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