Head and Neck CancerNCT03114163
Observational Study of Nivolumab in Participants in Germany With Squamous Cell Carcinoma of the Head and Neck (SCCHN) Progressing on or After Platinum-Based Therapy
An observational study of Head and Neck Cancer, run by Bristol-Myers Squibb at 1 site in Germany.
Trial summary
This is a German, observational study in adult participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) progressing on or after platinum-based therapy, who start a new systemic therapy with nivolumab in 1st line (cohort 2) or ≥2nd line (cohort 1) for the first time, and are treated within the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 485 participants
- Where
- 1 siteGermany
- Study dates
- 12 May 2017to 28 Apr 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll adult participants who are at least 18 years of age at the time of the treatment decision, with the diagnosis of Squamous Cell Carcinoma of the Head and Neck (SCCHN) (either initial diagnosis or during later course histologically or cytologically confirmed). It is mandatory that the physician has already decided to initiate a treatment with nivolumab as 1st line or ≥2nd line therapy for the first time for the treatment of SCCHN, according to the label approved in Germany.
Who may be able to join
- Adult participants (at least 18 years of age at time of treatment decision)
- Diagnosis of Squamous cell carcinoma of the head and neck (SCCHN) and participants are progressing on or after platinum-based therapy, administered for locally advanced, metastatic or recurrent disease (Cohort 2: prior platinum-based therapy was administered for locally advanced disease in the adjuvant or primary setting, e.g. radiotherapy)
- Diagnosis of SCCHN has been confirmed by histology or cytology (either at initial diagnosis or any time later during the course of the disease)
- Treatment decision to initiate a treatment with nivolumab for the first time for the treatment of SCCHN (according to the label approved in Germany) has already been taken
Who cannot join
- Current primary diagnosis of a cancer other than SCCHN, ie, a cancer other than SCCHN or cancer of unknown primary (CUP-syndrome) that requires systemic or other treatment, or has not been treated curatively (as per discretion of the investigator)
- Previously treated with nivolumab and/or ipilimumab, an anti-PD-1, anti-programmed death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways (applicable for any indication)
- Currently included in an interventional clinical trial for their SCCHN. Participants who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for Overall survival (OS) can be enrolled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN) Progressing on or After Platinum-Based Therapy
This is a German, observational study in adult participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) progressing on or after platinum-based therapy, who start a new systemic therapy with nivolumab in 1st line (cohort 2) or ≥2nd line (cohort 1) for the first time, and are treated within the market authorization approval. Participants are to be enrolled into the study no earlier than the decision to initiate treatment with nivolumab and no later than the first dose of nivolumab treatment.
- Conditions
- Head and Neck Cancer
- 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 |
|---|---|---|
| Cohort 1: Nivolumab | ≥2nd line treatment for recurrent/ metastatic (R/M) Squamous cell carcinoma of the head and neck (SCCHN), prior platinum-based therapy was administered for locally advanced, metastatic or recurrent disease | |
| Cohort 2: Nivolumab | 1st line treatment for R/M SCCHN, prior platinum-based therapy was administered for locally advanced disease in the adjuvant or primary setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: Up to 5 years
Secondary outcomes (17)
Overall Survival
Measured: Up to 5 years
Progression-Free Survival (PFS)
Measured: Up to 5 years
Time to progression
Measured: Up to 5 years
Overall Response Rate (ORR)
Measured: Up to 5 years
Best overall response rate (BORR)
Measured: Up to 5 years
Best overall response (BOR)
Measured: Up to 5 years
Tumor response (Investigator assessed)
Measured: Up to 5 years
Time to response (TTR)
Measured: Up to 5 years
Duration of response (DOR)
Measured: Up to 5 years
Description of socio-demographic characteristics of participants
Measured: Up to 5 years
Description of clinical characteristics of participants
Measured: Up to 5 years
Description of management of participants with treatment-related adverse events (AEs)
Measured: Up to 5 years
Description of incidence of AEs
Measured: Up to 5 years
Description of Severity of AEs
Measured: Up to 5 years
Description of management of AEs
Measured: Up to 5 years
Description of participant-reported outcomes (PROs) and health-related quality-of-life (QoL) of participants using the Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) questionnaires
Measured: Up to 5 years
Description of participant-reported outcomes (PROs) and health-related quality-of-life (QoL) of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start12 May 2017
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Prospective
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114163
- Sponsor's protocol ID
- CA209-99K
- Status last verified
- Jun 2025
- First submitted
- 10 Apr 2017
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN) Progressing on or After Platinum-Based Therapy
- ClinicalTrials.gov ID
- NCT03114163
- Acronym / sponsor ID
- CA209-99K
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 12 May 2017 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 14 Apr 2017 (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.
