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

PHASE3CompletedINTERVENTIONAL
Enrollment

495

Participants

Timeline

Start Date

November 17, 2014

Primary Completion Date

May 15, 2017

Study Completion Date

August 15, 2022

Conditions
Head and Neck Squamous Cell Cancer
Interventions
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.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02252042 - Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040) | Biotech Hunter | Biotech Hunter