This is a German, observational study in adult participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) progressing on or after platinum-based therapy, who start a new systemic therapy with nivolumab in 1st line (cohort 2) or ≥2nd line (cohort 1) for the first time, and are treated within the market authorization approval. Participants are to be enrolled into the study no earlier than the decision to initiate treatment with nivolumab and no later than the first dose of nivolumab treatment.
Study Type
OBSERVATIONAL
Enrollment
485
Local Institution - 0001
Leipzig, Germany
Overall Survival
Time frame: Up to 5 years
Overall Survival
Time frame: Up to 5 years
Progression-Free Survival (PFS)
Time frame: Up to 5 years
Time to progression
Time frame: Up to 5 years
Overall Response Rate (ORR)
Time frame: Up to 5 years
Best overall response rate (BORR)
Time frame: Up to 5 years
Best overall response (BOR)
Time frame: Up to 5 years
Tumor response (Investigator assessed)
Time frame: Up to 5 years
Time to response (TTR)
Time frame: Up to 5 years
Duration of response (DOR)
Time frame: Up to 5 years
Description of socio-demographic characteristics of participants
Time frame: Up to 5 years
Description of clinical characteristics of participants
Time frame: Up to 5 years
Description of management of participants with treatment-related adverse events (AEs)
Time frame: Up to 5 years
Description of incidence of AEs
Time frame: Up to 5 years
Description of Severity of AEs
Time frame: Up to 5 years
Description of management of AEs
Time frame: Up to 5 years
Description of participant-reported outcomes (PROs) and health-related quality-of-life (QoL) of participants using the Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) questionnaires
Time frame: Up to 5 years
Description of participant-reported outcomes (PROs) and health-related quality-of-life (QoL) of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires
Time frame: Up to 5 years
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