Combined Pembrolizumab and Lenvatinib after definitive Chemoradiation of locally advanced HNSCC in PD-L1 positive patients (CPS≥1)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516536-10-00

Acronym

PeLeRad

Enrollment

Registered

2024-09-18

Start date

2023-05-25

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

Locally advanced head and neck squamous cell carcinoma

Brief summary

Event-free survival (EFS) rate at 2 years: The disease progression will be evaluated radiologically (according to RECIST 1.1 criteria, investigator assessed). Death due to any case is an event. In addition, this endpoint will count salvage surgery at any time point for persistent or residual tumor as event if cancer is present in the pathological assessment. Further, neck dissection >20 weeks from the end of RCT will be an event if cancer is present in the pathological assessment

Interventions

DRUGLENVIMA 10 mg hard capsules

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) rate at 2 years: The disease progression will be evaluated radiologically (according to RECIST 1.1 criteria, investigator assessed). Death due to any case is an event. In addition, this endpoint will count salvage surgery at any time point for persistent or residual tumor as event if cancer is present in the pathological assessment. Further, neck dissection >20 weeks from the end of RCT will be an event if cancer is present in the pathological assessment	—

Measure

Time frame

—

Countries

Germany

Outcome results

None listed

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