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Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

NCT03765918 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 714

Last updated 2026-05-12

Study results available
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Summary

This is a randomized, active-controlled, open-label study of pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.

Conditions

  • Head and Neck Neoplasms

Interventions

BIOLOGICAL

Pembrolizumab 200 mg

200 mg administered IV infusion on Day 1 of each 21-day cycle

RADIATION

Radiotherapy 60 Gray

Low risk participants administered 2 Gray in 30 fractions. Administered using intensity modulated radiation therapy.

RADIATION

Radiotherapy 66 Gray

High risk participants administered 2 Gray in 33 fractions. Administered using intensity modulated radiation therapy.

RADIATION

Radiotherapy 70 Gray

Participants with gross residual disease administered 2 Gray in 35 fractions. Administered using intensity modulated radiation therapy.

DRUG

Cisplatin 100 mg/m^2

100 mg/m\^2 administered by IV infusion on Day 1 of each 21-day cycle

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-17
Primary Completion
2024-07-25
Completion
2026-09-10
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Japan
  • Poland
  • Portugal
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

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Entities

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 NCT03765918 on ClinicalTrials.gov