Table 2.
Ongoing neoadjuvant immunotherapy clinical trials.
| NCT Number (Trial Name) | Phase | Protocol | Drugs | Primary Endpoint | Ref. |
|---|---|---|---|---|---|
| NCT03238365 | I | neoadjuvant | Nivolumab, Tadalafil | immune cell polarization (Th1/Th2; M1/M2) | |
| NCT03003637 (IMCISION) | IB/II | neoadjuvant | Nivolumab, Ipilimumab | tolerability, pathological response, hypoxia | (72) |
| NCT03174275 | II | adjuvant/neoadjuvant | Duravalumab, carboplatin, nab-paclitaxel | pCR rate | |
| NCT03721757 (NICO) | II | adjuvant/neoadjuvant | Nivolumab | DFS (12 months following surgery) | |
| NCT03107182 (OPTIMA-II) | II | neoadjuvant | Nivolumab, Nab-paclitaxcel, Carboplatin, 5-FU, Paclitaxcel | tumor shrinkage rate with DRR | |
| NCT03341936 | II | neoadjuvant | Nivolumab, Lirilumab | DFS | (73) |
| NCT03342911 | II | neoadjuvant | Nivolumab, Paclitaxcel, Carboplatin | pCR | |
| NCT03708224 | II | neoadjuvant | Atezolizumab, Tiragolumab, Tocilizumab | CD3+ T cells increase rate (≥ 40%) | |
| NCT03944915 (DEPEND) | II | neoadjuvant | Nivolumab | DRR | |
| NCT02641093 | II | adjuvant/neoadjuvant | Pembrolizumab, Cisplatin | safety and benefit of adding Pembro to SOC | (74, 75) |
| NCT04080804 | II | Neoadjuvant | Nivolumab, Relatlimab, Ipilimumab | safety, AEs rate | |
| NCT03765918 (Keynote-689) | III | adjuvant/neoadjuvant | Pembrolizumab, Cisplatin | MPR, event free survival (EFS) | (74, 75) |
| NCT03700905 (IMSTAR-HN) | III | adjuvant/neoadjuvant | Nivolumab, Ipilimumab | DFS (approximately 71 months) |
IMCISION, immunomodulation by the combination of ipilimumab and nivolumab in neoadjuvant to surgery in advanced or recurrent head and neck carcinoma; NICO, Neoadjuvant and adjuvant nivolumab as immune checkpoint inhibition in oral cavity cancer; OPTIMA-II, Chemotherapy and locoregional therapy trial for patients with head and neck cancer; DEPEND, De-escalation therapy for human Papillomavirus negative disease; IMSTAR-HN, Study of Nivolumab alone or in combination with Ipilimumab as immunotherapy vs standard follow-up in surgical resectable HNSCC after adjuvant therapy; pCR, pathological complete response; DFS, disease free survival; DRR, deep response rate; AE, adverse event; MPR, major pathological response; EFS, event free survival; PFS, progression free survival.