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

NCT04129320 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: CP-MGA271-05
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Keywords

SCCHN; head and neck; oropharyngeal; oral cavity; hypopharyngeal; laryngeal cancer; immunotherapy; PD-1; B7-H3; LAG-3

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• Progression-free Survival - (Modules X and Y)

  2 years

• Disease Control Rate - (Modules X and Y)

  2 years

• Duration of Response - (Modules X and Y)

  2 years

• Immunogenicity (Module X)

  2 years

• Immunogenicity (Module Y)

  2 years

Study Arms (2)

Experimental Arm 1

EXPERIMENTAL

Enoblituzumab plus MGA012

Biological: enoblituzumab; Biological: MGA012

Experimental Arm 2

EXPERIMENTAL

Enoblituzumab plus MGD013

Biological: enoblituzumab; Biological: MGD013

Interventions

enoblituzumab BIOLOGICAL

anti-B7-H3 antibody

Also known as: MGA271

Experimental Arm 1; Experimental Arm 2

MGA012 BIOLOGICAL

anti-PD-1 antibody

Also known as: INCMGA00012

Experimental Arm 1

MGD013 BIOLOGICAL

PD-1 X LAG-3 bispecific DART protein

Experimental Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• MacroGenics: lead

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel study model refers to concurrent enrollment of non-randomized Modules X and Y.

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2022
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share