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

NCT03569436 | Completed

• 1 other identifier: CA209-8DD
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (10)

• 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

Secondary Outcomes (2)

• Incidence of AE's

  Up to 12 months

• Incidence of serious AE's

  Up to 12 months

Study Arms (1)

Metastatic head and neck participants in Japan

Study in Japan targeting recurrent/metastatic HNC patients who are treated with nivolumab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharma USA Inc: collaborator

Study Sites (1)

Local Institution

Tokyo, 1070052, Japan

Location

Related Publications (2)

• 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.

  PMID: 33830342 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.

  PMID: 33219460 DERIVED

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: June 26, 2018
• Study Start: February 14, 2018
• Primary Completion: June 26, 2020
• Study Completion: June 26, 2020
• Last Updated: February 10, 2022

Record last verified: 2022-01

Locations

JP (1)