Table 4.

Running trials with immunotherapy in human papillomavirus related oropharyngeal carcinoma.

Name study	Design	Inclusion TNM 7th	Inclusion TNM 8th (for p16+ OPC)	Smoking	Primary endpoint
RTOG 3504 NCT02764593	4 arms: RT 70 Gy + weekly cisplatin + nivolumab 3-weekly cisplatin + nivolumab cetuximab + nivolumab nivolumab	OPC p16+: T1T2-Nb2N3; T4T3-N0N3, OPC p16-;OC, Larynx, HP:T1T2-N2aN3 or T3T4-Nx	OPC p16+: T1T2-N1N3 (excluding N1 with only ipsilateral LN); T3T4-Nx	OPC p16+: >10 PY or < 10 PY if T4 or N3	Dose limiting toxicity (DLT)
Keynote-412 NCT03040999	RT 70 Gy + 3-weekly cisplatin + Pembrolizumab vs. placebo	All locally advanced Head and neck squamous cell carcinoma's; independent of p16 status	All locally advanced Head and neck squamous cell carcinoma's; independent of p16 status	/	5Y-Event-free survival
CA209-9TM NCT03349710	Cisplatin eligible patient: RT 70 Gy + cisplatin + nivolumab vs. placebo Cisplatin ineligible patient: RT 70 Gy + Nivo vs. cetuximab	All locally advanced OPC, OC, HP, or larynx; independent of p16 status	All locally advanced OPC, OC, HP, or larynx; independent of p16 status	/	6Y-Event-free survival
CompARE CRUK/13/026	4 arms: RT 70 Gy (OTT: 7 weeks) + cisplatin RT 64 Gy (OTT: 5 weeks) + 3-weekly cisplatin RT 70 Gy (OTT: 7 weeks) + 3-weekly cisplatin + durvalumab surgery + RT + cisplatin	OPC p16+: T1T3-N2bN2c and all T4 or N3 OPC p16–: T1T4-N1N3 or T3T4-N0	OPC p16+: T1T3-N1N2 (excluding N1 with only ipsilateral LN); all T4 or N3	OPC p16+: T1T3-N2bN2c only included if more than 10 PY	Overall survival

RT, radiotherapy; OPC, Oropharyngeal carcinoma; OC, oral cavity; HP, Hypopharynx; PY, smoking pack years; 5 (6)Y, up to 5 (6) years after end of treatment; OTT, Overall Treatment Time; LN, lymph nodes.