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Completed

NCT Number: NCT04050761

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

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

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Key information

Conditions

Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Paris, Île-de-France Region, 75005, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Nivolumab

Biological

Specified dose on Specific Days

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: ProNiHN

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2019
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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