Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
Department of Urology, Carolina Urologic Research Center, Myrtle Beach, SC 29572, USA.
Future Oncol. 2020 Apr;16(10):507-516. doi: 10.2217/fon-2019-0817. Epub 2020 Mar 12.
Nonmuscle-invasive bladder cancer (NMIBC) is the most common form of bladder cancer, with high rates of disease recurrence and progression. Current treatment for high-risk NMIBC involves Bacillus Calmette-Guérin (BCG) therapy, but treatment options are limited for patients with recurrent or BCG-unresponsive disease. Aberrant programmed death 1 signaling has been implicated in BCG resistance and bladder cancer recurrence and progression, and pembrolizumab has shown efficacy in patients with BCG-unresponsive high-risk NMIBC. To describe the rationale and design for the randomized, comparator-controlled Phase III KEYNOTE-676 study, which will evaluate the efficacy and safety of pembrolizumab in combination with BCG in patients with persistent/recurrent high-risk NMIBC after BCG induction therapy. NCT03711032.
非肌肉浸润性膀胱癌（NMIBC）是最常见的膀胱癌形式，具有高复发和进展率。目前，高危 NMIBC 的治疗方法包括卡介苗（BCG）治疗，但对于复发性或 BCG 无反应性疾病的患者，治疗选择有限。异常程序性死亡 1 信号已被牵连到 BCG 耐药和膀胱癌复发和进展中，并且 pembrolizumab 已在 BCG 无反应性高危 NMIBC 患者中显示出疗效。 描述了随机、对照对照 III 期 KEYNOTE-676 研究的基本原理和设计，该研究将评估 pembrolizumab 联合 BCG 在 BCG 诱导治疗后持续性/复发性高危 NMIBC 患者中的疗效和安全性。 NCT03711032。
