Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MacroGenics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
