Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    80
  • sponsor
    MacroGenics
Updated on 30 May 2022
measurable disease
carcinoma
squamous cell carcinoma
primary tumor
oropharyngeal
carcinoma of oropharynx
metastatic squamous cell carcinoma

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.

Details
Condition Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma
Treatment Enoblituzumab, Retifanlimab, Tebotelimab
Clinical Study IdentifierNCT04634825
SponsorMacroGenics
Last Modified on30 May 2022

Eligibility

Yes No Not Sure

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
Positive (combined positive score [CPS] ≥ 1) for the retifanlimab cohort, or
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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