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Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Study of Pembrolizumab combined with Ataluren in Patients with metastatic pMMR and dMMR colorectal cancer adenocarcinomas or metastatic dMMR endometrial carcinoma: the ATAPEMBRO study

This research study, called ATAPEMBRO, is looking into a new way to treat certain advanced cancers. It brings together two different cancer medications, pembrolizumab and ataluren, to see if they can work better when given together. The study is for people in the UK who have specific types of advanced bowel cancer (colon cancer) that has spread to other parts of the body, or advanced womb cancer (endometrial cancer) that has spread. It's a 'Phase 1 and 2' study, meaning scientists are first checking if the combination is safe and then looking to see if it helps patients. The hope is to find more effective treatments for these challenging cancers.

At a glance

Status
Ongoing, recruiting
Phase
Phase I and Phase II (Integrated)- Other
Sponsor
Amsterdam UMC
Enrolment target
47
Start
13 May 2024

What is this study about?

This clinical trial is exploring a new treatment approach for specific types of advanced cancer. The main goal is to see if combining two existing medications, called pembrolizumab and ataluren, can be safe and effective when used together. Pembrolizumab is a type of immunotherapy, which works by helping your own immune system fight cancer cells. Ataluren is a different kind of drug, and researchers believe it might enhance how pembrolizumab works in some cancers.

The study is specifically for people whose bowel cancer (colon cancer) or womb cancer (endometrial cancer) has spread to other parts of their body. The researchers are particularly interested in cases where the cancer cells have certain genetic features (referred to as pMMR or dMMR, which stands for 'mismatch repair proficient' or 'deficient'). Understanding these features is important because they can affect how well different treatments might work.

Because this is a 'Phase 1 and 2' study, it means it's an early stage of clinical research. In Phase 1, the main focus is on patient safety and finding the right dose of the combined drugs. If deemed safe, Phase 2 then looks at whether the treatment shows promising signs of working against the cancer. This kind of research is crucial for developing new and better ways to treat complex cancers in the future.

Key takeaways

  • This study combines two drugs, pembrolizumab and ataluren, for advanced bowel or womb cancer.
  • It's an early-stage study (Phase 1 and 2) to check safety and potential effectiveness.
  • Specifically targets advanced colon cancer and endometrial cancer that has spread.
  • Participation involves regular clinic visits, treatments, and health check-ups.
  • Potential benefits include access to a new treatment combination, but risks and side effects are possible.
  • You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or over. There is no upper age limit, so older adults can also take part.

Both men and women are welcome to participate. The study is looking for people who have advanced bowel cancer (colon cancer) or advanced womb cancer (endometrial cancer) that has spread to other parts of the body.

There will also be other specific health requirements and medical histories that the study doctors will review in detail to make sure the study is a good fit for you and safe for your participation. These details are important for your safety and to ensure the study provides clear results.

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. Are you 18 years old or older?
  2. Do you have advanced bowel cancer (colon cancer) that has spread?
  3. Do you have advanced womb cancer (endometrial cancer) that has spread?
  4. Are you able to attend regular clinic appointments and follow study instructions?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the two study drugs, pembrolizumab and ataluren, according to a specific schedule decided by the research team. This would involve regular visits to the clinic for treatments and check-ups.

During these visits, you would have various assessments. These typically include physical examinations, blood tests, and scans (like CT or MRI) to monitor your health and see how the treatment is affecting your cancer. You might also be asked to provide other samples, such as tissue biopsies, to help researchers understand more about your cancer and how the drugs are working.

The research team will closely follow your health throughout the study. The total duration of your participation would depend on how you respond to the treatment and your overall health, but you would be fully informed about the expected time commitment before joining.

Potential risks and benefits

Taking part in any clinical trial comes with potential benefits and risks. You might benefit from receiving a new combination therapy that could potentially be more effective than standard treatments for your cancer. However, there's no guarantee the treatment will work for everyone, and it might not be better than existing options. There are also potential side effects from the medications, which your doctor will explain in detail. You will be closely monitored for any reactions or side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Netherlands

Common questions

What kind of cancer is this study for?

This study is for people with advanced bowel cancer (colon cancer) or advanced womb cancer (endometrial cancer) that has spread to other parts of the body.

What are pembrolizumab and ataluren?

Pembrolizumab is a drug that helps your immune system fight cancer, and ataluren is another drug that researchers are testing to see if it makes pembrolizumab work better.

Will I definitely get the new combined treatment?

If you join the study, you would receive the combined treatment of pembrolizumab and ataluren, as this is an 'intervention' study testing this specific combination.

How long would I be in the study?

The length of time you'd be in the study depends on your response to treatment and your health. Your study doctor can give you more specific details.

Can I stop participating if I want to?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.

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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