Effectiveness and Safety of Nivolumab in Participants That Have Head and Neck Cancer That Has Come Back or Has Spread

Conditions

Cancer of Head and Neck, Cancer of the Head, Cancer of the Neck

Brief summary

Non-interventional study in Japan of participants with HNC recurring or that has spread and who are treated with nivolumab

Kariya S, Shimizu Y, Hanai N, Yasumatsu R, Yokota T, Fujii T, Tsukahara K, Yoshida M, Hanyu K, Ueda T, Hirakawa H, Takahashi S, Ono T, Sano D, Yamauchi M, Watanabe A, Omori K, Yamazaki T, Monden N, Kudo N, Arai M, Yonekura S, Asakage T, Fujiwara A, Yamada T, Homma A.

2021-04-084 citations

10.1007/s10147-021-01900-4

Effectiveness and safety of nivolumab in patients with head and neck cancer in Japanese real-world clinical practice: a multicenter retrospective clinical study

Nobuhiro Hanai, Yasushi Shimizu, Shin Kariya, Ryuji Yasumatsu, Tomoya Yokota et al. (26 authors)

International Journal of Clinical Oncology2020-11-2154 citations

10.1007/s10147-020-01829-0

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* Recurrent/metastatic HNC patients with disease progression on or after a platinum-based therapy treated with nivolumab at least once from 01-Jul-2017 through 31-Dec-2017

Exclusion criteria

* History of participation in any clinical trials prior- or post-nivolumab treatment Other protocol defined inclusion/

Design outcomes

Primary

Measure	Time frame
Duration of response	12 months
Progression free survival	12 months
Objective response rate	12 months
Distribution of drug therapy treatment information	6 months
Distribution of non-drug therapy treatment information	6 months
Distribution of clinical laboratory testing	6 months
Distribution of participant information	6 months
Distribution of non-medication therapy treatment history	12 months
Distribution of therapeutic history	12 months
Overall survival	12 months

Secondary

Measure	Time frame
Incidence of serious AE's	Up to 12 months
Incidence of AE's	Up to 12 months

Countries

Japan

Outcome results