For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Adult participants (at least 18 years of age at time of treatment decision)
- 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
Active, Not Recruiting
