Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck
Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck
This is an open-label study designed to evaluate safety and efficacy of enoblituzumab in
 combination with MGA012 or MGD013 in first-line treatment of patients with recurrent or
 metastatic squamous cell carcinoma of the head and neck (SCCHN).
The study will initially be conducted in 2 modules, Module X (enoblituzumab plus MGA012) and
 Module Y (enoblituzumab plus MGD013). Enrollment into Modules X and Y, with approximately 30
 patients each, will occur independently in a non-randomized fashion. Data from these modules
 will determine if further evaluation will occur in randomized Module A (Phase 2) and
 randomized Module B (Phase 3).
Inclusion Criteria:

 -  Histologically proven, recurrent or metastatic SCCHN not curable by local therapy

 -  No prior systemic therapy for SCCHN in the recurrent or metastatic setting (with the
 exception of systemic therapy completed > 6 months prior of given as part of
 multimodal treatment for locally advanced disease)

 -  Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx

 -  At least one radiographically measurable lesion

 -  HPV test results available (positive and negative eligible)

 -  ECOG Performance status of 0 or 1

 -  Adequate end organ function

 -  Positive PD-L1 expression level (CPS ≥ 1%)

 Exclusion Criteria:

 -  Disease suitable for local therapy administered with curative intent

 -  Progressive disease within 6 months of completion of curatively intended systemic
 treatment for locoregionally advanced SCCHN

 -  Radiation or other non-systemic therapy within 2 weeks of first dose of study drug

 -  Diagnosis of immunodeficiency, or use of immunosuppresive therapy within 14 days of
 first dose of study drug