INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC

Exclusion Criteria

• •Has primary tumor site (any histology) of nasopharynx or salivary glands or occult primary site.
• •Has received prior systemic therapy (eg, prior chemo-, immune-, or biologic therapy) for locally advanced unresectable or metastatic HNSCC.
• •* Prior systemic therapy completed \>6 months prior to signing informed consent is allowed if given as part of multimodal treatment for locoregionally advanced disease with curative intent, and no PD/recurrence occurred within 6 months of its completion. Prior systemic immunotherapy in the locoregionally advanced disease with curative intent, including but not limited to anti-PD-(L)1 agents, is allowed if PD/recurrence occurred ≥12 months after its completion.
• •Has clinically active central nervous system metastases and/or carcinomatous meningitis.
• •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
• •Rapidly progressing disease or with features that may confer a high risk of tumor-associated hemorrhage or uncontrolled tumor pain.
• •Current or history of immune-related disease that required systemic treatment in past 2 years, except for replacement therapy.