CompletedNCT03569436Updated Feb 10, 2022

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

An observational study in Cancer of Head and Neck, Cancer of the Head and Cancer of the Neck, sponsored by Bristol-Myers Squibb. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2022-02-10.

Sponsored by Bristol-Myers Squibb · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 262
Sex: All

Study summary

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

Conditions studied

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

Browse trials for

Head and Neck Neoplasms 2,344

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 262 is above the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No
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

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

Exclusion Criteria:

History of participation in any clinical trials prior- or post-nivolumab treatment

Other protocol defined inclusion/exclusion criteria could apply

Study design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 262 participants (actual)
Patient registry: No

Groups and cohorts

Metastatic head and neck participants in Japan
Study in Japan targeting recurrent/metastatic HNC patients who are treated with nivolumab

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Local Institution
Tokyo, 1070052, Japan

References and documents

Publications

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. PubMed 33830342 ↗
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. Erratum In: Int J Clin Oncol. 2021 May;26(5):1005-1006. doi: 10.1007/s10147-021-01879-y. PubMed 33219460 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03569436
Lead sponsor: Bristol-Myers Squibb
Collaborators: Ono Pharma USA Inc
Responsible party: Sponsor
First posted: Jun 26, 2018
Start date: Feb 14, 2018
Primary completion: Jun 26, 2020
Completion: Jun 26, 2020
Last update: Feb 10, 2022

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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