Clinical trial NCT04050761: A Study of Nivolumab in Patients With Head and Neck Cancer.
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and Neck
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-08-08
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: 3 Years
Secondary outcomes:
measure: Overall Survival within Sub groups
timeFrame: 3 year
measure: Progression-free survival (PFS)
timeFrame: 3 Years
measure: Overall response rate (ORR)
timeFrame: 3 years
measure: Best overall response rate (BORR)
timeFrame: 3 years
measure: Time to response (TTR)
timeFrame: 3 years
measure: Duration of response (DOR)
timeFrame: 3 years
measure: Incidents of Adverse Events (AEs)
timeFrame: 3 years
measure: Incidents of immune-related Adverse Events
timeFrame: 3 years
measure: Incident of treatment-related Adverse Events
timeFrame: 3 years
measure: Number of socio-demographic characteristics in adult patients with SCCHN
timeFrame: 3 years
measure: Number of clinical characteristics in adult patients with SCCHN
timeFrame: 3 Years
measure: Number of treatment characteristics in adult patients with SCCHN
timeFrame: 3 Years
measure: Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) Score
timeFrame: 3 Years
measure: Quality of life of caregiver (CarGoQoL ) Score
timeFrame: 3 Years
measure: Supportive Care Needs Survey for Partners and Caregivers (SCNS-P&C) Assessment score
timeFrame: 3 Years
measure: European Quality of Life-5 Dimensions (EQ-5D) score
timeFrame: 3 Years
Other outcomes:
Locations:
city: Paris
country: France
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: