Trials / Completed
CompletedNCT03480672
Postoperative aRCH With Cisplatin Versus aRCH With Cisplatin and Pembrolizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma
Postoperative Adjuvant Radiochemotherapy (aRCH) With Cisplatin (C) Versus aRCH With C and Pembrolizumab (P) in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC); Multicenter Randomized Phase II Study Within the German Interdisciplinary Study Group of German Cancer Society (IAG KHT); Pembro-Adjuvant-highRisk
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 211 (actual)
- Sponsor
- University of Leipzig · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-08-06
- Primary completion
- 2025-01-30
- Completion
- 2025-01-30
- First posted
- 2018-03-29
- Last updated
- 2026-02-17
Locations
16 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03480672. Inclusion in this directory is not an endorsement.