Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and NeckProNiHNNCT04050761
A Study of Nivolumab in Patients With Head and Neck Cancer.
An observational study of Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and Neck, run by Bristol-Myers Squibb at 1 site in France.
Trial summary
A prospective real world evidence study of Nivolumab use in France in patient with recurrent or metastatic squamous cell carcinoma of the Head and Neck progressing on or after a platinum based therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and Neck
- What is being tested?
- Nivolumab
- How many people
- 502 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2019to 8 Jul 2024
- 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: adult patients who are at least 18 years of age with the diagnosis of Squamous Cell Carcinoma Head and Neck that the physician has already decided to initiate a treatment with nivolumab for the first time.
Who may be able to join
- Diagnosis of Squamous Cell Carcinoma Head and Neck (SCCHN) patients progressing on or after platinum-based therapy.
- 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 France) has already been taken
Who cannot join
- Patients previously treated with Nivolumab, Ipilimumab, or any other antibody or drug specifically targeting T-Cell Co stimulation or immune Checkpoint pathway.
- Patients currently included in an interventional clinical trial for their SCCHN.
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A French Prospective, Non-interventional Research ( NIR) of Nivolumab in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN) Progressing on or After a Platinum-based Therapy
A prospective real world evidence study of Nivolumab use in France in patient with recurrent or metastatic squamous cell carcinoma of the Head and Neck progressing on or after a platinum based therapy
- Being tested
- 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.
NivolumabBiological
Specified dose on Specific Days
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Participants diagnosed with recurrent or metastatic squamous cell carcinoma of the Head and Neck and whose physician has decided to initiate a treatment with Nivolumab for the first time for the treatment of SCCHN. Receives: Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 3 Years
Secondary outcomes (16)
Overall Survival within Sub groups
Measured: 3 year
Progression-free survival (PFS)
Measured: 3 Years
Overall response rate (ORR)
Measured: 3 years
Best overall response rate (BORR)
Measured: 3 years
Time to response (TTR)
Measured: 3 years
Duration of response (DOR)
Measured: 3 years
Incidents of Adverse Events (AEs)
Measured: 3 years
Incidents of immune-related Adverse Events
Measured: 3 years
Incident of treatment-related Adverse Events
Measured: 3 years
Number of socio-demographic characteristics in adult patients with SCCHN
Measured: 3 years
Number of clinical characteristics in adult patients with SCCHN
Measured: 3 Years
Number of treatment characteristics in adult patients with SCCHN
Measured: 3 Years
Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) Score
Measured: 3 Years
Quality of life of caregiver (CarGoQoL ) Score
Measured: 3 Years
Supportive Care Needs Survey for Partners and Caregivers (SCNS-P&C) Assessment score
Measured: 3 Years
European Quality of Life-5 Dimensions (EQ-5D) score
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start26 Jun 2019
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the 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
- Prospective
- Enrolment
- 502 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
- NCT04050761
- Sponsor's protocol ID
- CA209-9T9
- Acronym
- ProNiHN
- Status last verified
- Jun 2025
- First submitted
- 2 Aug 2019
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A French Prospective, Non-interventional Research ( NIR) of Nivolumab in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN) Progressing on or After a Platinum-based Therapy
- ClinicalTrials.gov ID
- NCT04050761
- Acronym / sponsor ID
- ProNiHN / CA209-9T9
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 8 Aug 2019 (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.
A prospective real world evidence study of Nivolumab use in France in patient with recurrent or metastatic squamous cell carcinoma of the Head and Neck progressing on or after a platinum based therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | – | Biological: NivolumabParticipants diagnosed with recurrent or metastatic squamous cell carcinoma of the Head and Neck and whose physician has decided to initiate a treatment with Nivolumab for the first time for the treatment of SCCHN. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients who are at least 18 years of age with the diagnosis of Squamous Cell Carcinoma Head and Neck that the physician has already decided to initiate a treatment with nivolumab for the first time.
Key inclusion criteria (3 listed)
- Diagnosis of Squamous Cell Carcinoma Head and Neck (SCCHN) patients progressing on or after platinum-based therapy.
- 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 France) has already been taken
Key exclusion criteria (3 listed)
- Patients previously treated with Nivolumab, Ipilimumab, or any other antibody or drug specifically targeting T-Cell Co stimulation or immune Checkpoint pathway.
- Patients currently included in an interventional clinical trial for their SCCHN.
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabSpecified dose on Specific Days | Biological | Monotherapy |
Primary outcome
Overall Survival
Time frame: 3 Years
16 secondary outcomes
Overall Survival within Sub groups
Time frame: 3 year
Progression-free survival (PFS)
Time frame: 3 Years
Overall response rate (ORR)
Time frame: 3 years
Best overall response rate (BORR)
Time frame: 3 years
Time to response (TTR)
Time frame: 3 years
Duration of response (DOR)
Time frame: 3 years
Incidents of Adverse Events (AEs)
Time frame: 3 years
Incidents of immune-related Adverse Events
Time frame: 3 years
Incident of treatment-related Adverse Events
Time frame: 3 years
Number of socio-demographic characteristics in adult patients with SCCHN
Time frame: 3 years
Number of clinical characteristics in adult patients with SCCHN
Time frame: 3 Years
Number of treatment characteristics in adult patients with SCCHN
Time frame: 3 Years
Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) Score
Time frame: 3 Years
Quality of life of caregiver (CarGoQoL ) Score
Time frame: 3 Years
Supportive Care Needs Survey for Partners and Caregivers (SCNS-P&C) Assessment score
Time frame: 3 Years
European Quality of Life-5 Dimensions (EQ-5D) score
Time frame: 3 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 2 Jul 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
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 Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and Neck, run by Bristol-Myers Squibb at 1 site in France.
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 3 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 2 Jul 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 France. 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: 3 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 2 Jul 2025.