PDF(Pubmed)
Abstract：
Advances in immunotherapy utilizing immune checkpoint inhibitors (ICIs) have transformed the treatment landscapes of several malignancies in recent years. Oncologists are now tasked with extending these benefits to a greater number of patients and tumor types. Metastatic castration-resistant prostate cancer (mCRPC) infrequently responds to ICIs, while the cellular vaccine approved for mCRPC, sipuleucel-T, provides a 4-month survival benefit but does not produce clinical responses as monotherapy. However, many novel and generally well-tolerated immune oncology agents with potential for immune synergy and/or additive effects are undergoing clinical development. This availability presents opportunities to develop adaptive-design combination clinical trials aimed to generate, expand, and facilitate antitumor immune responses. Here we describe a currently accruing phase I/II trial (NCT03493945) testing a brachyury-targeted antitumor vaccine, TGF-β TRAP/anti-PD-L1 antibody, an IL-15 agonist, and an IDO1 inhibitor in mCRPC.
This trial ( NCT03493945 ) was registered in National Clinical Trials on April 11th 2018.
This trial ( NCT03493945 ) was registered in National Clinical Trials on April 11th 2018.
摘要：
近年来，利用免疫检查点抑制剂（ICI）进行免疫治疗的进展已经改变了几种恶性肿瘤的治疗前景。肿瘤学家现在的任务是将这些益处扩展到更多的患者和肿瘤类型。转移性去势抵抗性前列腺癌（mCRPC）很少对ICIs有反应，虽然细胞疫苗被批准用于mCRPC，sipuleucel-T,提供4个月的生存获益，但作为单一疗法不产生临床反应。然而,许多具有免疫协同和/或累加效应潜力的新型且通常耐受性良好的免疫肿瘤药物正在临床开发中.这种可用性提供了开发自适应设计组合临床试验的机会，旨在产生，展开,并促进抗肿瘤免疫反应。在这里，我们描述了一项目前正在进行的I/II期试验（NCT03493945），该试验测试了一种短尾分子靶向抗肿瘤疫苗，TGF-βTRAP/抗PD-L1抗体,IL-15激动剂，和mCRPC中的IDO1抑制剂。
该试验（NCT03493945）于2018年4月11日在国家临床试验中注册。
该试验（NCT03493945）于2018年4月11日在国家临床试验中注册。
