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.

Other protocol-define inclusion/exclusion may apply.