Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.
Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Korea.
J Gynecol Oncol. 2019 Nov;30(6):e112. doi: 10.3802/jgo.2019.30.e112.
A single-arm phase II study of neoadjuvant chemotherapy plus durvalumab and tremelimumab in the treatment of advanced-stage ovarian cancer has begun in Korea. We hypothesized that adding durvalumab (anti-programmed death-ligand 1 antibody) and tremelimumab (anti-cytotoxic T-lymphocyte-associated protein 4 antibody) to chemotherapy in treating this cancer can increase progression-free survival (PFS) with minimal effects on safety.
During treatment, serial biopsies will be performed on pre-treatment, at interval debulking surgery and progression to identify immune biomarkers and changes in the tumor microenvironment. Patients with histologically confirmed stage IIIC/IV epithelial ovarian cancer are offered durvalumab, tremelimumab plus chemotherapy for neoadjuvant chemotherapy and durvalumab plus chemotherapy for adjuvant chemotherapy. Twenty-four patients will be included from four Korean institutions within 1 year. The primary endpoint is a 12-month PFS rate.
ClinicalTrials.gov Identifier: NCT03899610.
一项在韩国开始进行的新辅助化疗联合度伐利尤单抗和替西木单抗治疗晚期卵巢癌的单臂 II 期研究。我们假设在治疗这种癌症时，将度伐利尤单抗（抗程序性死亡配体 1 抗体）和替西木单抗（抗细胞毒性 T 淋巴细胞相关蛋白 4 抗体）添加到化疗中可以提高无进展生存期（PFS），而对安全性的影响最小。
在治疗期间，将对预处理、间隔减瘤手术和进展时进行的连续活检，以鉴定免疫生物标志物和肿瘤微环境的变化。组织学确诊为 IIIC/IV 期上皮性卵巢癌的患者将接受度伐利尤单抗、替西木单抗联合化疗的新辅助化疗和度伐利尤单抗联合化疗的辅助化疗。在 1 年内，将从四个韩国机构中纳入 24 例患者。主要终点是 12 个月的 PFS 率。
ClinicalTrials.gov 标识符：NCT03899610。
