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Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04634825
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
MacroGenics

Tracking Information
First Submitted Date  ICMJE November 12, 2020
First Posted Date  ICMJE November 18, 2020
Last Update Posted Date May 18, 2022
Actual Study Start Date  ICMJE March 17, 2021
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2020)
  • Efficacy of enoblituzumab plus retifanlimab [ Time Frame: 28 months ]
    Investigator-assessed objective response rate (complete response [CR] or partial response [PR])
  • Safety of enoblituzumab plus tebotelimab [ Time Frame: 30 days after last dose ]
    Incidence of treatment-emergent adverse events
  • Efficacy of enoblituzumab plus tebotelimab [ Time Frame: 28 months ]
    Investigator-assessed objective response rate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2021)
  • Progression-free survival [ Time Frame: 28 months ]
    Time from the first dose date to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort
  • Disease-control rate [ Time Frame: 28 months ]
    Percentage of response-evaluable patients with CR, PR, or stable disease (SD) for at least 3 months, evaluated by cohort
  • Duration of response [ Time Frame: 28 months ]
    Time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort
  • Overall survival [ Time Frame: 28 months ]
    Time from the first dose date to the date of death from any cause, evaluated by cohort
  • Safety of enoblituzumab plus retifanlimab [ Time Frame: 30 days after last dose ]
    Incidence of treatment-emergent adverse events
  • Pharmacokinetics of enoblituzumab plus retifanlimab [ Time Frame: up to 42 weeks ]
    Serum concentration of enoblituzumab and retifanlimab
  • Pharmacokinetics of enoblituzumab plus tebotelimab [ Time Frame: up to 42 weeks ]
    Serum concentration of enoblituzumab and tebotelimab
  • Immunogenicity of enoblituzumab or retifanlimab [ Time Frame: 28 months ]
    Proportion of patients who develop anti-drug antibodies to enoblituzumab or retifanlimab
  • Immunogenicity of enoblituzumab or tebotelimab [ Time Frame: 28 months ]
    Proportion of patients who develop anti-drug antibodies to enoblituzumab or tebotelimab.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2020)
  • Progression-free survival [ Time Frame: 28 months ]
    Time from the first dose date to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort
  • Disease-control rate [ Time Frame: 28 months ]
    Percentage of response-evaluable patients with CR, PR, or stable disease (SD) for at least 3 months, evaluated by cohort
  • Duration of response [ Time Frame: 28 months ]
    Time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort
  • Overall survival [ Time Frame: 28 months ]
    Time from the first dose date to the date of death from any cause, evaluated by cohort
  • Safety of enoblituzumab plus retifanlimab [ Time Frame: 30 days after last dose ]
    Incidence of treatment-emergent adverse events
  • Pharmacokinetics of enoblituzumab plus retifanlimab [ Time Frame: up to 42 weeks ]
    Serum concentration of enoblituzumab and retifanlimab
  • Pharmacokinetics of enoblituzumab plus tebotelimab [ Time Frame: up to 42 weeks ]
    Serum concentration of enoblituzumab and tebotelimab
  • Immunogenicity of enoblituzumab plus retifanlimab [ Time Frame: 28 months ]
    Proportion of patients who develop anti-drug antibodies
  • Immunogenicity of enoblituzumab plus tebotelimab [ Time Frame: 28 months ]
    Proportion of patients who develop anti-drug antibodies
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
Official Title  ICMJE A Phase 2 Open-Label Trial to Evaluate Enoblituzumab in Combination With Retifanlimab or Tebotelimab in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Brief Summary This is a Phase 2 study of enoblituzumab combined with either retifanlimab or tebotelimab administered as first-line treatment to patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Enrollment into each cohort will occur independently in a non-randomized fashion, based on PD-L1 expression results. Patients may not crossover between cohorts.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Head and Neck Squamous Cell Carcinoma
Intervention  ICMJE
  • Biological: Enoblituzumab
    Anti-B7-H3 antibody
    Other Name: MGA271
  • Biological: Retifanlimab
    Anti-PD-1 antibody
    Other Name: INCMGA00012, MGA012
  • Biological: Tebotelimab
    PD-1 X LAG-3 bispecific DART molecule
    Other Name: MGD013
Study Arms  ICMJE
  • Experimental: Retifanlimab Cohort
    Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles
    Interventions:
    • Biological: Enoblituzumab
    • Biological: Retifanlimab
  • Experimental: Tebotelimab Cohort
    Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles
    Interventions:
    • Biological: Enoblituzumab
    • Biological: Tebotelimab
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 12, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2024
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven, recurrent or metastatic squamous cell carcinoma of the head and neck (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 if given as part of multimodal treatment for locally advanced disease)
  • Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Patients may not have a primary tumor site of upper esophagus, salivary gland, or nasopharynx (any histology)
  • Availability of formalin-fixed, paraffin embedded tumor specimen or contemporary biopsy for immunohistochemical evaluation of pharmacodynamic markers of interest
  • Willing to consent for baseline and on-treatment biopsy.
  • Performance status 0 or 1
  • Life expectancy of 6 months or more
  • Adequate end organ function
  • At least one radiographically measurable lesion
  • PD-L1 expression level that is either

    1. Positive (combined positive score [CPS] ≥ 1) for the retifanlimab cohort, or
    2. Negative (CPS < 1) for the tebotelimab cohort
  • Results available from human papilloma virus p16 status for oropharyngeal cancer
  • Acceptable laboratory results

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 prior to the first dose of study drug
  • Prior therapy with an anti-B7-H3, anti-PD-1, anti-PD-L1, or anti-LAG-3 agent
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: Global Trial Manager 301-251-5172 info@macrogenics.com
Listed Location Countries  ICMJE Australia,   Bulgaria,   Hungary,   Poland,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04634825
Other Study ID Numbers  ICMJE CP-MGA271-06
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 Not Provided
Current Responsible Party MacroGenics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE MacroGenics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ashley L. Ward, MD MacroGenics
PRS Account MacroGenics
Verification Date May 2022

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