Clinical Trials /

Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer

NCT04634825

Description:

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.

Related Conditions:
  • Hypopharyngeal Squamous Cell Carcinoma
  • Laryngeal Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CP-MGA271-06
  • NCT ID: NCT04634825

Conditions

  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Head and Neck Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
EnoblituzumabMGA271Retifanlimab Cohort
RetifanlimabINCMGA00012, MGA012Retifanlimab Cohort
TebotelimabMGD013Tebotelimab Cohort

Purpose

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

      This is an open-label, non-randomized study of approximately 80 patients. Enrollment into
      each cohort will occur independently, with 50 programmed cell death ligand 1 (PD-L1)-positive
      patients enrolled in the retifanlimab cohort, and 30 PD-L1-negative patients enrolled in the
      tebotelimab cohort.
    

Trial Arms

NameTypeDescriptionInterventions
Retifanlimab CohortExperimentalEnoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles
  • Enoblituzumab
  • Retifanlimab
Tebotelimab CohortExperimentalEnoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles
  • Enoblituzumab
  • Tebotelimab

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Efficacy of enoblituzumab plus retifanlimab
Time Frame:28 months
Safety Issue:
Description:Investigator-assessed objective response rate (complete response [CR] or partial response [PR])

Secondary Outcome Measures

Measure:Progression-free survival
Time Frame:28 months
Safety Issue:
Description:Time from the first dose date to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort
Measure:Disease-control rate
Time Frame:28 months
Safety Issue:
Description:Percentage of response-evaluable patients with CR, PR, or stable disease (SD) for at least 3 months, evaluated by cohort
Measure:Duration of response
Time Frame:28 months
Safety Issue:
Description: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
Measure:Overall survival
Time Frame:28 months
Safety Issue:
Description:Time from the first dose date to the date of death from any cause, evaluated by cohort
Measure:Safety of enoblituzumab plus retifanlimab
Time Frame:30 days after last dose
Safety Issue:
Description:Incidence of treatment-emergent adverse events
Measure:Pharmacokinetics of enoblituzumab plus retifanlimab
Time Frame:up to 42 weeks
Safety Issue:
Description:Serum concentration of enoblituzumab and retifanlimab
Measure:Pharmacokinetics of enoblituzumab plus tebotelimab
Time Frame:up to 42 weeks
Safety Issue:
Description:Serum concentration of enoblituzumab and tebotelimab
Measure:Immunogenicity of enoblituzumab plus retifanlimab
Time Frame:28 months
Safety Issue:
Description:Proportion of patients who develop anti-drug antibodies
Measure:Immunogenicity of enoblituzumab plus tebotelimab
Time Frame:28 months
Safety Issue:
Description:Proportion of patients who develop anti-drug antibodies

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:MacroGenics

Trial Keywords

  • SCCHN, head and neck, oropharyngeal, oral cavity, hypopharyngeal, laryngeal cancer, immunotherapy, PD-1, B7-H3, Lymphocyte Activation Gene-3 (LAG-3)

Last Updated

April 14, 2021