Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

PEMBROLIZUMAB IN MMR-PROFICIENT METASTATIC COLORECTAL CANCER PHARMACOLOGICALLY PRIMED TO TRIGGER DYNAMIC HYPERMUTATION STATUS - THE ARETHUSA TRIAL

This research, called the ARETHUSA trial, is for people with advanced bowel cancer that has spread to other parts of the body and hasn't responded to standard treatments. It's investigating if a specific chemotherapy drug, temozolomide, can make other treatments more effective. The idea is that temozolomide might change the cancer cells in a way that makes them more visible to the body's immune system, allowing an immunotherapy drug called pembrolizumab (Keytruda) to work better. We want to see how many people respond to this combination and how safe it is. The study is particularly looking for people with a specific type of bowel cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ifom Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets

Enrolment target

822

Start

09 Jan 2025

Metastatic colorectal cancer

What is this study about?

This study, called ARETHUSA, is looking for better ways to treat bowel cancer that has spread (metastatic colorectal cancer) and hasn't improved with regular treatments. The main treatment being tested is a medicine called pembrolizumab, also known as Keytruda. This type of drug helps your body's immune system fight cancer.

However, for pembrolizumab to work well, sometimes the cancer cells need a little 'nudge' to make them more noticeable to the immune system. This study is testing if a chemotherapy drug called temozolomide can provide that nudge. The idea is that temozolomide might create more changes within the cancer cells, making them easier for pembrolizumab to target. We want to see how well this combined approach works in shrinking the cancer or stopping it from growing, and how safe it is for patients.

This is a 'Phase II' study, which means it's an earlier stage of research. It's designed to see if this new treatment method shows enough promise to be studied in larger trials later on. The researchers will be closely watching how patients respond, how long they stay well, and their overall health. The results from this study will help doctors understand whether this combination could be a useful option for people living with advanced bowel cancer.

Key takeaways

This study evaluates a new treatment combination for advanced bowel cancer.
It combines chemotherapy (temozolomide) with immunotherapy (pembrolizumab).
The aim is to make immunotherapy more effective for specific cancer types.
It's for people whose cancer hasn't responded to standard treatments.
Participation involves regular hospital visits for treatment and monitoring.
Benefits include access to new treatments, but risks of side effects exist.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or older, and have advanced bowel cancer that has spread to other parts of your body. Your cancer would also need to have certain characteristics that doctors can check with tests, for example, it shouldn't have responded to previous standard treatments.

Doctors will perform special tests on your cancer tissue. They will be looking for specific features like a 'RAS mutation' and checking something called 'MMR proficiency'. They will also look at whether your cancer cells have a 'MGMT-negative' status. These are important details that help the researchers decide if this particular treatment might be suitable for you.

Both men and women can take part in this study. The medical team will carefully review all your test results and medical history to ensure the study is a safe and appropriate option for you.

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.

Are you 18 years old or older?
Do you have bowel cancer that has spread?
Has your cancer not improved with previous standard treatments?
Are you willing to have special tests on your cancer tissue?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive treatment with both temozolomide and pembrolizumab. Temozolomide is usually given as tablets, and pembrolizumab is given through a drip into your vein. You would have regular visits to the hospital for these treatments, and to have various tests, such as blood tests, scans, and physical examinations. These tests help the doctors monitor how you are responding to the treatment and check for any side effects.

Your participation would involve a initial screening period to determine if you are suitable, followed by the treatment phase. After treatment, you would continue to have follow-up appointments to monitor your health and the progress of your cancer. The total length of time you would be involved in the study can vary, depending on how you respond to the treatment and how long the doctors feel it is beneficial for you to continue. The study team will explain the exact schedule in detail.

Potential risks and benefits

Taking part in a clinical trial offers the chance to try new treatments that are not yet widely available, and you would be closely monitored by a specialist medical team. This could potentially lead to an improvement in your condition or slow the progression of your cancer, although there's no guarantee the treatment will work for everyone. However, like all medicines, the study drugs can have side effects, which can range from mild to severe. The medical team will discuss all known and potential risks with you. You are free 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.

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Unverified
Italy

Common questions

What is 'advanced' bowel cancer?

Advanced bowel cancer means the cancer has spread from where it started in the bowel to other parts of the body.

What is immunotherapy?

Immunotherapy is a type of treatment that helps your body's own immune system fight cancer cells more effectively.

What is pembrolizumab (Keytruda)?

Pembrolizumab is a specific immunotherapy drug that is being tested in this study to see if it can help fight bowel cancer.

Can I still get other treatments if I join this study?

Usually, during a study, you will only receive the treatments being tested. Your doctor will discuss this with you. If you withdraw, you can receive standard care.

How long will I be in the study?

The time you spend in the study can vary, depending on your response to treatment and ongoing monitoring. Your study team will give you a detailed timeline.