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

NCT ID: NCT04129320

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2022-10-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm 1

Enoblituzumab plus MGA012

Group Type: EXPERIMENTAL

enoblituzumab

Intervention Type: BIOLOGICAL

anti-B7-H3 antibody

MGA012

Intervention Type: BIOLOGICAL

anti-PD-1 antibody

Experimental Arm 2

Enoblituzumab plus MGD013

Group Type: EXPERIMENTAL

enoblituzumab

Intervention Type: BIOLOGICAL

anti-B7-H3 antibody

MGD013

Intervention Type: BIOLOGICAL

PD-1 X LAG-3 bispecific DART protein

Interventions

enoblituzumab

anti-B7-H3 antibody

Intervention Type: BIOLOGICAL

MGA012

anti-PD-1 antibody

Intervention Type: BIOLOGICAL

MGD013

PD-1 X LAG-3 bispecific DART protein

Intervention Type: BIOLOGICAL

Other Intervention Names

MGA271; INCMGA00012

Eligibility 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MacroGenics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CP-MGA271-05

Identifier Type: -

Identifier Source: org_study_id