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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)

NCT03040999 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 804

Last updated 2026-02-04

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-05
Primary Completion
2022-05-31
Completion
2024-08-21
FDA Drug
Yes

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

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03040999 on ClinicalTrials.gov