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RecruitingPHASE3INTERVENTIONAL

A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

This research study is for adults diagnosed with a type of head and neck cancer that hasn't spread to other parts of the body, and cannot be removed by surgery. Participants have recently finished chemotherapy and radiotherapy. The main goal is to check if a new drug called Dostarlimab is safe and whether it works better than a dummy treatment (placebo) after their initial treatment. Half the participants will receive Dostarlimab, and the other half will receive the placebo. Researchers want to understand if Dostarlimab can help prevent the cancer from coming back or improve overall outcomes for people with this specific type of head and neck cancer.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
GlaxoSmithKline
Enrolment target
864
Start
21 Mar 2024
Estimated completion
26 Oct 2029

What is this study about?

This study is investigating a new treatment called Dostarlimab for a type of cancer that starts in the head or neck area. This specific cancer is called Squamous Cell Carcinoma, and in this study, it's advanced but hasn't spread throughout the body, and doctors haven't been able to remove it with surgery. The participants in this study would have already completed their initial treatment, which is usually a combination of chemotherapy and radiotherapy.

The main aim of this study is to see if Dostarlimab can help patients who have undergone their initial treatment. Doctors want to know if it's safe to use and if it can improve their chances of staying well compared to not receiving any additional active drug. By comparing Dostarlimab to a placebo (a dummy drug with no active ingredients), the researchers can understand the true effects of the new medicine.

This is a Phase 3 study, which means it's one of the final steps in testing a new treatment. It involves a larger group of people to confirm the safety and effectiveness seen in earlier, smaller studies. The results of this study will help decide if Dostarlimab could become a new standard treatment option for people with this type of head and neck cancer.

Key takeaways

  • This study tests a new drug, Dostarlimab, for head and neck cancer.
  • It's for adults who have finished chemotherapy and radiotherapy.
  • The study compares the new drug to a dummy treatment (placebo).
  • It aims to see if Dostarlimab is safe and helps prevent cancer from coming back.
  • You will be closely monitored if you take part.

Who may be eligible?

To join this study, you need to be an adult with a new diagnosis of head and neck squamous cell carcinoma in areas like your mouth, throat, or voice box. Your cancer must be locally advanced, meaning it hasn't spread to distant parts of your body, and surgery wasn't an option. You must have recently finished a specific chemotherapy and radiotherapy treatment.

Also, your doctors need to have taken a sample of your cancer before your chemotherapy and radiotherapy and found certain markers on it. Your overall health should be reasonably good, meaning you can perform most daily activities without too much difficulty, and your body's organs should be working well.

You cannot join if you've had other types of treatment for head and neck cancer before, or if your cancer started in different areas of your head or neck. If you've had certain severe side effects from similar drug treatments in the past, or unfortunately have more than one head and neck cancer, you also wouldn't be able to participate.

Quick self-check
  • Are you an adult with a new diagnosis of head and neck cancer?
  • Has your cancer been described as 'locally advanced' and not able to be removed by surgery?
  • Have you recently completed chemotherapy and radiotherapy for this cancer?
  • Are you generally well enough to go about most of your daily activities?
  • Have you not had severe reactions to similar immune-boosting drugs in the past?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be assigned by chance to receive either Dostarlimab or a placebo (a dummy treatment). Both will be given after your chemotherapy and radiotherapy have finished. You will have regular visits to the hospital for examinations, blood tests, and to receive your study treatment. The doctors and nurses will closely monitor your health and any side effects you might experience. These assessments are important to track how you are responding to the treatment and to ensure your safety. The exact number of visits, tests, and the total length of your participation will be explained in detail by the study team, but it will involve ongoing follow-up for a period after the treatment itself.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available, and you'll be closely monitored by a dedicated medical team. However, there are also potential risks; the new treatment might not work for you, or you could experience side effects, some of which might be serious. Because you might receive a placebo, you could also get no active treatment during the study. You will receive detailed information about all known and potential risks before you decide to join. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (277)

  • GSK Investigational Site
    Jonesboro, United States· Recruiting
  • GSK Investigational Site
    Los Angeles, United States· Recruiting
  • GSK Investigational Site
    Solvang, United States· Recruiting
  • GSK Investigational Site
    Stockton, United States· Recruiting
  • GSK Investigational Site
    Torrance, United States· Recruiting
  • GSK Investigational Site
    Farmington, United States· Recruiting
  • GSK Investigational Site
    New Haven, United States· Recruiting
  • GSK Investigational Site
    Washington D.C., United States· Recruiting
  • GSK Investigational Site
    St. Petersburg, United States· Recruiting
  • GSK Investigational Site
    Tamarac, United States· Withdrawn
  • GSK Investigational Site
    Atlanta, United States· Recruiting
  • GSK Investigational Site
    Fort Wayne, United States· Recruiting

+265 more sites — see the official record for the full list.

Common questions

What is Dostarlimab?

Dostarlimab is a new drug being tested to see if it helps the body's immune system fight cancer.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real drug but contains no active medicine. It helps compare the new drug's effects.

What does 'locally advanced' mean?

It means the cancer has grown into nearby tissues but hasn't spread to distant parts of the body.

Will I know if I'm getting the drug or the placebo?

No, this is usually 'blinded' so neither you nor your doctors will know, to ensure fair results.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care.

How to find out more

US GSK Clinical Trials Call Center

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of Dostarlimab vs Placebo After Chemoradiation in Ad…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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