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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and Neck

Intervention / Treatment
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* Biological: Nivolumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Monotherapy<br>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<br>* Specified dose on Specific Days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 3 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival within Sub groups |  | 3 year | 
| 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 | 
| Incident of treatment-related Adverse Events |  | 3 years | 
| 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 |