Phase 2/3 Trial of INBRX-106 + Pembrolizumab in 1L R/M HNSCC
Phase 2/3, Randomized Study of INBRX-106 Combined With Pembrolizumab Versus Pembrolizumab as First Line Treatment for Patients With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1 (CPS ≥20)
ClinicalTrials.gov
Key Eligibility Criteria:
+ Recurrent/metastatic head and neck squamous cell carcinoma considered incurable by local therapies
+ Primary tumor location of the oral cavity, oropharynx, hypopharynx, or larynx
+ Measurable disease by RECIST 1.1
+ Has tumor PD-L1 expression of CPS ≥20. Tumor tissue must be provided for PD-L1 biomarker analysis.
+ Prior curative-intent treatment for locoregionally advanced HNSCC allowed if progressive disease occurred >6 months (≥12 months if immunotherapy) after completion of treatment
+ No prior systemic treatment for locally advanced unresectable or metastatic HNSCC
+ No clinically active CNS metastases and/or carcinomatous meningitis
+ No rapidly progressing disease or disease with features that may confer a high risk of tumor-associated hemorrhage or uncontrolled tumor pain