PDF(Pubmed)
Abstract：
UNASSIGNED: Globally, head and neck squamous cell carcinoma (HNSCC) is the seventh most common malignancy. Despite aggressive multimodal treatment approaches, recurrent and/or metastatic (R/M) disease develops in >50% of patients. In this setting, pembrolizumab was approved for patients with PD-L1 expression. However, response rates with checkpoint inhibitor monotherapy remain limited and strategies to strengthen tumor-directed immune responses are needed.
UNASSIGNED: The FOCUS trial is designed to estimate the effectiveness of UV1 vaccination in combination with pembrolizumab versus pembrolizumab as a single agent in patients with R/M HNSCC.
UNASSIGNED: The FOCUS trial is a two-armed, randomized, multicenter phase II study which was designed to evaluate the efficacy and feasibility of the hTERT-targeted cancer vaccine UV1 as add-on to pembrolizumab in the 1st line treatment of patients with R/M PD-L1 positive (combined positive score ≥1) HNSCC. Secondary objectives are the exploration of patient subgroups most likely deriving benefit from this novel combination and the establishment of liquid biopsy tumor monitoring in HNSCC.
UNASSIGNED: This clinical study was designed and will be conducted in compliance with Good Clinical Practice and in accordance with the Declaration of Helsinki. It is intended to publish the results of this study in peer-reviewed scientific journals and to present its content at academic conferences.
UNASSIGNED: A significant number of patients with R/M HNSCC are frail and may not tolerate chemotherapy, these patients may only be suitable for pembrolizumab monotherapy. However, long term disease stabilizations remain the exception and there is a need for the development of efficacious combination regimens for this patient population. The FOCUS study aims to optimize treatment of R/M HNSCC patients with this promising new treatment approach.
UNASSIGNED: https://clinicaltrials.gov/study/NCT05075122, identifier NCT05075122.
UNASSIGNED: The FOCUS trial is designed to estimate the effectiveness of UV1 vaccination in combination with pembrolizumab versus pembrolizumab as a single agent in patients with R/M HNSCC.
UNASSIGNED: The FOCUS trial is a two-armed, randomized, multicenter phase II study which was designed to evaluate the efficacy and feasibility of the hTERT-targeted cancer vaccine UV1 as add-on to pembrolizumab in the 1st line treatment of patients with R/M PD-L1 positive (combined positive score ≥1) HNSCC. Secondary objectives are the exploration of patient subgroups most likely deriving benefit from this novel combination and the establishment of liquid biopsy tumor monitoring in HNSCC.
UNASSIGNED: This clinical study was designed and will be conducted in compliance with Good Clinical Practice and in accordance with the Declaration of Helsinki. It is intended to publish the results of this study in peer-reviewed scientific journals and to present its content at academic conferences.
UNASSIGNED: A significant number of patients with R/M HNSCC are frail and may not tolerate chemotherapy, these patients may only be suitable for pembrolizumab monotherapy. However, long term disease stabilizations remain the exception and there is a need for the development of efficacious combination regimens for this patient population. The FOCUS study aims to optimize treatment of R/M HNSCC patients with this promising new treatment approach.
UNASSIGNED: https://clinicaltrials.gov/study/NCT05075122, identifier NCT05075122.
摘要：
■全球，头颈部鳞状细胞癌（HNSCC）是第七常见的恶性肿瘤。尽管采取了积极的多模式治疗方法，>50%的患者发生复发性和/或转移性(R/M)疾病。在此设置中，派姆单抗被批准用于PD-L1表达患者。然而,检查点抑制剂单药治疗的应答率仍然有限,因此需要加强肿瘤导向免疫应答的策略.
■FOCUS试验旨在评估UV1疫苗与pembrolizumab联合使用与pembrolizumab作为单一药物在R/MHNSCC患者中的有效性。
■FOCUS审判是两臂的，随机化，多中心II期研究，旨在评估hTERT靶向癌症疫苗UV1作为pembrolizumab在R/MPD-L1阳性（合并阳性评分≥1）HNSCC患者一线治疗中的疗效和可行性。次要目标是探索最有可能从这种新型组合中受益的患者亚组，并在HNSCC中建立液体活检肿瘤监测。
■本临床研究的设计和实施将符合良好临床实践和赫尔辛基宣言。旨在在同行评审的科学期刊上发表这项研究的结果，并在学术会议上介绍其内容。
■大量R/MHNSCC患者身体虚弱，可能无法耐受化疗，这些患者可能仅适用于pembrolizumab单药治疗.然而,长期疾病稳定仍然是例外,因此需要为该患者人群开发有效的联合治疗方案.FOCUS研究旨在使用这种有前途的新治疗方法优化R/MHNSCC患者的治疗。
■https://clinicaltrials.gov/study/NCT05075122，标识符NCT05075122。
■FOCUS试验旨在评估UV1疫苗与pembrolizumab联合使用与pembrolizumab作为单一药物在R/MHNSCC患者中的有效性。
■FOCUS审判是两臂的，随机化，多中心II期研究，旨在评估hTERT靶向癌症疫苗UV1作为pembrolizumab在R/MPD-L1阳性（合并阳性评分≥1）HNSCC患者一线治疗中的疗效和可行性。次要目标是探索最有可能从这种新型组合中受益的患者亚组，并在HNSCC中建立液体活检肿瘤监测。
■本临床研究的设计和实施将符合良好临床实践和赫尔辛基宣言。旨在在同行评审的科学期刊上发表这项研究的结果，并在学术会议上介绍其内容。
■大量R/MHNSCC患者身体虚弱，可能无法耐受化疗，这些患者可能仅适用于pembrolizumab单药治疗.然而,长期疾病稳定仍然是例外,因此需要为该患者人群开发有效的联合治疗方案.FOCUS研究旨在使用这种有前途的新治疗方法优化R/MHNSCC患者的治疗。
■https://clinicaltrials.gov/study/NCT05075122，标识符NCT05075122。
