Clinical trial · Observational
Effectiveness and Safety of Nivolumab in Participants That Have Head and Neck Cancer That Has Come Back or Has Spread
Efficacy and Safety of Nivolumab in Recurrent or Metastatic Head and Neck Cancer (HNC) Patients - Japanese Real-world Data Through Clinical Chart Review
NCT03569436CI-TRIAL-00056444completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Non-interventional study in Japan of participants with HNC recurring or that has spread and who are treated with nivolumab
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Cancer of the Head | Head and Neck Neoplasm | PROBABILISTIC | 0.70 |
| Cancer of the Neck | Malignant Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Metastatic head and neck participants in Japan
- description
- Study in Japan targeting recurrent/metastatic HNC patients who are treated with nivolumab
Primary outcomes (10)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDKariya 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. PMID 33830342
- DERIVEDHanai 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. PMID 33219460