NCT03040999

Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)

A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 804 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
DRUG	Placebo	Normal saline or dextrose solution administered as an IV infusion Q3W
DRUG	Cisplatin	100 mg/m\^2 administered as an IV infusion Q3W
RADIATION	Accelerated Fractionation (AFX) Radiotherapy	70 Gray (Gy) given in 35 fractions over 6 weeks
RADIATION	Standard Fractionation (SFX) Radiotherapy	70 Gy given in 35 fractions over 7 weeks

Timeline

• Start date: 2017-04-05
• Primary completion: 2022-05-31
• Completion: 2024-08-21
• First posted: 2017-02-02
• Last updated: 2026-02-04
• Results posted: 2023-06-08

Locations

151 sites across 21 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, France, Germany, Israel, Italy, Japan, Netherlands, New Zealand, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study