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

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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Recruitment Status : Withdrawn (Change in study design)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

Tracking Information
First Submitted Date  ICMJE October 14, 2019
First Posted Date  ICMJE October 16, 2019
Last Update Posted Date October 14, 2020
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2019)
  • Overall Response Rate - Module A [ Time Frame: 2 years ]
    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 - Module A and B [ Time Frame: Up to 30 days after last dose of study drug ]
    Evaluation of adverse events and serious adverse events
  • Overall Survival - Module A and B [ Time Frame: 2 years ]
    Time from randomization to death from any cause
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2020)
  • 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.
  • 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
  • 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
  • Immunogenicity (Module X) [ Time Frame: 2 years ]
    Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGA012
  • Immunogenicity (Module Y) [ Time Frame: 2 years ]
    Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGD013
  • Cmax (Module X) [ Time Frame: 2 years ]
    Maximum serum concentration of enoblituzumab and MGA012
  • Ctrough (Module X) [ Time Frame: 2 years ]
    Trough serum concentration of enoblituzumab and MGA012
  • Cmax (Module Y) [ Time Frame: 2 years ]
    Maximum serum concentration of enoblituzumab and MGD013
  • Ctrough (Module Y) [ Time Frame: 2 years ]
    Trough serum concentration of enoblituzumab and MGD013
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2019)
  • Immunogenicity - Module A [ Time Frame: 2 years ]
    Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGA012
  • Progression-free Survival - Module A and B [ 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.
  • Disease Control Rate - Module A and B [ 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
  • Duration of Response - Module A and B [ 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
  • Quality of Life QLQ-C30 - Module B [ Time Frame: 2 years ]
    EORTC overall Quality of Life questionnaire QLQ-C30 on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.
  • Quality of Life H&N-35 - Module B [ Time Frame: 2 years ]
    EORTC Quality of Life questionnaire H&N-35 for head and neck cancer patients on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Head and Neck Cancer
  • Squamous Cell Carcinoma of Head and Neck
Intervention  ICMJE
  • Biological: enoblituzumab
    anti-B7-H3 antibody
    Other Name: MGA271
  • Biological: MGA012
    anti-PD-1 antibody
    Other Name: INCMGA00012
  • Biological: MGD013
    PD-1 X LAG-3 bispecific DART protein
Study Arms  ICMJE
  • Experimental: Experimental Arm 1
    Enoblituzumab plus MGA012
    Interventions:
    • Biological: enoblituzumab
    • Biological: MGA012
  • Experimental: Experimental Arm 2
    Enoblituzumab plus MGD013
    Interventions:
    • Biological: enoblituzumab
    • Biological: MGD013
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 9, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2019)
750
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04129320
Other Study ID Numbers  ICMJE CP-MGA271-05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MacroGenics
Study Sponsor  ICMJE MacroGenics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Fernanda I Arnaldez, MD MacroGenics
PRS Account MacroGenics
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP