Overview

Enoblituzumab Plus MGA012 in Squamous Cell Carcinoma of the Head and Neck

Status:
Not yet recruiting
Trial end date:
2025-10-01
Target enrollment:
750
Participant gender:
All
Summary
This is a Phase 2/3, randomized, open-label study designed to evaluate safety and efficacy of enoblituzumab in combination with MGA012, with and without chemotherapy, in first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The study will be conducted in 2 modules, Module A (Phase 2) and Module B (Phase 3).
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
MacroGenics
Treatments:
Pembrolizumab
Criteria
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

- HPV test results available (positive and negative eligible)

- ECOG Performance status of 0 or 1

- Adequate end organ function

Exclusion Criteria:

- 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 randomization

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