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Study of Pembrolizumab with Lenvatinib after Chemoradiation Treatment in Patients with Locally Advanced Head and Neck Cancer who are PD-L1 Positive

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with locally advanced head and neck squamous cell carcinoma, a type of cancer that develops in the cells lining the mouth, throat, or surrounding areas. The research examines two medications: pembrolizumab and lenvatinib. These medications will be given to patients after they have completed their initial cancer treatment with chemotherapy and radiation therapy.

The purpose of this research is to determine if using both pembrolizumab and lenvatinib together works better than using pembrolizumab alone in preventing cancer from returning. Pembrolizumab is given through an intravenous infusion into a vein, while lenvatinib is taken as oral capsules. The treatment period may last up to 47 weeks.

The study will include patients whose cancer cells have a specific characteristic called PD-L1, which is a protein found on some cancer cells. Patients will receive regular medical check-ups throughout the study period to monitor their health and evaluate how well the treatment is working. The medications being studied are designed to help the body's immune system fight cancer cells.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your diagnosis of locally advanced head and neck squamous cell carcinoma (stage III-IVB) has been confirmed through tissue examination

    Your tumor has tested positive for a marker called PD-L1 (CPS≥1)

    You have completed radiation therapy with a dose of at least 68Gy combined with chemotherapy using Cisplatin

  2. Step 2

    Treatment assignment

    You will be assigned to receive either:

    Option 1: Pembrolizumab (KEYTRUDA) alone, given through intravenous infusion

    Option 2: Pembrolizumab (KEYTRUDA) through intravenous infusion plus Lenvatinib (LENVIMA) capsules taken by mouth

  3. Step 3

    Treatment period

    The treatment will continue for up to 2 years

    Regular medical examinations will monitor your health status

    Imaging tests will be performed to check how your cancer responds to treatment

  4. Step 4

    Monitoring

    Your doctor will check for any signs of cancer progression using imaging scans

    If needed, additional examinations of your neck area may be performed

    Any side effects or health changes will be monitored throughout the treatment period

  5. Step 5

    Study completion

    The study is expected to end in October 2025

    Your doctor will discuss follow-up care options after the study ends

Who can join the trial?

9 criteria

  • You must be an adult (18 years or older)
  • You must have locally advanced head and neck cancer (stage III-IVB) that has been confirmed through tissue examination
  • Your tumor must test positive for a protein called PD-L1 with a score of 1 or higher before starting treatment
  • You must have completed combined radiation and chemotherapy treatment:
    • Radiation dose must have been at least 68 Gray
    • You must have received at least 200mg/m² of Cisplatin (a chemotherapy drug)
    • Your cancer must not have grown or spread during the radiation and chemotherapy treatment
    • You must have good physical function, being either:
      • Fully active and able to carry out all pre-disease activities without restriction, or
      • Unable to perform physically strenuous activities but able to carry out work of a light nature
      • Both men and women may participate

Who cannot join the trial?

14 criteria

  • History of other malignant tumors (cancers) in the past 5 years, except successfully treated non-melanoma skin cancer or cervical cancer
  • Known active brain metastases (cancer spread to the brain) or presence of brain/spinal cord disease
  • Autoimmune diseases requiring systemic treatment (conditions where the immune system attacks healthy cells)
  • History of organ transplantation
  • Active or chronic hepatitis B or C infection
  • HIV infection or AIDS
  • Uncontrolled high blood pressure (hypertension)
  • Serious heart conditions including heart attack in the past 6 months
  • Active bleeding problems or use of blood-thinning medications
  • Pregnant or breastfeeding women
  • Known allergies to the study medications
  • Participation in other clinical trials within the past 30 days
  • Mental conditions that could interfere with following study procedures
  • Any serious medical condition that could compromise patient safety during the study
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Investigated drugs

Pembrolizumab is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein called PD-L1, which can help your body's immune cells recognize and attack cancer cells more effectively. This medication is commonly used in the treatment of various types of cancer, including head and neck cancer. Lenvatinib is a targeted therapy medication that works by blocking the growth and spread of cancer cells. It specifically interferes with certain proteins that cancer cells need to grow and create new blood vessels. This medication helps to slow down or stop cancer growth. Chemoradiation is a combination treatment that includes both chemotherapy and radiation therapy given together. The chemotherapy makes cancer cells more sensitive to radiation treatment, while radiation therapy uses high-energy beams to destroy cancer cells.

What is already known about the treatment

  • Pembrolizumab

    A humanized monoclonal antibody administered via intravenous infusion that works by targeting the PD-1 receptor to enhance the immune system's ability to fight cancer cells. This immunotherapy medication is widely used in oncology and has shown significant effectiveness in treating various types of cancer, including head and neck squamous cell carcinoma. It belongs to the class of immune checkpoint inhibitors and works by blocking the interaction between PD-1 and its ligands, which helps restore T-cell activity against tumor cells.

  • Lenvatinib

    An oral medication taken in capsule form that functions as a multiple receptor tyrosine kinase inhibitor, targeting several proteins involved in tumor growth and blood vessel formation. This targeted therapy is approved for treating various types of cancer and works by blocking specific cellular pathways that cancer cells use to grow and spread. It belongs to the class of anti-angiogenic agents and helps prevent the formation of new blood vessels that supply tumors with nutrients and oxygen.

Investigated diseases

Head and Neck Squamous Cell Carcinoma - A type of cancer that begins in the flat cells that line the moist surfaces inside the head and neck regions. It typically develops in the mouth, throat, tongue, tonsils, or voice box. The disease usually starts when healthy cells develop changes in their DNA, causing them to grow uncontrollably and form a tumor. As the disease progresses, it can spread to nearby tissues and structures. The cancer cells can form masses in the affected areas, potentially affecting normal functions like speaking, swallowing, or breathing. This condition commonly appears first as persistent sores or lumps in the affected areas.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516536-10-00Protocol codePeLeRadEstimated enrolment50 patientsSponsorUniversitaet Des Saarlandes

sourced from the EU Clinical Trials Register and site verification

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