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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Gemeinschaftspraxis Haematologie Onkologie	Dresden	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Saarland University Hospital	Homburg	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Uaytwyrixzfciirrvxgtm Alrbcvpz	Augsburg	Germany
Uxiwgjaupzccixfoydnid Dqeibmrcuox Anl	Duesseldorf	Germany
Goomej Uixhraxcls Fhgxuwehb	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	16.09.2024

Trial locations

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.

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 ID:

2024-516536-10-00

Protocol code:

PeLeRad

NCT ID:

NCT05433116

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?