Observational Study of Nivolumab in Participants in Germany With Squamous Cell Carcinoma of the Head and Neck (SCCHN) Progressing on or After Platinum-Based Therapy

Active, not recruiting

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Diagnosis of Squamous cell carcinoma of the head and neck (SCCHN) and participants are progressing on or after platinum-based therapy, administered for locally advanced, metastatic or recurrent disease (Cohort 2: prior platinum-based therapy was administered for locally advanced disease in the adjuvant or primary setting, e.g. radiotherapy)
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 Germany) has already been taken

Exclusion Criteria

Current primary diagnosis of a cancer other than SCCHN, ie, a cancer other than SCCHN or cancer of unknown primary (CUP-syndrome) that requires systemic or other treatment, or has not been treated curatively (as per discretion of the investigator)
Previously treated with nivolumab and/or ipilimumab, an anti-PD-1, anti-programmed death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways (applicable for any indication)
Currently included in an interventional clinical trial for their SCCHN. Participants who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for Overall survival (OS) can be enrolled

Primary Outcome Measures

Name	Time	Method
Overall Survival	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to 5 years
Best overall response (BOR)	Up to 5 years
Overall Survival	Up to 5 years
Tumor response (Investigator assessed)	Up to 5 years
Description of management of participants with treatment-related adverse events (AEs)	Up to 5 years
Description of Severity of AEs	Up to 5 years
Description of management of AEs	Up to 5 years
Time to progression	Up to 5 years
Time to response (TTR)	Up to 5 years
Description of socio-demographic characteristics of participants	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	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	Up to 5 years
Overall Response Rate (ORR)	Up to 5 years
Best overall response rate (BORR)	Up to 5 years
Duration of response (DOR)	Up to 5 years
Description of clinical characteristics of participants	Up to 5 years
Description of incidence of AEs	Up to 5 years

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