Not recruiting

Study of Tislelizumab, Surzebiclimab, and LBL-007 for Patients with Recurrent or Metastatic Head and Neck Cancer

Fast replyInvestigationalNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a type of cancer known as Head and Neck Squamous Cell Carcinoma. This cancer affects areas such as the mouth, throat, and voice box. The study is exploring the use of a medication called Tislelizumab, which is given through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. Tislelizumab is being tested in combination with other investigational agents, which are new treatments that are still being studied and are not yet approved for general use. These investigational agents include BGB-A425 and LBL-007, both of which are also administered through intravenous infusion.

The purpose of this study is to assess the antitumor activity of Tislelizumab when used with these investigational agents. Participants in the study will receive these treatments to see how well they work in controlling the cancer. The study will involve multiple groups, with some participants receiving Tislelizumab alone and others receiving it in combination with one or more of the investigational agents. The study will monitor the response of the cancer to these treatments over a period of time, which can last up to 24 months.

Throughout the study, researchers will observe how the cancer responds to the treatment, including whether it shrinks or stops growing. They will also monitor the participants' overall health and any side effects they may experience. The study aims to provide valuable information on the effectiveness and safety of these treatments for people with recurrent or metastatic head and neck cancer, which means the cancer has returned or spread to other parts of the body.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be assessed to confirm eligibility. This includes having a confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma, with specific tumor locations such as the oropharynx, oral cavity, hypopharynx, or larynx.
The patient must not have received prior systemic therapy for recurrent or metastatic disease and must have a positive PD-L1 expression. Additionally, the patient should have at least one measurable lesion and meet specific health criteria.
Step 2
Treatment initiation
The patient will begin treatment with tislelizumab, administered as an intravenous infusion. This treatment may be combined with investigational agents, depending on the study arm assigned.
The dosage and frequency of administration will be determined by the study protocol and communicated to the patient by the healthcare team.
Step 3
Monitoring and assessments
Throughout the study, the patient will undergo regular monitoring to assess the response to treatment. This includes imaging studies and other tests to evaluate tumor response according to specific criteria.
The patient will also be monitored for any side effects or adverse events, which will be documented and managed according to established guidelines.
Step 4
Follow-up and conclusion
The study will continue until the estimated end date in March 2026, or until the patient completes the treatment protocol.
After completing the treatment, the patient will have follow-up visits to monitor long-term outcomes and any potential late effects of the treatment.

Who can join the trial?

9 criteria

Patients must have a confirmed diagnosis of **Head and Neck Squamous Cell Carcinoma** (HNSCC) that has come back or spread and cannot be cured with local treatments. The main tumor locations can be the oropharynx, oral cavity, hypopharynx, or larynx.
Patients should not have received prior systemic therapy for recurrent or metastatic HNSCC. Systemic therapy given as part of treatment for advanced disease is allowed if completed before joining the study.
Patients must have a positive **PD-L1 expression** with a Combined Positive Score (CPS) of 1 or more. PD-L1 is a protein that can affect the immune system's response to cancer.
Patients need to have at least one measurable lesion, which is a tumor that can be measured in size, as defined by specific guidelines (RECIST v1.1).
Patients must have an **Eastern Cooperative Oncology Group Performance Status** of 0 or 1, which means they are fully active or have some restrictions but can still carry out light work.
Patients should have adequate blood and organ function, shown by specific lab tests done within 7 days before the first dose of the study drug.
Patients must be willing to use a highly effective method of birth control during the study and for at least 120 days after the last dose of the study drug(s).
Both male and female patients are eligible to participate.
Patients from vulnerable populations can be included in the study.

Who cannot join the trial?

10 criteria

Patients with other types of cancer besides Head and Neck Squamous Cell Carcinoma cannot participate. This type of cancer affects the cells lining the mouth, nose, and throat.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
Patients who are not able to follow the study procedures or instructions cannot participate.
Patients who have certain medical conditions that might interfere with the study cannot participate. These conditions are usually specified by the study organizers.
Patients who are pregnant or breastfeeding cannot participate, as the study may involve medications that could affect the baby.
Patients who are currently participating in another clinical trial cannot participate, as this could interfere with the results of the study.
Patients who have had a recent major surgery or are recovering from a major surgery cannot participate, as this could affect their health during the study.
Patients who have a history of severe allergic reactions to medications cannot participate, as the study may involve new medications.
Patients who have an active infection that requires treatment cannot participate, as this could interfere with the study results.
Patients who have a history of drug or alcohol abuse cannot participate, as this could affect their ability to follow the study procedures.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Comite Entreprise Paul Papin
Verified
Angers, France
Fondazione I.R.C.C.S. Istituto Neurologico Besta
Verified
Milan, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy

Trial locations

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Investigated drugs

Tislelizumab
is a medication used in this trial to help the body's immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells, allowing the immune system to better target and destroy these cells.
Investigational Agents
are new treatments being tested in this trial to see how well they work with Tislelizumab. These agents are not yet approved for general use and are being studied to understand their effectiveness and safety in treating head and neck squamous cell carcinoma.

What is already known about the treatment

Tislelizumab – Tislelizumab is administered intravenously and is currently being studied in clinical trials as a potential treatment for recurrent or metastatic head and neck squamous cell carcinoma. It is an investigational medication, meaning it is still under research and not yet widely available in medical practice. The main therapeutic indication for tislelizumab is its use in cancer treatment, specifically targeting certain types of tumors. At the molecular level, tislelizumab works by blocking a protein called PD-1, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of drug that enhances the body's immune response against cancer.

Investigated diseases

Head and Neck Squamous Cell Carcinoma – This is a type of cancer that originates in the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It typically begins as a small, localized growth or sore that does not heal. As the disease progresses, it can invade nearby tissues and spread to lymph nodes in the neck. Symptoms may include a persistent sore throat, difficulty swallowing, and changes in voice. The disease can also cause swelling or lumps in the neck and unexplained weight loss. Early detection is crucial for managing the disease effectively.