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

Phase 2

Active, not recruiting

• Conditions: Locally advanced head and neck squamous cell carcinoma

• Registration Number: 2024-516536-10-00
• Lead Sponsor: Universitaet Des Saarlandes, Universitaet Des Saarlandes

Brief Summary

To study efficacy of pembrolizumab/lenvatinib maintenance therapy versus pembrolizumab alone after definitive radiochemotherapy of locally advanced HNSCC to prolong the event-free survival (EFS) rate at 2 years.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-09-18
• Last Update Posted: 2024-09-18

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Locally advanced HNSCC stage III-IVB (TNM version 8)

histological confirmation

Baseline PD-L1 CPS≥1 (before radiochemotherapy)

Completed definitive radiochemotherapy (radiation dose ≥68Gy, with at least 200mg/m² BSA Cisplatin)

No progression during radiochemotherapy

ECOG PS 0 or 1

Exclusion Criteria

prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)

uncontrolled blood pressure (Systolic BP>140 mmHg or diastolic BP >90 mmHg) in spite of an optimized regimen of antihypertensive medication

distant metastases

tumor infiltration/perforation of the skin or cervical fistula (either at timepoint of study inclusion or prior to RCT)

known additional malignancy that is progressing or have required active treatment within the past 3 years

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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		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

Trial Locations

Locations (10)

Universitaetsklinikum Augsburg; 🇩🇪 Augsburg, Germany

Universitaetsklinikum Ulm AöR; 🇩🇪 Ulm, Germany

Universitaetsklinikum Erlangen AöR; 🇩🇪 Erlangen, Germany

Universitaetsklinikum Frankfurt AöR; 🇩🇪 Frankfurt Am Main, Germany

Universitaetsklinikum Giessen und Marburg GmbH; 🇩🇪 Giessen, Germany

Universitaetsklinikum Duesseldorf AöR; 🇩🇪 Duesseldorf, Germany

Universitaetsklinikum Regensburg AöR; 🇩🇪 Regensburg, Germany

Klinikum Chemnitz gGmbH; 🇩🇪 Chemnitz, Germany

Gemeinschaftspraxis Haematologie Onkologie; 🇩🇪 Dresden, Germany

Universitaet Des Saarlandes; 🇩🇪 Homburg, Germany

Universitaetsklinikum Augsburg

🇩🇪Augsburg, Germany

Klaus-Henning Kahl

Site contact

08214002542

KlausHenning.Kahl@uk-augsburg.de