Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and Neck
Conditions
Brief 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
Interventions
BIOLOGICALNivolumab
Specified dose on Specific Days
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | 3 Years |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | 3 Years |
| Overall response rate (ORR) | 3 years |
| Best overall response rate (BORR) | 3 years |
| Time to response (TTR) | 3 years |
| Duration of response (DOR) | 3 years |
| Incidents of Adverse Events (AEs) | 3 years |
| Incidents of immune-related Adverse Events | 3 years |
| Overall Survival within Sub groups | 3 year |
| Number of socio-demographic characteristics in adult patients with SCCHN | 3 years |
| Number of clinical characteristics in adult patients with SCCHN | 3 Years |
| Number of treatment characteristics in adult patients with SCCHN | 3 Years |
| Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) Score | 3 Years |
| Quality of life of caregiver (CarGoQoL ) Score | 3 Years |
| Supportive Care Needs Survey for Partners and Caregivers (SCNS-P&C) Assessment score | 3 Years |
| European Quality of Life-5 Dimensions (EQ-5D) score | 3 Years |
| Incident of treatment-related Adverse Events | 3 years |
Countries
France
Outcome results
None listed