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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04129320
• Other study ID #: CP-MGA271-05
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: October 2019
• Est. completion date: October 2022

Study information

• Verified date: February 2022
• Source: MacroGenics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2022
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• enoblituzumab
anti-B7-H3 antibody
• MGA012
anti-PD-1 antibody
• MGD013
PD-1 X LAG-3 bispecific DART protein

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MacroGenics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (Modules X and Y)	Proportion of patients with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1	2 years
Primary	Incidence of Adverse Events as assessed by CTCAE v 4.03 (Modules X and Y)	Evaluation of adverse events and serious adverse events	Up to 30 days after last dose of study drug
Secondary	Progression-free Survival - (Modules X and Y)	Time from start of study treatment to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.	2 years
Secondary	Disease Control Rate - (Modules X and Y)	Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment	2 years
Secondary	Duration of Response - (Modules X and Y)	Time from the date of initial response to the date of first documented progression or death from any cause, whichever occurs first	2 years
Secondary	Immunogenicity (Module X)	Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGA012	2 years
Secondary	Immunogenicity (Module Y)	Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGD013	2 years
Secondary	Cmax (Module X)	Maximum serum concentration of enoblituzumab and MGA012	2 years
Secondary	Ctrough (Module X)	Trough serum concentration of enoblituzumab and MGA012	2 years
Secondary	Cmax (Module Y)	Maximum serum concentration of enoblituzumab and MGD013	2 years
Secondary	Ctrough (Module Y)	Trough serum concentration of enoblituzumab and MGD013	2 years