At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized Trial of MK-3475 (Pembrolizumab) Versus Standard Treatment in Subjects With Recurrent or Metastatic Head and Neck Cancer
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab, Methotrexate, and 2 other interventions for Head and Neck Squamous Cell Cancer. Completed, enrolled 495 participants.
Detailed Summary
This is a study of pembrolizumab (MK-3475, KEYTRUDA®) versus standard treatment (methotrexate, docetaxel or cetuximab) for the treatment of recurrent or metastatic head and neck squamous cell cancer (HNSCC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment. The primary study hypothesis is that pembrolizumab treatment prolongs Overall Survival (OS) when compared to standard treatment.
Study Details
Timeline
Interventions
200 mg intravenous (IV) on Day 1 of each 3-week cycle.
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
75 mg/m\^2 IV on Day 1 of each 3- week cycle
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 250 mg/m\^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.