Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ono Pharma USA Inc | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Non-interventional study in Japan of participants with HNC recurring or that has spread and who are treated with nivolumab
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic head and neck participants in Japan | Study in Japan targeting recurrent/metastatic HNC patients who are treated with nivolumab |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Progression free survival | 12 months | |
| Objective response rate | 12 months | |
| Duration of response | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AE's | Up to 12 months | |
| Incidence of serious AE's | Up to 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
Not provided
Not provided
Not provided
Not provided
Recurrent/Metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) participants on nivolumab who progressed on or after platinum therapy
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Tokyo | 1070052 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33830342 | Derived | 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. | |
| 33219460 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Derived |
| 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. |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |