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Combined Pembrolizumab and Lenvatinib after definitive Chemoradiation of locally advanced HNSCC in PD-L1 positive patients (CPS≥1)
EU CTIS ID: 2024-516536-10-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.