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Testing Drug Combinations with GSK4381562A, GSK6097608, GSK4428859 and Dostarlimab in Patients with PD-L1 Positive Head and Neck Cancer That Has Spread or Returned

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study looks at squamous cell carcinoma of the head and neck, which is a type of cancer that affects areas such as the throat, mouth, voice box, and surrounding tissues. The study focuses on cases where the cancer has either come back after treatment or has spread to other parts of the body, and where the tumor shows a specific marker called PD-L1. The treatments being tested include GSK4381562, GSK6097608, GSK4428859, and dostarlimab, which are all given through a vein as infusions. These medications work with the body's immune system to help fight cancer cells. The study will compare different combinations of these treatments to see how well they work against the cancer.

The purpose of the study is to evaluate how well these new combinations of immune system treatments work compared to dostarlimab alone in people with this type of cancer that shows the PD-L1 marker. The main measure of success will be looking at how many people experience either complete disappearance of their tumors or significant shrinking of their tumors during treatment. Participants will be assigned randomly to receive one of the treatment combinations, and the study will follow them for up to 24 months to track how their cancer responds.

During the study, participants will receive their assigned treatment through infusions into a vein, and doctors will regularly check how the tumors are responding using imaging scans and physical examinations. Tissue samples from the tumor will be needed to confirm that the cancer meets the study requirements and to check for the PD-L1 marker. The study is designed as an open-label trial, which means both the participants and their doctors will know which treatment is being given. This is a platform study using a master protocol, which means it is set up in a way that allows testing of multiple treatment combinations at the same time.

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 treatment phase begins

    Upon joining the study, your treatment will begin with one of the assigned medications. The study compares different immunotherapy combinations with a medication called dostarlimab.

    Immunotherapy is a type of treatment that helps your immune system fight cancer cells.

    The medication will be given through intravenous infusion, which means it will be delivered directly into your vein through a tube.

    The specific medication you receive, its dose, and how often you receive it will be determined by the study assignment.

  2. Step 2

    Regular treatment administration

    Your treatment will continue on a regular schedule throughout the study period.

    Each infusion session will take place at the study site.

    The treatment will be administered as an intravenous infusion or intravenous use, depending on the specific medication assigned to you.

  3. Step 3

    Disease monitoring and assessment

    During the study, your disease will be monitored regularly to see how it responds to treatment.

    This monitoring will include assessments based on RECIST 1.1, which is a standard method for measuring how tumors respond to treatment.

    The assessments will check for complete response (when the tumor disappears completely) or partial response (when the tumor shrinks significantly).

  4. Step 4

    Ongoing study participation

    Your participation in the study will continue as long as the treatment is beneficial and tolerated.

    Regular visits to the study site will be required for treatment administration and monitoring.

    Your physical condition will be assessed using the ECOG performance status, which is a scale that measures how the disease affects your daily living abilities.

  5. Step 5

    Study completion

    The study is expected to continue until approximately July 2027.

    Your individual participation may end earlier or later depending on how your disease responds to treatment and your overall health condition.

    Follow-up assessments may be conducted after your active treatment phase ends.

Who can join the trial?

12 criteria

  • You must have head and neck cancer (a type of cancer that starts in the mouth, throat, voice box, or related areas) that has been confirmed by examining tissue or cells under a microscope
  • Your cancer must be recurrent (came back after treatment) or metastatic (spread to other parts of the body) and cannot be cured with local treatments like surgery or radiation
  • You must not have received any previous treatment with drugs that go through your whole body for your cancer after it came back or spread, though radiation combined with chemotherapy completed more than 4 months before joining is allowed if it was part of your initial treatment
  • Your cancer must have started in one of these areas: the back of the throat near the tonsils, the mouth, the lower throat, or the voice box
  • Your cancer must not have started in the back of the nose area
  • You must have at least one tumor that can be measured using medical imaging scans
  • You must be able to perform normal daily activities with little to no help, rated as 0 or 1 on a scale that measures how well you can care for yourself
  • You must provide a sample of your tumor tissue taken at the time of or after your cancer was found to have come back or spread, preferably a fresh sample taken within 90 days, though older stored samples may be accepted in some cases
  • Your tumor must show the presence of a protein called PD-L1 (a substance on cancer cells that can be tested in the laboratory)
  • The tissue sample must be from a needle biopsy, surgical removal, or cut-out tissue, not from fine needle samples, bone marrow, or bone specimens
  • You can be male or female
  • You must be an adult

Who cannot join the trial?

3 criteria

  • The study information provided does not contain specific exclusion criteria, which are reasons why a patient cannot participate in the clinical trial
  • Without detailed exclusion criteria listed in the source data, it is not possible to provide specific conditions that would prevent participation in this study
  • Typically, exclusion criteria may include factors such as other serious medical conditions, certain medications being taken, or previous treatments, but these specific details are not available in the provided information
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Investigated drugs

Dostarlimab is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein called PD-1, which allows your body's immune system to better recognize and attack cancer cells in the head and neck area.

What is already known about the treatment

Dostarlimab – Dostarlimab is a medication given through an intravenous infusion (directly into a vein) that is currently approved and used in cancer treatment. It is primarily indicated for treating certain types of cancer, including recurrent or metastatic head and neck squamous cell carcinoma that shows PD-L1 protein expression. This medication works by blocking the PD-1 protein on immune cells, which prevents cancer cells from hiding from the body's immune system, allowing the immune system to recognize and attack the cancer more effectively. Dostarlimab belongs to a class of drugs called immune checkpoint inhibitors, which help the body's natural defenses fight cancer.

Investigated diseases

Head and Neck Neoplasms – Head and neck neoplasms are abnormal growths of tissue that develop in various areas of the head and neck region, including the mouth, throat, voice box, nose, and salivary glands. These neoplasms occur when cells in these areas begin to grow and multiply in an uncontrolled manner, forming masses or tumors. The disease can start in the thin, flat cells that line the moist surfaces inside the head and neck. As the condition progresses, the abnormal tissue growth may increase in size and can affect nearby structures. The growth pattern and speed of progression varies depending on the specific location and characteristics of the neoplasm. Some neoplasms may spread to lymph nodes in the neck or to other parts of the body over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503428-24-00Protocol code219885Estimated enrolment360 patientsSponsorGlaxosmithkline Research & Development Limited

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