Eine Studie zu Nivolumab in Kombination mit Ipilimumab im Vergleich zur Standardtherapie (Extreme-Studienregime) als Erstlinientherapie bei Patienten mit wiederkehrendem oder metastasierendem Plattenepithelkarzinom des Kopf- und Halsbereichs

Biological: Nivolumab;Biological: Ipilimumab;Drug: Cetuximab/Erbitux;Drug: Cisplatin/Platinol;Drug: Carboplatin/Paraplatin;Drug: Fluorouracil/Adrucil

Inclusion Criteria:

- Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head
and neck (oral cavity, oropharynx, hypopharynx & larynx) that is not amenable to
curative therapy.

- No prior systemic cancer therapy for recurrent or metastatic disease (except if
chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).

- Measurable disease detected by imaging exam (CT or MRI).

- Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have
results from testing of HPV p16 status.

Exclusion Criteria:

- Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of
unknown primary, squamous cell carcinoma originating from skin and salivary glands or
non squamous histologies (eg. mucosal melanoma).

- No prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other
antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab
or EGFR inhibitors in any treatment setting.

- Participants with certain diseases such as active autoimmune disease, type I diabetes,
hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.

- Inadequate hematologic, renal or hepatic function.

Other protocol defined inclusion/exclusion criteria could apply