Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Intervention: Spartalizumab; Investigator choice of chemotherapy
Intervention description: Spartalizumab was administered via intravenous infusion at a dose of 400 mg every 4 weeks (Q4W). Spartalizumab is a humanized anti-PD-1 IgG4 antibody which blocks the binding of PD1 to its ligands PD-L1 and PD-L2.; Commonly used chemotherapy as per investigator's choice. The dose and route of administration was the one described in each drug's label.
Intervention MeSH terms: Spartalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PDR001; nasopharyngeal cancer; moderately differentiated/undifferentiated; locally advanced; recurrent or metastatic NPC; after first- line platinum-based therapy

Summary:

      The purpose of this randomized controlled Phase II study is to assess the efficacy of PDR001
      versus investigator's choice of chemotherapy in patients with advanced nasopharyngeal
      carcinoma (NPC).

      By blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2, PDR001 leads to the
      activation of a T-cell mediated antitumor immune response.
    

Eligibility criteria:

        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.