A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048)

PHASE3CompletedINTERVENTIONAL
Enrollment

882

Participants

Timeline

Start Date

March 19, 2015

Primary Completion Date

February 25, 2019

Study Completion Date

July 19, 2023

Conditions
Recurrent Head and Neck CancerMetastatic Head and Neck Cancer
Interventions
BIOLOGICAL

Pembrolizumab

Pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years).

DRUG

Cisplatin

Cisplatin 100 mg/m\^2 IV on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).

DRUG

Carboplatin

Carboplatin at a target AUC 5 IV on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).

DRUG

5-FU

5-FU 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).

BIOLOGICAL

Cetuximab

Cetuximab on Day 1 at a dose of 400 mg/m\^2 IV, and then 250 mg/m\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02358031 - A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048) | Biotech Hunter | Biotech Hunter