USO 24007
A phase III randomized, open label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs. pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma (MCLA-158-CL03)
Disease Types: Head & Neck Cancer Research
Eligibility Requirements:
• Metastatic or locally recurrent HNSCC
• HNSCC primary tumor locations in oropharynx,
oral cavity, hypopharynx, and larynx are eligible
• No prior systemic therapy for metastatic disease
• Prior systemic therapy for LA disease is allowed if
PD was ≥6 months after last chemo dose
• Central testing for PD-L1, CPS ≥1, (OPC only:
p16)
• Measurable disease as defined by RECIST v1.1
• Tumor sample from metastatic or recurrent
primary site needs to be provided
• Life expectancy ≥ 12 weeks
Available at: