Center for Outcomes Research, Houston Methodist Hospital, Houston, TX 77030, USA.
Department of Urology, Houston Methodist Hospital, Houston, TX 77030, USA.
Future Oncol. 2022 Aug;18(25):2771-2781. doi: 10.2217/fon-2022-0380. Epub 2022 Jun 15.
The utilization of neoadjuvant immune checkpoint inhibitor therapy, specifically anti-PD-1/L1 agents, prior to radical cystectomy is an emerging paradigm in muscle-invasive bladder cancer (MIBC). vaccination represents a strategy to manipulate the tumor in order to augment the immune response toward improved local and distant cancer control. The authors describe the study rationale, design and objectives for RAD VACCINE MIBC, a single-arm, single-institution, phase II trial evaluating the efficacy and safety of combination neoadjuvant sasanlimab (humanized IgG monoclonal antibody that targets PD-1) with stereotactic body radiotherapy as an vaccine in cisplatin-ineligible patients with MIBC. The results from this trial will establish the safety profile of this combination strategy and evaluate pathologic complete response rates.
新辅助免疫检查点抑制剂治疗（特别是抗 PD-1/L1 药物）在根治性膀胱切除术之前用于肌层浸润性膀胱癌（MIBC）是一种新兴的模式。疫苗接种是一种操纵肿瘤的策略，旨在增强免疫反应，以改善局部和远处癌症控制。作者描述了 RAD VACCINE MIBC 的研究原理、设计和目标，这是一项单臂、单中心、二期试验，评估了在顺铂禁忌的 MIBC 患者中联合使用 sasanlimab（一种针对 PD-1 的人源化 IgG 单克隆抗体）和立体定向体放射疗法作为疫苗的疗效和安全性。该试验的结果将确定这种联合策略的安全性概况，并评估病理完全缓解率。
