Table 12.

Clinical studies in head and neck squamous cell carcinoma.

Patient group	Treatment	Participants (n)	Trial, ID	Outcomes	Reference
Recurrent or metastatic HNSCC	Nivolumab + ipilimumab	472	Phase 3, NCT02741570 (CheckMate 651)	ORR: 24.2% ORR in PD-L1 CPS ≥ 20: 34.1% Median OS: 13.9 months Median OS in PD-L1 CPS ≥ 20: 17.6 months Median PFS: 3.3 months Median PFS in PD-L1 CPS ≥ 20: 5.4 months Grade 3–4 AEs: 28.2%	Haddad et al., 2022 (143)
Recurrent or metastatic HNSCC (PD-L1-low/negative (TC<25%))	Durvalumab + tremelimumab	133	Phase 2, NCT02319044 (CONDOR)	ORR: 7.8% ORR in PD-L1 TC<1%: 7.4% ORR in PD-L1 TC<10%: 6.8% Median PFS: 2.0 months 6-month PFS rate: 13.7% Median OS: 7.6 months 12-month OS rate: 37% Grade 3–4 AE: 15.8%	Siu et al., 2019 (144)
Previously platinum treated recurrent or metastatic HNSCC	Durvalumab + tremelimumab	247	Phase 3, NCT02369874 (EAGLE)	ORR: 18.2% Median OS: 6.5 months 12-month OS: 30.4% 18-month OS: 21.0% 24-month OS: 13.3% Median PFS: 2.0 months Grade ≥3 TRAE: 16.3%	Ferris et al., 2020 (145)
Recurrent or metastatic HNSCC	Durvalumab + tremelimumab	413	Phase 3, NCT02551159 (KESTREL)	ORR overall: 21.8% ORR in PD-L1 TC ≥50%: 25.3% Median OS overall: 10.7 months Median OS in PD-L1 TC ≥50%: 11.2 months 12-month OS rate: 46.5% 18-month OS rate: 30.7% 24-month OS rate: 22.9% Median PFS overall: 2.8 months Median PFS in PD-L1 TC ≥50%: 2.8 months Grade 3–4 AEs: 19.1%	Psyrri et al., 2022 (146)

AE, adverse event; CPS, combined positive score; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; TC, tumor cells; TRAE, treatment-related adverse event.