NCT02252042

Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040)

A Phase III Randomized Trial of MK-3475 (Pembrolizumab) Versus Standard Treatment in Subjects With Recurrent or Metastatic Head and Neck Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 495 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	200 mg intravenous (IV) on Day 1 of each 3-week cycle.
DRUG	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
DRUG	Docetaxel	75 mg/m\^2 IV on Day 1 of each 3- week cycle
BIOLOGICAL	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 250 mg/m\^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.

Timeline

• Start date: 2014-11-17
• Primary completion: 2017-05-15
• Completion: 2022-08-15
• First posted: 2014-09-29
• Last updated: 2023-07-17
• Results posted: 2018-08-13

Regulatory

• FDA-regulated drug study