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JAVELIN Head and Neck 100：avelumab 联合放化疗治疗局部晚期头颈部癌的 III 期临床试验。

JAVELIN Head and Neck 100: a Phase III trial of avelumab and chemoradiation for locally advanced head and neck cancer.

机构信息

Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.

出版信息

Future Oncol. 2019 Mar;15(7):687-694. doi: 10.2217/fon-2018-0405. Epub 2018 Nov 21.

DOI:10.2217/fon-2018-0405
PMID:30461306
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11835014/
Abstract

Chemoradiotherapy (CRT) is the standard of care for locoregionally advanced squamous cell carcinomas of the head and neck (HNSCC). The immune checkpoint inhibitors nivolumab and pembrolizumab were recently approved by the US FDA for treatment of recurrent or metastatic HNSCC that are refractory to platinum chemotherapy. However, prospective studies incorporating immune checkpoint inhibitors in the definitive management of poor prognosis, nonmetastatic, locoregionally advanced HNSCC are lacking. The JAVELIN Head and Neck 100 study is a multinational, Phase III, double-blind, placebo-controlled, randomized clinical trial assessing the efficacy of avelumab, a PD-L1 inhibitor, in combination with CRT compared with placebo in combination with CRT for high-risk HNSCC. Trial registration: Javelin Head and Neck 100; NCT 02952586.

摘要

化放疗（CRT）是局部晚期头颈部鳞状细胞癌（HNSCC）的标准治疗方法。美国食品和药物管理局（FDA）最近批准免疫检查点抑制剂纳武单抗和帕博利珠单抗用于治疗对铂类化疗耐药的复发性或转移性 HNSCC。然而，在明确治疗预后不良、非转移性、局部晚期 HNSCC 方面，缺乏包含免疫检查点抑制剂的前瞻性研究。JAVELIN Head and Neck 100 研究是一项多中心、III 期、双盲、安慰剂对照、随机临床试验，旨在评估 PD-L1 抑制剂avelumab 联合 CRT 与安慰剂联合 CRT 治疗高危 HNSCC 的疗效。试验注册：Javelin Head and Neck 100；NCT 02952586。

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JAVELIN Head and Neck 100: a Phase III trial of avelumab and chemoradiation for locally advanced head and neck cancer.

Future Oncol. 2018-11-21

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本文引用的文献

[1]
Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC.

N Engl J Med. 2018-9-25

[2]
Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial.

Lancet Oncol. 2017-12-5

[3]
Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer.

N Engl J Med. 2017-9-8

[4]
Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial.

Lancet Oncol. 2017-5

[5]
Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer (JAVELIN Solid Tumor): dose-expansion cohort of a multicentre, open-label, phase 1b trial.

Lancet Oncol. 2017-5

[6]
Pembrolizumab for Platinum- and Cetuximab-Refractory Head and Neck Cancer: Results From a Single-Arm, Phase II Study.

J Clin Oncol. 2017-5-10

[7]
The intersection of radiotherapy and immunotherapy: mechanisms and clinical implications.

Sci Immunol. 2016-9

[8]
Amidst the excitement: A cautionary tale of immunotherapy, pseudoprogression and head and neck squamous cell carcinoma.

Oral Oncol. 2016-11

[9]
Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck.

N Engl J Med. 2016-11-10

[10]
Antitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort.

J Clin Oncol. 2016-11-10

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