Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2019 Mar;15(7):687-694.
doi: 10.2217/fon-2018-0405. Epub 2018 Nov 21.

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

Yao Yu  1 , Nancy Y Lee  1
Affiliations
Clinical Trial

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

Yao Yu et al. Future Oncol. 2019 Mar.

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.

Keywords: PD-1; PD-L1; chemoradiotherapy; head and neck; immune checkpoint blockade; immunotherapy; locally advanced.

PubMed Disclaimer

Conflict of interest statement

Y Yu has no relevant disclosures. NY Lee is an international principal investigator for the Javelin Head and Neck 100 study. She has also served as an advisor and consultant for Pfizer, Merck, Merck GMO, Sanofi Aventis and Lily. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Figures

Figure 1.
Figure 1.. Study design.
CRT: Chemoradiotherapy; OS: Overall survival.
See this image and copyright information in PMC

References

    1. Ferlay J, Soerjomataram I, Dikshit Ret al. . Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int. J. Cancer 136(5), e359–e386 (2015). - PubMed
    1. Grégoire V, Lefèbvre JL, Licitra Let al. . Squamous cell carcinoma of the head and neck: EHNS-ESMO-ESTRO clinical practice guidelines for diagnosis, treatment and follow-up. Ann. Oncol. 21(Suppl. 5), 184–186 (2010). - PubMed
    1. Ang KK, Harris J, Wheeler Ret al. . Human papillomavirus and survival of patients with oropharyngeal cancer. N. Engl. J. Med. 363(1), 24–35 (2010). - PMC - PubMed
    1. O’Sullivan B, Huang SH, Su Jet al. . Development and validation of a staging system for HPV-related oropharyngeal cancer by the International Collaboration on Oropharyngeal cancer Network for Staging (ICON-S): a multicentre cohort study. Lancet Oncol. 17(4), 440–451 (2016). - PubMed
    1. Ang KK, Zhang Q, Rosenthal DIet al. . Randomized Phase III trial of concurrent accelerated radiation plus cisplatin with or without cetuximab for stage III to IV head and neck carcinoma: RTOG 0522. J. Clin. Oncol. 32(27), 2940–2950 (2014). - PMC - PubMed

Publication types

MeSH terms

LinkOut - more resources