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

Last updated: February 4, 2022
Sponsor: MacroGenics
Overall Status: Trial Not Available

Phase

2/3

Condition

Nasopharyngeal Cancer

Carcinoma

Human Papilloma Virus (Hpv)

Treatment

N/A

Clinical Study ID

NCT04129320
CP-MGA271-05
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 theexception of systemic therapy completed > 6 months prior of given as part ofmultimodal 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

Exclusion Criteria:

  • Disease suitable for local therapy administered with curative intent
  • Progressive disease within 6 months of completion of curatively intended systemictreatment 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 offirst dose of study drug

Study Design

Study Start date:
October 01, 2019
Estimated Completion Date:
October 31, 2022

Study 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).