All studies
Active not recruitingPHASE2INTERVENTIONAL

A Study of Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma

This research study is investigating a new treatment called tislelizumab, used alone or with other experimental medications, for a type of cancer known as head and neck squamous cell carcinoma. This is for patients whose cancer has returned or spread and cannot be cured with local treatments. The main goals are to find out how many people respond to the treatment (meaning their cancer might shrink or improve) and to understand any side effects they might experience. Tislelizumab works by helping the body's own immune system fight cancer cells. Around 160 patients will take part, with treatments given through a drip. The study aims to gather important information about this potential new approach to fighting head and neck cancer.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
BeiGene
Enrolment target
160
Start
21 Jul 2023
Estimated completion
28 May 2026

What is this study about?

This study is designed to explore new treatment options for a type of cancer called head and neck squamous cell carcinoma, specifically when the cancer has returned or spread and other local treatments aren't suitable. We're looking at a medicine called tislelizumab, both on its own and in combination with other new experimental drugs. The main questions we want to answer are: how effective are these treatments at reducing the cancer, and what side effects might patients experience?

Tislelizumab is a type of immunotherapy. It works by blocking a specific pathway in the body's immune system, which then allows your immune cells (especially called T-cells) to better recognise and attack the cancer cells. Combining tislelizumab with other medicines could potentially make this approach even more effective. This study will help us understand if these treatments can improve outcomes for patients with this type of head and neck cancer.

Ultimately, the goal is to find better ways to treat this condition. By carefully evaluating how these medicines work and what effects they have, both positive and negative, we hope to contribute to developing more effective therapies for patients in the future. It’s important to remember that these are investigational treatments, meaning they are still being studied.

Key takeaways

  • This study is testing new treatments for head and neck cancer that has returned or spread.
  • It uses an immunotherapy drug, tislelizumab, which boosts your immune system to fight cancer.
  • Treatments are given through a drip into a vein.
  • The study aims to see how well the treatments work and what side effects they have.
  • Participants will be closely monitored by the study team.

Who may be eligible?

To be considered for this study, you would need to have head and neck squamous cell carcinoma that has come back or spread and cannot be cured by local treatments like surgery or radiotherapy. The cancer must be in specific areas like your throat, mouth, or voice box. You should not have received any previous treatment for your cancer that has returned or spread, although prior treatment for earlier stages of the disease is allowed.

Your cancer cells must also show a certain level of a marker called PD-L1, which helps us understand how the treatment might work. You must also be generally well enough to participate, able to carry out your normal daily activities with little difficulty, and have a healthy enough blood count and organ function. If you are female and able to get pregnant, or male with a female partner who could get pregnant, you would need to agree to use effective birth control during and for several months after the study.

There are also some reasons why you might not be able to join. For example, if your cancer started in your nose (nasopharynx), skin, or salivary glands, or if it's not the squamous cell type. If you've previously had similar immunotherapy treatments, or if you have another active cancer or certain serious lung conditions, you would likely not be eligible. The study is open to both men and women aged 18 and older.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do you have head and neck squamous cell carcinoma that has come back or spread?
  2. Has your cancer started in your mouth, throat, or voice box (not nose, skin, or salivary glands)?
  3. Have you NOT had previous treatment for your cancer that has returned or spread (though prior treatment for early-stage disease is okay)?
  4. Are you generally well enough to go about your daily life easily?
  5. Are you willing to use effective birth control if needed?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to receive either tislelizumab on its own or tislelizumab combined with one of the other experimental medicines. This is like flipping a coin to decide your treatment group. The treatments will be given through a drip into a vein at regular, scheduled times. You will need to attend regular clinic visits for these infusions and for monitoring.

Throughout the study, the research team will carry out various tests and assessments to see how you are responding to the treatment and to check for any side effects. This will involve blood tests, scans, and physical examinations. You will continue to receive the study treatment for as long as it is helping you, as long as you don't experience too many side effects, or until you choose to stop participating. The precise duration of your involvement will depend on your individual response to treatment.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving an investigational treatment that could help to shrink your cancer or slow its growth. However, there's no guarantee that you will personally benefit. Like all medicines, the study treatments can have side effects, which could range from mild to serious. The research team will carefully monitor you for any side effects and manage them as best as possible. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (73)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Valkyrie Clinical Trials
    Verified postcode
    Los Angeles, United States
  • Stanford Medicine
    Verified postcode
    Stanford, United States
  • Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
    Verified postcode
    Lone Tree, United States
  • Florida Cancer Specialist Research Institute Lake Nona
    Verified postcode
    Orlando, United States
  • Florida Cancer Specialist Research Institute Panhandle
    Verified postcode
    Tallahassee, United States
  • University of Kentucky Markey Cancer Center
    Verified postcode
    Lexington, United States
  • Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
    Verified postcode
    Blacksburg, United States
  • Cancer Care Northwest
    Verified postcode
    Spokane Valley, United States
  • Northwest Cancer Specialist, Pc(Us Oncology Research)
    Verified postcode
    Vancouver, United States
  • Nepean Hospital
    Verified postcode
    Kingswood, Australia
  • North Shore Private Hospital
    Verified postcode
    St Leonards, Australia
  • Gold Coast Private Hospital
    Verified postcode
    Gold Coast, Australia

Common questions

What is head and neck squamous cell carcinoma?

It's a type of cancer that starts in the flat, scale-like cells in the head and neck area, such as the mouth, throat, or voice box.

What does 'recurrent or metastatic' mean?

Recurrent means the cancer has come back after treatment, and metastatic means it has spread to other parts of the body.

How does tislelizumab work?

It's a type of immunotherapy that helps your own immune system fight the cancer cells more effectively.

Will I know which treatment I'm getting?

You will be randomly assigned to one of the treatment groups, similar to drawing lots, so you might receive tislelizumab alone or combined with another drug.

How long will I take part in the study?

You will continue treatment for as long as it is benefiting you and you are not experiencing too many side effects, or until you decide to stop.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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