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Active not recruitingPHASE2INTERVENTIONAL

A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

This important study is investigating a new medication, dostarlimab, for people diagnosed with a particular kind of early-stage rectal cancer that hasn't spread and hasn't been treated yet. This type of cancer is known as dMMR/MSI-H. The main goal is to find out if dostarlimab by itself can be an effective treatment. If it works well, it could mean that patients might not need to go through traditional treatments like chemotherapy, radiation, or surgery. The research will carefully watch if dostarlimab shrinks the tumour completely. If it does, doctors will then closely monitor patients without further intense treatments to see if the cancer stays away. This trial aims to offer a gentler treatment path for some patients.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
GlaxoSmithKline
Enrolment target
154
Start
03 Apr 2023
Estimated completion
11 Oct 2029

What is this study about?

This study is exploring a new way to treat certain rectal cancers that haven't spread to other parts of the body and haven't been treated before. The treatment involves a medication called dostarlimab. Rectal cancer is a type of cancer that starts in the last part of the large bowel. This specific study focuses on a particular kind of rectal cancer identified by special tests as 'dMMR' or 'MSI-H'. These terms refer to certain genetic features of the cancer cells.

Traditionally, treatment for this type of rectal cancer often involves a combination of chemotherapy, radiation, and surgery. However, these treatments can be tough on the body and have side effects. Researchers want to see if dostarlimab alone can be strong enough to make the cancer disappear without needing these other treatments. If it can, it would mean a much less intensive experience for patients.

If a patient's cancer completely disappears after taking dostarlimab, they will then be closely watched by their doctors. This careful monitoring, without further heavy treatments, is called 'non-operative management'. The hope is that dostarlimab can successfully remove the cancer and keep it from coming back, offering a simpler and potentially life-changing option for those who qualify.

Key takeaways

  • This study explores a new drug (dostarlimab) for a specific type of early rectal cancer.
  • It aims to see if patients can avoid traditional treatments like chemotherapy and surgery.
  • The focus is on 'dMMR/MSI-H' rectal cancer that hasn't spread or been treated before.
  • Success means close monitoring instead of more intense therapies.
  • Participation involves receiving the drug and regular check-ups.
  • You can stop participating at any time.

Who may be eligible?

To be considered for this study, you would need to have rectal cancer that is in its early stages (Stage II or III) and has not spread to distant parts of your body. Doctors would also need to be able to see and assess your cancer using scans and a camera test (endoscopy). Crucially, tests on your cancer cells must show that it is a specific type, known as 'dMMR' or 'MSI-H'. You must not have had any previous treatment for this rectal cancer, such as radiation, chemotherapy, or surgery.

There are also some reasons why you might not be able to join. For example, if your cancer has already spread to other organs (known as metastatic disease), or if you have had certain lung conditions in the past. Also, if you've had severe allergic reactions to similar types of medicines or have certain active autoimmune diseases that need ongoing treatment, you likely wouldn't be able to participate. The study also cannot include individuals who have recently had or need an organ or stem cell transplant from a donor.

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 I have Stage II or III rectal cancer?
  2. Has my cancer been tested as 'dMMR' or 'MSI-H'?
  3. Have I received *no* previous treatment for my rectal cancer (no surgery, chemo, or radiation)?
  4. Has my cancer *not* spread to other parts of my body?
  5. Do I have certain long-term lung conditions, severe allergies, or active autoimmune diseases?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study drug, dostarlimab. After treatment, doctors will closely monitor your condition. This involves going for regular check-ups, scans, and other tests to see how you are doing and to ensure the cancer has remained gone. The study aims to see if you can avoid chemotherapy, radiation, and surgery. While the total duration isn't specified, these types of studies typically involve regular visits during treatment and then follow-up visits for several years.

Potential risks and benefits

Potential benefits of taking part could include receiving an innovative treatment that might help you avoid surgery, chemotherapy, and radiation, which can have significant side effects. You would also be closely monitored by a dedicated medical team. However, as with any medical treatment, there are potential risks and side effects from dostarlimab, which your doctor would discuss in detail. There's also the chance that the treatment might not work for you. Remember, joining a clinical trial is always 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 (42)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • GSK Investigational Site
    Verified postcode
    Los Angeles, United States
  • GSK Investigational Site
    Verified postcode
    Albuquerque, United States
  • GSK Investigational Site
    Verified postcode
    New York, United States
  • GSK Investigational Site
    Verified postcode
    Pittsburgh, United States
  • GSK Investigational Site
    Verified postcode
    Nashville, United States
  • GSK Investigational Site
    Verified postcode
    Dallas, United States
  • GSK Investigational Site
    Verified postcode
    Richmond, United States
  • GSK Investigational Site
    Verified postcode
    Ottawa, Canada
  • GSK Investigational Site
    Verified postcode
    Toronto, Canada
  • GSK Investigational Site
    Verified postcode
    Montreal, Canada
  • GSK Investigational Site
    Verified postcode
    Sherbrooke, Canada
  • GSK Investigational Site
    Verified postcode
    Besançon, France

Common questions

What is 'dMMR/MSI-H' rectal cancer?

It's a specific type of rectal cancer identified by genetic tests. If your cancer has these features, it might respond well to certain new treatments like the one in this study.

What is dostarlimab?

Dostarlimab is a type of medicine known as immunotherapy, which works by helping your body's immune system fight cancer cells.

Will I still need surgery or chemotherapy if I join this study?

The main goal of this study is to see if dostarlimab alone can help you avoid these treatments. If your cancer completely disappears, you would be closely monitored instead.

Are there side effects to dostarlimab?

Yes, all medications can have side effects. Your study doctor will explain any potential side effects of dostarlimab in detail.

How long does the study last?

The exact total duration isn't specified, but clinical trials involve a treatment period and then a follow-up period, which can last several years.

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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