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

Primary Purpose

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

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

enoblituzumab

MGA012

MGD013

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring SCCHN, head and neck, oropharyngeal, oral cavity, hypopharyngeal, laryngeal cancer, immunotherapy, PD-1, B7-H3, LAG-3

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Experimental Arm 1

Experimental Arm 2

Arm Description

Enoblituzumab plus MGA012

Enoblituzumab plus MGD013

Outcomes

Primary Outcome Measures

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

Incidence of Adverse Events as assessed by CTCAE v 4.03 (Modules X and Y)

Evaluation of adverse events and serious adverse events

Secondary Outcome Measures

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.

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

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

Immunogenicity (Module X)

Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGA012

Immunogenicity (Module Y)

Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGD013

Cmax (Module X)

Maximum serum concentration of enoblituzumab and MGA012

Ctrough (Module X)

Trough serum concentration of enoblituzumab and MGA012

Cmax (Module Y)

Maximum serum concentration of enoblituzumab and MGD013

Ctrough (Module Y)

Trough serum concentration of enoblituzumab and MGD013

Full Information

NCT ID

NCT04129320

First Posted

October 14, 2019

Last Updated

February 4, 2022

Sponsor

MacroGenics

1. Study Identification

Unique Protocol Identification Number

NCT04129320

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Change in study design

Study Start Date

October 2019 (Anticipated)

Primary Completion Date

October 2020 (Anticipated)

Study Completion Date

October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MacroGenics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Arm 1

Arm Type

Experimental

Arm Description

Enoblituzumab plus MGA012

Arm Title

Experimental Arm 2

Arm Type

Experimental

Arm Description

Enoblituzumab plus MGD013

Intervention Type

Biological

Intervention Name(s)

enoblituzumab

Other Intervention Name(s)

MGA271

Intervention Description

anti-B7-H3 antibody

Intervention Type

Biological

Intervention Name(s)

MGA012

Other Intervention Name(s)

INCMGA00012

Intervention Description

anti-PD-1 antibody

Intervention Type

Biological

Intervention Name(s)

MGD013

Intervention Description

PD-1 X LAG-3 bispecific DART protein

Primary Outcome Measure Information:

Title

Overall Response Rate (Modules X and Y)

Description

Proportion of patients with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1

Time Frame

2 years

Title

Incidence of Adverse Events as assessed by CTCAE v 4.03 (Modules X and Y)

Description

Evaluation of adverse events and serious adverse events

Time Frame

Up to 30 days after last dose of study drug

Secondary Outcome Measure Information:

Title

Progression-free Survival - (Modules X and Y)

Description

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.

Time Frame

2 years

Title

Disease Control Rate - (Modules X and Y)

Description

Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment

Time Frame

2 years

Title

Duration of Response - (Modules X and Y)

Description

Time from the date of initial response to the date of first documented progression or death from any cause, whichever occurs first

Time Frame

2 years

Title

Immunogenicity (Module X)

Description

Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGA012

Time Frame

2 years

Title

Immunogenicity (Module Y)

Description

Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGD013

Time Frame

2 years

Title

Cmax (Module X)

Description

Maximum serum concentration of enoblituzumab and MGA012

Time Frame

2 years

Title

Ctrough (Module X)

Description

Trough serum concentration of enoblituzumab and MGA012

Time Frame

2 years

Title

Cmax (Module Y)

Description

Maximum serum concentration of enoblituzumab and MGD013

Time Frame

2 years

Title

Ctrough (Module Y)

Description

Trough serum concentration of enoblituzumab and MGD013

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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