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

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NCT02252042    
2nd line



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



EndpointX1N1X0N0TE95% CI ORR - -9 - -9 no data OS - -9 - -9 0,82[0,67; 1,01] PFS - -9 - -9 no data0,22,01,0

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