Cancer of Head and NeckNCT03569436
Effectiveness and Safety of Nivolumab in Participants That Have Head and Neck Cancer That Has Come Back or Has Spread
An observational study of Cancer of Head and Neck and Cancer of the Head, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
Non-interventional study in Japan of participants with HNC recurring or that has spread and who are treated with nivolumab Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer of Head and Neck, Cancer of the Head, Cancer of the Neck
- How many people
- 262 participants
- Where
- 1 siteJapan
- Study dates
- 14 Feb 2018to 26 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- History of participation in any clinical trials prior- or post-nivolumab treatment
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
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
Non-interventional study in Japan of participants with HNC recurring or that has spread and who are treated with nivolumab
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic head and neck participants in Japan | Study in Japan targeting recurrent/metastatic HNC patients who are treated with nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of drug therapy treatment information
Measured: 6 months
Distribution of non-drug therapy treatment information
Measured: 6 months
Distribution of clinical laboratory testing
Measured: 6 months
Distribution of participant information
Measured: 6 months
Distribution of non-medication therapy treatment history
Measured: 12 months
Distribution of therapeutic history
Measured: 12 months
Overall survival
Measured: 12 months
Progression free survival
Measured: 12 months
Objective response rate
Measured: 12 months
Duration of response
Measured: 12 months
Secondary outcomes (2)
Incidence of AE's
Measured: Up to 12 months
Incidence of serious AE's
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start14 Feb 2018
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharma USA Inc
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569436
- Sponsor's protocol ID
- CA209-8DD
- Status last verified
- Jan 2022
- First submitted
- 15 Jun 2018
- Last updated
- 10 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 33830342Hanai 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.
PubMed 33219460
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03569436
- Acronym / sponsor ID
- CA209-8DD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharma USA Inc
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-interventional study in Japan of participants with HNC recurring or that has spread and who are treated with nivolumab
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic head and neck participants in Japan | – | –Study in Japan targeting recurrent/metastatic HNC patients who are treated with nivolumab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- History of participation in any clinical trials prior- or post-nivolumab treatment
- Other protocol defined inclusion/exclusion criteria could apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Incidence of AE's
Time frame: Up to 12 months
Incidence of serious AE's
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Derived from this study: PubMed 33830342Kariya 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.
- Derived from this study: PubMed 33219460Hanai 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.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Head and Neck and Cancer of the Head, run by Bristol-Myers Squibb at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of drug therapy treatment information (time frame: 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569436, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.