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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04129320
Recruitment Status : Withdrawn (Change in study design)
First Posted : October 16, 2019
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
MacroGenics

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).

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Squamous Cell Carcinoma of Head and Neck Biological: enoblituzumab Biological: MGA012 Biological: MGD013 Phase 2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel study model refers to concurrent enrollment of non-randomized Modules X and Y.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2022


Arm Intervention/treatment
Experimental: Experimental Arm 1
Enoblituzumab plus MGA012
Biological: enoblituzumab
anti-B7-H3 antibody
Other Name: MGA271

Biological: MGA012
anti-PD-1 antibody
Other Name: INCMGA00012

Experimental: Experimental Arm 2
Enoblituzumab plus MGD013
Biological: enoblituzumab
anti-B7-H3 antibody
Other Name: MGA271

Biological: MGD013
PD-1 X LAG-3 bispecific DART protein




Primary Outcome Measures :
  1. Overall Response Rate (Modules X and Y) [ Time Frame: 2 years ]
    Proportion of patients with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1

  2. Incidence of Adverse Events as assessed by CTCAE v 4.03 (Modules X and Y) [ Time Frame: Up to 30 days after last dose of study drug ]
    Evaluation of adverse events and serious adverse events


Secondary Outcome Measures :
  1. Progression-free Survival - (Modules X and Y) [ Time Frame: 2 years ]
    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. Disease Control Rate - (Modules X and Y) [ Time Frame: 2 years ]
    Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment

  3. Duration of Response - (Modules X and Y) [ Time Frame: 2 years ]
    Time from the date of initial response to the date of first documented progression or death from any cause, whichever occurs first

  4. Immunogenicity (Module X) [ Time Frame: 2 years ]
    Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGA012

  5. Immunogenicity (Module Y) [ Time Frame: 2 years ]
    Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGD013

  6. Cmax (Module X) [ Time Frame: 2 years ]
    Maximum serum concentration of enoblituzumab and MGA012

  7. Ctrough (Module X) [ Time Frame: 2 years ]
    Trough serum concentration of enoblituzumab and MGA012

  8. Cmax (Module Y) [ Time Frame: 2 years ]
    Maximum serum concentration of enoblituzumab and MGD013

  9. Ctrough (Module Y) [ Time Frame: 2 years ]
    Trough serum concentration of enoblituzumab and MGD013



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129320


Sponsors and Collaborators
MacroGenics
Investigators
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Study Director: Fernanda I Arnaldez, MD MacroGenics
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Responsible Party: MacroGenics
ClinicalTrials.gov Identifier: NCT04129320    
Other Study ID Numbers: CP-MGA271-05
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MacroGenics:
SCCHN
head and neck
oropharyngeal
oral cavity
hypopharyngeal
laryngeal cancer
immunotherapy
PD-1
B7-H3
LAG-3
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site