BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)

Inclusion Criteria

• •Provide written, informed consent to participate in the study and follow the study procedures.
• •Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF).
• •Have histologically or cytologically-confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies.
• •* No prior systemic therapy for recurrent or metastatic disease.
• •* The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
• •* Patients may not have a primary tumor site of nasopharynx (any histology) and/or unknown primary.
• •Have measurable disease based on RECIST 1.1 as determined by the local site Investigator.
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• •Measure Description: GRADE - ECOG PERFORMANCE STATUS
• •0 - Fully active, able to carry on all pre-disease performance without restriction
• •1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work
• •2- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• •The tumor must have positive PD-L1 expression (i.e., CPS ≥1)