CA209-9DX: phase III, randomized, double-blind study of adjuvant nivolumab vs placebo for patients with hepatocellular carcinoma (HCC) at high risk of recurrence after curative resection or ablation

作者：Maria Jesus Jimenez Exposito, Mehmet Akce, José Luís Montero Álvarez, Eric Assénat, Louis Balart, Aurore Baron, Thomas Decaens, Alexandra Heurgué–Berlot, A. Martin, Seung Woon Paik, Valerie Poulart, Aasim Sehbai, Nobuyuki Takemura, Jung‐Hwan Yoon · 发表于：Annals of Oncology · 年份：2018 · DOI：10.1093/annonc/mdy282.166 · 被引用次数：20 · 研究领域：Cancer Immunotherapy and Biomarkers、Cancer Genomics and Diagnostics、Hepatocellular Carcinoma Treatment and Prognosis

Background: Despite significant improvements in the treatment of early HCC, curative therapies remain associated with high recurrence rates (≈70% at 5 y) (EASL. J Hepatol 2018), and therefore, adjuvant therapies are needed. Nivolumab (NIVO) has demonstrated durable tumor responses and a manageable safety profile in patients (pts) with advanced HCC, regardless of HCC etiology (CheckMate-040 study) (El-Khoueiry, et al. Lancet 2017). Additionally, NIVO has shown clinical benefit as adjuvant therapy in melanoma (CheckMate-238 study) (Weber, et al. NEJM 2017). This phase 3, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of adjuvant NIVO in pts with HCC who are at high risk of recurrence after curative hepatic resection or ablation, a population for whom no effective therapies are currently available. Trial design: The trial will include 530 pts aged ≥18 y with a first diagnosis of HCC (any etiology) who are at high risk for HCC recurrence after curative resection or ablation, and who have well-preserved liver function (Child-Pugh score 5 or 6), randomized (1:1) to receive NIVO (480 mg intravenous Q4W) or placebo (PBO). Additional eligibility criteria include Eastern Cooperative Oncology Group performance status of 0 or 1, no evidence of tumor metastasis, no prior therapy for HCC (including loco-regional therapies), and no liver transplant. Pts will be treated until recurrence per blinded independent central review (BICR) assessment, unacce...