Nivolumab as Treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma After Failing 2 Lines or More Previous Chemotherapy

Nivolumab as Treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma After Failing 2 Lines or More Previous Chemotherapy

A phase II, open label, single arm, single agent study using nivolumab in patients who failed 2 or more lines of previous chemotherapy for recurrent/metastatic NPC (At least 1 line should include platinum based chemotherapy)

Inclusion Criteria:

• Recurrent or metastatic NPC incurable by local therapies and failed at least 2 lines of previous chemotherapy with at least 1 line including platinum based chemotherapy
• Measurable disease (RECIST 1.1)
• ECOG 2 or less
• Life expectancy greater than 3 months
• Adequate organ function
• (Provided tissue for PD-L1 biomarker analysis from a core or excisional biopsy Paired biopsy of baseline tissue at first diagnosis and for recurrence if possible) - optional but encouraged

Exclusion Criteria:

• Suitable for local therapy
• Did not have prior platinum chemotherapy
• Immunodeficiency; immunosuppressive treatment
• Anti-cancer monoclonal antibody treatment within 4 weeks prior to Day 1
• Other cancer treatment within 2 weeks prior to Day 1
• Other malignancies (some exceptions)
• CNS metastases; carcinomatous meningitis
• Active temporal lobe necrosis or on steroid treatment
• Autoimmune disease
• Active, non-infectious pneumonitis
• Active infection requiring systemic treatment
• Hepatitis