Clinical study - VADS

CA209-9T9 ProNiHN
VADS
Ouvert depuis le: 07.09.2020
Site: Paris
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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 PLATINUM-BASED THERAPY
Description de l'essai

This is a French, prospective, observational, multicenter cohort in adult patients diagnosed with SCCHN progressing on or after platinum-based therapy, who start a new systemic therapy with nivolumab for the first time, and are treated within the market authorization approval. It is mandatory that the treating physician·s decision to start treatment with nivolumab for SCCHN was taken independently and before the decision to invite the patient to participate in the study. Patients are to be enrolled into the study no later than the first dose of nivolumab treatment. Physicians will be asked to enroll eligible patients consecutively until the maximum inclusion threshold is reached. The enrollment period is anticipated to last approximately 2 years at study level. Patients will be followed for 3 years from Day 0 (ie, treatment initiation) until death, withdrawal of consent, loss of follow- up/record, or to the end of the study, whichever comes first. During the follow-up period, assessment schedules will be performed according to routine local clinical practice. Data entry in the electronic case report form (eCRF) will take place at Day 0, Week 6, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 36, (3 years after nivolumab initiation).