Treatment of p16 (HPV)-Positive Squamous Cell Carcinoma of the Tonsil at Advanced Stage

Clinical Scenario

This protocol applies to patients with squamous cell carcinoma of the tonsil (oropharynx) whose tumor is confirmed p16 (HPV)-positive and who present with advanced or recurrent disease — specifically those with recurrent, unresectable, or metastatic disease for whom surgery or radiotherapy is no longer a viable option.

Staging & Eligibility Criteria

• Primary site: base of tongue, tonsil, posterior pharyngeal wall, or soft palate
• HPV status confirmed positive by p16 immunohistochemistry (IHC) — required
• T0–2, N1 (single node >3 cm, or 2 or more ipsilateral nodes ≤6 cm), T1–2 N2, or T3 N0–2
• Also applicable at T0–3 N3 or T4 N0–3

Treatment Approach

First-line systemic therapy for this population is pembrolizumab-based — either as monotherapy where PD-L1 tumor expression meets the required threshold, or combined with platinum-based chemotherapy. The complete regimen selection criteria, eligibility conditions, and sequencing are available in the full protocol.