Postoperative aRCH With Cisplatin Versus aRCH With Cisplatin and Pembrolizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT03480672 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2026-02-17

No results posted yet for this study

Summary

This trial evaluates the addition of pembrolizumab to standard postoperative adjuvant radiochemotherapy in the treatment of patients with locally advanced intermediate and high risk head and neck squamous cell carcinoma (HNSCC).

Conditions

  • HNSCC

Interventions

DRUG

Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

intravenous application, 12 months, in 3-week cycle (q3w) 200 mg

OTHER

adjuvant radiochemotherapy

adjuvant radiochemotherapy with cisplatin

Sponsors & Collaborators

  • University of Leipzig

    lead OTHER

Principal Investigators

  • Andreas Dietz, Prof. Dr. · University Leipzig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-06
Primary Completion
2025-01-30
Completion
2025-01-30

Countries

  • Germany

Study Locations

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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 NCT03480672 on ClinicalTrials.gov