An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
Trial Status: administratively complete
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.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04634825.
