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CompletedNCT04050761ProNiHNUpdated Jul 2, 2025

A Study of Nivolumab in Patients With Head and Neck Cancer.

An observational study in Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and Neck, sponsored by Bristol-Myers Squibb. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-02.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
502
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and Neck
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.

This study's enrollment of 502 is above the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
502 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Biological: Nivolumab

Interventions

  • BiologicalNivolumab

    Specified dose on Specific Days

06

What researchers measure

Primary outcomes

  1. Overall Survival

    Time frame: 3 Years

Secondary outcomes

  1. Overall Survival within Sub groups

    Time frame: 3 year

  2. Progression-free survival (PFS)

    Time frame: 3 Years

  3. Overall response rate (ORR)

    Time frame: 3 years

  4. Best overall response rate (BORR)

    Time frame: 3 years

  5. Time to response (TTR)

    Time frame: 3 years

  6. Duration of response (DOR)

    Time frame: 3 years

  7. Incidents of Adverse Events (AEs)

    Time frame: 3 years

  8. Incidents of immune-related Adverse Events

    Time frame: 3 years

  9. Incident of treatment-related Adverse Events

    Time frame: 3 years

  10. Number of socio-demographic characteristics in adult patients with SCCHN

    Time frame: 3 years

  11. Number of clinical characteristics in adult patients with SCCHN

    Time frame: 3 Years

  12. Number of treatment characteristics in adult patients with SCCHN

    Time frame: 3 Years

  13. Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) Score

    Time frame: 3 Years

  14. Quality of life of caregiver (CarGoQoL ) Score

    Time frame: 3 Years

  15. Supportive Care Needs Survey for Partners and Caregivers (SCNS-P&C) Assessment score

    Time frame: 3 Years

  16. European Quality of Life-5 Dimensions (EQ-5D) score

    Time frame: 3 Years

07

Study locations

1 site
  • Local Institution - 0001
    Paris, Île-de-France Region 75005, France
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04050761
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Aug 8, 2019
Start date
Jun 26, 2019
Primary completion
Jul 8, 2024
Completion
Jul 8, 2024
Last update
Jul 2, 2025

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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