CREST: phase III study of sasanlimab and Bacillus Calmette-Guérin for patients with Bacillus Calmette-Guérin-naïve high-risk non-muscle-invasive bladder cancer.

IF 3 4区 医学 Q2 ONCOLOGY Future oncology Pub Date : 2024-05-01 Epub Date: 2024-01-08 DOI:10.2217/fon-2023-0271
Gary D Steinberg, Neal D Shore, Joan Palou Redorta, Matthew D Galsky, Jens Bedke, Ja Hyeon Ku, Michal Kretkowski, Hailong Hu, Konstantin Penkov, Jennifer J Vermette, Jamal C Tarazi, Alison E Randall, Kristen J Pierce, Daniel Saltzstein, Thomas B Powles
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Abstract

Bacillus Calmette-Guérin (BCG) is the standard of care for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumor (TURBT). BCG in combination with programmed cell death-1 (PD-1) inhibitors may yield greater anti-tumor activity compared with either agent alone. CREST is a phase III study evaluating the efficacy and safety of the subcutaneous PD-1 inhibitor sasanlimab in combination with BCG for patients with BCG-naive high-risk NMIBC. Eligible participants are randomized to receive sasanlimab plus BCG (induction ± maintenance) or BCG alone for up to 25 cycles within 12 weeks of TURBT. The primary outcome is event-free survival. Secondary outcomes include additional efficacy end points and safety. The target sample size is around 1000 participants.

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CREST:沙生利单抗和卡介苗治疗卡介苗无效的高危非肌层浸润性膀胱癌患者的III期研究。
卡介苗(BCG)是经尿道膀胱肿瘤切除术(TURBT)后高危非肌浸润性膀胱癌(NMIBC)患者的标准治疗方法。卡介苗与程序性细胞死亡-1(PD-1)抑制剂联合使用可能比单独使用其中一种药物产生更强的抗肿瘤活性。CREST是一项III期研究,评估皮下注射PD-1抑制剂sasanlimab联合卡介苗治疗卡介苗无效的高危NMIBC患者的疗效和安全性。符合条件的参与者将随机接受沙生利单抗联合卡介苗(诱导±维持)或单用卡介苗,在TURBT后12周内最多可接受25个周期的治疗。主要结果是无事件生存期。次要结果包括其他疗效终点和安全性。目标样本量约为 1000 人。
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来源期刊
Future oncology
Future oncology ONCOLOGY-
CiteScore
5.40
自引率
3.00%
发文量
335
审稿时长
4-8 weeks
期刊介绍: Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community. The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.
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