NCT04129320

Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck

A Phase 2/3 Open-Label Trial to Evaluate Enoblituzumab in Combination With MGA012 or MGD013 in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: MacroGenics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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).

Conditions

• Head and Neck Cancer
• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	enoblituzumab	anti-B7-H3 antibody
BIOLOGICAL	MGA012	anti-PD-1 antibody
BIOLOGICAL	MGD013	PD-1 X LAG-3 bispecific DART protein

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-10-01
• Completion: 2022-10-01
• First posted: 2019-10-16
• Last updated: 2022-02-08

Regulatory

• FDA-regulated drug study