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
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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