Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria

• Confirmed squamous cell head and neck cancer
• Widespread (metastatic) disease, or returned after previous treatment (recurrent)
• Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and HPV [Human Papilloma Virus (oropharynx only)]
• Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)

Exclusion Criteria

• Previous treatment for metastatic or recurrent disease
• Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin
• Any non-squamous subtype
• Active autoimmune disease
• Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus
• Previous treatment with checkpoint inhibitor drugs
• Active CNS metastases or carcinomatous meningitis Other protocol-defined inclusion/exclusion criteria apply