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Head and Neck CancerPhase 2/3NCT04129320

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

A Phase 2/3 study testing enoblituzumab, MGA012 and MGD013 in people with Head and Neck Cancer and Squamous Cell Carcinoma of Head and Neck, run by MacroGenics.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
enoblituzumab, MGA012 and MGD013
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Oct 2019to Oct 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%)

Who cannot join

  • 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

About this study

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

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).

Read the 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).

Being tested
enoblituzumab, MGA012, MGD013
Keywords
SCCHN, head and neck, oropharyngeal, oral cavity, hypopharyngeal, laryngeal cancer, immunotherapy, PD-1, B7-H3, LAG-3
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Laryngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • enoblituzumabBiological

    Also called MGA271

    anti-B7-H3 antibody

  • MGA012Biological

    Also called INCMGA00012

    anti-PD-1 antibody

  • MGD013Biological

    PD-1 X LAG-3 bispecific DART protein

Study groups in NCT04129320
Study groupRoleWhat they receive
Experimental Arm 1ExperimentalEnoblituzumab plus MGA012
Receives: Biological: enoblituzumab; Biological: MGA012
Experimental Arm 2ExperimentalEnoblituzumab plus MGD013
Receives: Biological: enoblituzumab; Biological: MGD013

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

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

    Evaluation of adverse events and serious adverse events

    Measured: Up to 30 days after last dose of study drug

Secondary outcomes (9)

  1. 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.

    Measured: 2 years

  2. 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

    Measured: 2 years

  3. 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

    Measured: 2 years

  4. Immunogenicity (Module X)

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

    Measured: 2 years

  5. Immunogenicity (Module Y)

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

    Measured: 2 years

  6. Cmax (Module X)

    Maximum serum concentration of enoblituzumab and MGA012

    Measured: 2 years

  7. Ctrough (Module X)

    Trough serum concentration of enoblituzumab and MGA012

    Measured: 2 years

  8. Cmax (Module Y)

    Maximum serum concentration of enoblituzumab and MGD013

    Measured: 2 years

  9. Ctrough (Module Y)

    Trough serum concentration of enoblituzumab and MGD013

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2019
  2. Study startOct 2019 (estimated)
  3. Primary completionOct 2020 (estimated)
  4. Study completionOct 2022 (estimated)

Why it stopped: Change in study design

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Parallel study model refers to concurrent enrollment of non-randomized Modules X and Y.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04129320
Sponsor's protocol ID
CP-MGA271-05
Status last verified
Feb 2022
First submitted
14 Oct 2019
Last updated
8 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing enoblituzumab, MGA012 and MGD013 in people with Head and Neck Cancer and Squamous Cell Carcinoma of Head and Neck, run by MacroGenics.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (Modules X and Y) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04129320.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.

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