipilimumab，伊匹木单抗）与TLR4激动剂（稳定乳剂配制的合成吡喃葡萄糖基脂质A [GLA-SE]），联合静脉（intravenous, i.v.）注射抗PD-1抗体（nivolumab，纳武利尤单抗）及FOLFOX方案化疗后的最大耐受剂量（maximum tolerated dose, MTD）、Ⅱ期推荐剂量（recommended phase 2 dose, RP2D）以及毒性谱，该毒性谱的评估采用美国国家癌症研究所常见不良反应术语评价标准5.0版（NCI CTCAE v5.0）与免疫相关不良事件标准。