Table 2.
Ongoing or planned trials on neoadjuvant immunotherapy in head and neck squamous-cell carcinoma including oral cavity tumours.
| Trial | Patient population | Neoadjuvant treatment | Adjuvant treatment | Status | Primary endpoint |
|---|---|---|---|---|---|
| NCT02488759 (CheckMate 358)41 | Neoplasms related to viral infections (incl. HPV+ head and neck cancers) | Nivolumab →S (single arm) | Specific to cancer type | Active, not recruiting | Safety, objective response rate, rate of surgery delay |
| NCT0229668442 | Any site (HPV–) platinum and anti-PD-1 for high-risk (+margins or ECE) | Pembrolizumab × 1→S | S→ RT ± C ± pembrolizumab × 6 | Ongoing | LRR and DFR at 1-year, rate of major pathologic response |
| NCT02919683 | Oral cavity only; platinum and RT considered post-operatively | Cohort 1: nivolumab → S cohort 2: nivolumab + ipilimumab × 1–2 →S | S → ±(C)RT | Active, not recruiting | ORR to treatment |
| NCT03021993 | Oral cavity only; stages T2–4 | Nivolumab × 3–4 →S | S→ ±(C)RT | Ongoing | Pathologic response rate |
| NCT03721757 | Oral cavity only; T1–4, N1–3 or any T3–4 N0 | Nivolumab × 1 →S | Nivolumab × 1 → (C)RT → nivolumab × 6 | Not yet recruiting | Disease-free survival |
| NCT03765918 | Stage III–IVA resectable | Pembrolizumab × 2 →S | S → RT ± C + pembrolizumab × 6 | Ongoing | Major pathological response, EFS |
| NCT02827838 | Oral cavity or oropharyngeal; platinum and RT considered postoperatively | Durvalumab × 2→S | S→ ±(C)RT | Ongoing | Changes in immune biomarkers |
| NCT03708224 | Stage III/IV resectable, HPV– | Atezolizumab × 2 →S | S→ ±(C)RT + atezolizumab × 12 | Ongoing | Effect on CD3+ T-cell infiltration, R0 resection rate |
| NCT02274155 | Stage III/IV resectable | Anti-OX40 antibody (MEDI6469) × 1–3→ S | S→ ±(C)RT | Active, not recruiting | Safety, feasibility of definitive surgical resection |
| NCT0212485043 | Any site; platinum and RT considered post-operatively | Cohort 1: motolimod + cetuximab → S Cohort 2: motolimod + cetuximab + nivolumab →S | S→ ±(C)RT | Terminated | Changes in immune biomarkers |
| NCT02002182 | HPV+ oropharyngeal, platinum and RT considered post-operatively | ADXS 11–001 vaccine →TORS | TORS → ±(C)RT | Active, not recruiting | Change in E6/7-specific CD8 + T-cell response |
| NCT04080804 | Stage III/IVA resectable | Nivolumab ± anti-LAG3 (relatlimab) ± ipilimumab →S | S→ ±(C)RT | Ongoing | Adverse events related to treatment |
C, chemotherapy; DFR, distant failure rate; ECE, extracapsular extension of lymph nodes; EFS, event-free survival; HPV, human papillomavirus; LRR, locoregional recurrence rate; ORR, overall response rate; PD-1, programmed cell death-1; S, surgery; RT, radiotherapy; TORS, transoral robotic resection.