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

MacroGenics

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Squamous Cell Carcinoma of Head and Neck; Head and Neck Cancer

Treatments: Biological: MGD013; Biological: MGA012; Biological: enoblituzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04129320

CP-MGA271-05

Details and patient eligibility

About

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).

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Experimental Arm 1

Experimental group

Description:

Enoblituzumab plus MGA012

Treatment:

Biological: enoblituzumab

Biological: MGA012

Experimental Arm 2

Experimental group

Description:

Enoblituzumab plus MGD013

Treatment:

Biological: enoblituzumab

Biological: MGD013