Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Biological: Enoblituzumab Biological: Retifanlimab Biological: Tebotelimab Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
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
Actual Study Start Date : March 17, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Retifanlimab Cohort
Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles
 Biological: Enoblituzumab
Anti-B7-H3 antibody
Other Name: MGA271

Biological: Retifanlimab
Anti-PD-1 antibody
Other Name: INCMGA00012, MGA012
Experimental: Tebotelimab Cohort
Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles
 Biological: Enoblituzumab
Anti-B7-H3 antibody
Other Name: MGA271

Biological: Tebotelimab
PD-1 X LAG-3 bispecific DART molecule
Other Name: MGD013


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Efficacy of enoblituzumab plus retifanlimab [ Time Frame: 28 months ]
    Investigator-assessed objective response rate (complete response [CR] or partial response [PR])

  2. Safety of enoblituzumab plus tebotelimab [ Time Frame: 30 days after last dose ]
    Incidence of treatment-emergent adverse events

  3. Efficacy of enoblituzumab plus tebotelimab [ Time Frame: 28 months ]
    Investigator-assessed objective response rate


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Overall survival [ Time Frame: 28 months ]
    Time from the first dose date to the date of death from any cause, evaluated by cohort

  5. Safety of enoblituzumab plus retifanlimab [ Time Frame: 30 days after last dose ]
    Incidence of treatment-emergent adverse events

  6. Pharmacokinetics of enoblituzumab plus retifanlimab [ Time Frame: up to 42 weeks ]
    Serum concentration of enoblituzumab and retifanlimab

  7. Pharmacokinetics of enoblituzumab plus tebotelimab [ Time Frame: up to 42 weeks ]
    Serum concentration of enoblituzumab and tebotelimab

  8. Immunogenicity of enoblituzumab or retifanlimab [ Time Frame: 28 months ]
    Proportion of patients who develop anti-drug antibodies to enoblituzumab or retifanlimab

  9. Immunogenicity of enoblituzumab or tebotelimab [ Time Frame: 28 months ]
    Proportion of patients who develop anti-drug antibodies to enoblituzumab or tebotelimab.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
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 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04634825


Contacts
Layout table for location contacts
Contact: Global Trial Manager 301-251-5172 info@macrogenics.com

Locations
Show Show 42 study locations
Sponsors and Collaborators
MacroGenics
Investigators
Layout table for investigator information
Study Director: Ashley L. Ward, MD MacroGenics
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: MacroGenics
ClinicalTrials.gov Identifier: NCT04634825    
Other Study ID Numbers: CP-MGA271-06
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site