KEYNOTE-040, trial summary

A randomised clinical trial investigating the effect of pembrolizumab versus standard treatment in patients with recurrent or metastatic head and neck squamous cell cancer

Studied treatment	pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle
Control treatment	standard treatment (methotrexate, docetaxel or cetuximab) methotrexate 40 mg/m^2 IV (may be escalated to 60 mg/m^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m^2 IV on Day 1 of each 3- week cycle; or cetuximab 400 mg/m^2 IV loading dose on Day 1 and 250 mg/m^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m^2 on Days 1, 8, and 15 of each subsequent 3-week cycle

Patients	patients with recurrent or metastatic head and neck squamous cell cancer
Group sizes	-9 / -9

Blindness	open-design	Inclusion period
Follow-up duration		Centers
Lost to FU		geographical localisation
Primary endpoint	OS	Design

did not meet the primary endpoint of overall survival

Links

press release

blog

ClinicalTrial.gov record NCT02252042

Registering number	NCT02252042 (see trial on clinicaltrials.gov)
Code Name	MK-3475-040