A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500254-41-00

Acronym

MK-3475-689

Enrollment

180

Registered

2022-12-02

Start date

2018-12-13

Completion date

Unknown

Last updated

2025-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)

Brief summary

Event-free Survival (EFS)

Detailed description

Major Pathological Response (mPR), Overall Survival (OS), Pathological Complete Response (pCR), Change From Baseline in Global Health Status/Quality of Life Scale (GHS/QoL), Change From Baseline in Global Health Status/Physical Functioning Scales, Change from Baseline in Swallowing, Speech, and Pain Symptoms, Percentage of Participants Experiencing an Adverse Event (AEs), Percentage of Participants Discontinuing Study Drug Due to AEs

Interventions

DRUGCISPLATIN

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Event-free Survival (EFS)	—

Secondary

Measure	Time frame
Major Pathological Response (mPR), Overall Survival (OS), Pathological Complete Response (pCR), Change From Baseline in Global Health Status/Quality of Life Scale (GHS/QoL), Change From Baseline in Global Health Status/Physical Functioning Scales, Change from Baseline in Swallowing, Speech, and Pain Symptoms, Percentage of Participants Experiencing an Adverse Event (AEs), Percentage of Participants Discontinuing Study Drug Due to AEs	—

Measure

Time frame

—

Countries

Austria, Belgium, France, Germany, Hungary, Ireland, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026