Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Inclusion Criteria

• Histologically documented non-keratinizing locally advanced recurrent or metastatic NPC.
• Must be resistant to platinum-based chemotherapy (defined as progression on or after platinum-based chemotherapy given in the recurrent/metastatic setting).
• May have received at least 1 prior therapy for recurrent or metastatic disease, up to 2 prior systemic therapies.
• An archival tumor specimen or newly obtained tumor sample may be submitted at screening/baseline (a fresh tumor sample is preferred), unless agreed differently between Novartis and the Investigator.
• At least 1 measurable lesion (as per RECIST v1.1) progressing or new since last anti-tumor therapy.
• Prior treated brain or meningeal metastases must be without MRI evidence of progression for at least 8 weeks and off systemic steroids for at least 2 weeks prior to screening/baseline.
• Patient must be willing to undergo testing for human immunodeficiency virus (HIV) if not tested within the past 6 months. If HIV+ positive, patient will be eligible if: his/ her CD4+ count ≥ 300/μL; his/her viral load is undetectable; he/she is currently receiving highly active antiretroviral therapy (HAART).

Exclusion Criteria

• History of severe hypersensitivity reactions to other mAbs
• Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved asthma/atopy that is treated with broncho-dilators.
• Active HBV or HCV infections requiring therapy.
• Prior PD-1- or PD-L1-directed therapy or any therapeutic cancer vaccine.
• Patients receiving systemic treatment with any immunosuppressive medication.
• Use of any vaccines against infectious diseases (e.g. varicella, pneumococcus) within 4 weeks of initiation of study treatment.