This is a German, observational study in adult participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) progressing on or after platinum-based therapy, who start a new systemic therapy with nivolumab in 1st line (cohort 2) or ≥2nd line (cohort 1) for the first time, and are treated within the market authorization approval. Participants are to be enrolled into the study no earlier than the decision to initiate treatment with nivolumab and no later than the first dose of nivolumab treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Nivolumab | – | –≥2nd line treatment for recurrent/ metastatic (R/M) Squamous cell carcinoma of the head and neck (SCCHN), prior platinum-based therapy was administered for locally advanced, metastatic or recurrent disease |
| Cohort 2: Nivolumab | – | –1st line treatment for R/M SCCHN, prior platinum-based therapy was administered for locally advanced disease in the adjuvant or primary setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll adult participants who are at least 18 years of age at the time of the treatment decision, with the diagnosis of Squamous Cell Carcinoma of the Head and Neck (SCCHN) (either initial diagnosis or during later course histologically or cytologically confirmed). It is mandatory that the physician has already decided to initiate a treatment with nivolumab as 1st line or ≥2nd line therapy for the first time for the treatment of SCCHN, according to the label approved in Germany.
Key inclusion criteria (4 listed)
- Adult participants (at least 18 years of age at time of treatment decision)
- Diagnosis of Squamous cell carcinoma of the head and neck (SCCHN) and participants are progressing on or after platinum-based therapy, administered for locally advanced, metastatic or recurrent disease (Cohort 2: prior platinum-based therapy was administered for locally advanced disease in the adjuvant or primary setting, e.g. radiotherapy)
- Diagnosis of SCCHN has been confirmed by histology or cytology (either at initial diagnosis or any time later during the course of the disease)
- Treatment decision to initiate a treatment with nivolumab for the first time for the treatment of SCCHN (according to the label approved in Germany) has already been taken
Key exclusion criteria (3 listed)
- Current primary diagnosis of a cancer other than SCCHN, ie, a cancer other than SCCHN or cancer of unknown primary (CUP-syndrome) that requires systemic or other treatment, or has not been treated curatively (as per discretion of the investigator)
- Previously treated with nivolumab and/or ipilimumab, an anti-PD-1, anti-programmed death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways (applicable for any indication)
- Currently included in an interventional clinical trial for their SCCHN. Participants who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for Overall survival (OS) can be enrolled
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
Overall Survival
Time frame: Up to 5 years
17 secondary outcomes
Overall Survival
Time frame: Up to 5 years
Progression-Free Survival (PFS)
Time frame: Up to 5 years
Time to progression
Time frame: Up to 5 years
Overall Response Rate (ORR)
Time frame: Up to 5 years
Best overall response rate (BORR)
Time frame: Up to 5 years
Best overall response (BOR)
Time frame: Up to 5 years
Tumor response (Investigator assessed)
Time frame: Up to 5 years
Time to response (TTR)
Time frame: Up to 5 years
Duration of response (DOR)
Time frame: Up to 5 years
Description of socio-demographic characteristics of participants
Time frame: Up to 5 years
Description of clinical characteristics of participants
Time frame: Up to 5 years
Description of management of participants with treatment-related adverse events (AEs)
Time frame: Up to 5 years
Description of incidence of AEs
Time frame: Up to 5 years
Description of Severity of AEs
Time frame: Up to 5 years
Description of management of AEs
Time frame: Up to 5 years
Description of participant-reported outcomes (PROs) and health-related quality-of-life (QoL) of participants using the Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) questionnaires
Time frame: Up to 5 years
Description of participant-reported outcomes (PROs) and health-related quality-of-life (QoL) of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires
Time frame: Up to 5 years
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 18 Jun 2025.
- BMS Clinical Trial InformationLink 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 Head and Neck Cancer, run by Bristol-Myers Squibb at 1 site in Germany.
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 4 inclusion and 3 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 18 Jun 2025. 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 Germany. 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?
Overall Survival (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2025.