Clinical trial NCT03569436: Effectiveness and Safety of Nivolumab in Participants That Have Head and Neck Cancer That Has Come Back or Has Spread
Official title: Efficacy and Safety of Nivolumab in Recurrent or Metastatic Head and Neck Cancer (HNC) Patients - Japanese Real-world Data Through Clinical Chart Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of Head and Neck
Cancer of the Head
Cancer of the Neck
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharma USA Inc
First posted: 2018-06-26
Enrollment: 262
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recurrent/Metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) participants on nivolumab who progressed on or after platinum therapy

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


Eligibility criteria: 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/exclusion criteria could apply

Primary outcomes:
measure: Distribution of drug therapy treatment information
timeFrame: 6 months
measure: Distribution of non-drug therapy treatment information
timeFrame: 6 months
measure: Distribution of clinical laboratory testing
timeFrame: 6 months
measure: Distribution of participant information
timeFrame: 6 months
measure: Distribution of non-medication therapy treatment history
timeFrame: 12 months
measure: Distribution of therapeutic history
timeFrame: 12 months
measure: Overall survival
timeFrame: 12 months
measure: Progression free survival
timeFrame: 12 months
measure: Objective response rate
timeFrame: 12 months
measure: Duration of response
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of AE's
timeFrame: Up to 12 months
measure: Incidence of serious AE's
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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. Effectiveness of nivolumab affected by prior cetuximab use and neck dissection in Japanese patients with recurrent or metastatic head and neck cancer: results from a retrospective observational study in a real-world setting. Int J Clin Oncol. 2021 Jun;26(6):1049-1056. doi: 10.1007/s10147-021-01900-4. Epub 2021 Apr 8.
citation: Hanai N, Shimizu Y, Kariya S, 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, Sakurai D, Asakage T, Doi I, Yamada T, Homma A. Effectiveness and safety of nivolumab in patients with head and neck cancer in Japanese real-world clinical practice: a multicenter retrospective clinical study. Int J Clin Oncol. 2021 Mar;26(3):494-506. doi: 10.1007/s10147-020-01829-0. Epub 2020 Nov 21.