Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

CAIRE : COMBINING EPIGENETIC AND IMMUNE THERAPY TO BEAT CANCER

This study, called CAIRE, is exploring a new way to fight advanced cancers by combining two existing medicines: Tazemetostat and Imfinzi. It's a Phase II trial, meaning researchers are looking closely at how effective and safe this new combination might be. They are focusing on adults with advanced pancreatic cancer, certain types of bowel cancer, soft tissue cancers (sarcomas), and other solid tumours that have spread (metastatic) or cannot be removed by surgery. The main goal is to see how many patients experience their cancer shrinking or staying stable after treatment within a specific timeframe, usually 24 weeks or 6 months, depending on the cancer type. This research hopes to find better ways to manage these challenging cancers.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut Bergonie

Enrolment target

173

Start

31 Oct 2024

Adult participants with metastatic or unresectable locally advanced solid tumors.

What is this study about?

This study, named CAIRE, is looking into a new approach to treat certain advanced cancers. It brings together two different types of cancer medicines: Tazemetostat and Imfinzi. Tazemetostat works by affecting how cancer cells grow, while Imfinzi is an immunotherapy that helps your body's own immune system find and fight cancer cells more effectively. Researchers hope that by combining these two medicines, they might be more powerful together than either one alone.

The study is a Phase II trial. This means that previous studies have shown the individual medicines might be safe and could work, and now researchers are carefully studying the combination in a larger group of patients. They want to understand how well the combination shrinks or controls the cancer, and also how safe it is. They are recruiting adults who have cancer that has spread to other parts of the body (metastatic) or is too advanced for surgery (unresectable).

Patients in this study are divided into different groups, called 'cohorts,' based on their specific type of cancer. These include patients with pancreatic cancer, certain bowel cancers, soft tissue sarcomas, and other solid tumours that show particular biological features. For each group, the researchers will be carefully measuring whether the cancer shrinks, stays the same, or grows, usually over a period of 24 weeks or 6 months after starting treatment. This will help them understand if this combined treatment could be a promising new option for these types of advanced cancers.

Key takeaways

This study combines two cancer medicines: Tazemetostat and Imfinzi.
It's for adults with specific advanced or metastatic solid tumours.
The goal is to see if the combination can shrink or control cancer growth.
It's a Phase II trial, focused on safety and effectiveness.
Participants will receive regular medical check-ups and scans.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who have certain types of advanced cancer. This includes people with pancreatic cancer, a specific type of bowel (colorectal) cancer, soft tissue sarcomas, or other solid tumours that have spread throughout the body or can't be removed by surgery.

To join, your cancer must also meet certain criteria. For example, some participants will need to have a positive interferon gamma signature or tertiary lymphoid structures within their tumour, which are specific features that might indicate how well the immune system could respond to treatment.

It's important to discuss your full medical history with the study team, as they will need to check other health conditions and previous treatments to ensure the study medicines are suitable and safe for you.

Quick self-check

Are you 18 years old or older?
Do you have advanced pancreatic cancer, soft tissue sarcoma, a specific type of bowel cancer, or another metastatic solid tumour?
Are you able to attend regular clinic appointments and follow the study schedule?
Are you willing to discuss your full medical history with the study team?

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 receive two medicines: Tazemetostat and Imfinzi. Tazemetostat is likely given as a tablet you take by mouth, while Imfinzi is given as an infusion, meaning it’s delivered directly into your bloodstream through a drip, similar to how other medications are given at the hospital or clinic. The specific schedule for these medicines and how often you'll need to visit the clinic will be explained by the study team.

Throughout the study, you will have regular visits for check-ups. These visits will involve blood tests, physical examinations, and scans (like CT or MRI scans) to monitor your health and see how the treatment is affecting your cancer. These assessments help the doctors understand if the treatment is working and if you are experiencing any side effects.

The total length of time you'll be on the study treatment can vary for each person, depending on how your cancer responds and if you experience any side effects. You will be closely monitored, and the study team will always be available to answer your questions and support you.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and risks. The potential benefit of this study is that the combination of these two medicines might help to shrink or control your cancer more effectively than standard treatments. However, there's no guarantee that the treatment will work for everyone, or that it will work at all. Like all medicines, Tazemetostat and Imfinzi can cause side effects. These can range from mild to more serious, and the study team will discuss all the known and potential side effects with you in detail. Your health will be closely monitored throughout the study to identify and manage any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

—
France

Common questions

What kind of cancers is this study for?

This study is for adults with advanced pancreatic cancer, certain bowel cancers, soft tissue sarcomas, and other solid tumours that are metastatic (have spread) or can't be surgically removed.

What medicines will I receive in the study?

You will receive two medicines: Tazemetostat and Imfinzi. Tazemetostat is typically a tablet, and Imfinzi is given as an infusion (through a drip).

What is a 'Phase II' trial?

Phase II means researchers are closely looking at how effective and safe this new combination of medicines is in a larger group of patients who have specific types of cancer.

How long will I be in the study?

The length of your participation varies. You'll continue treatment as long as it's helping and you're not experiencing significant side effects, with regular monitoring over a period of many months.

What do 'disease control rate' and 'objective response rate' mean?

These are ways doctors measure if the treatment is working. Disease control rate means the cancer has either shrunk, or stayed stable. Objective response rate means the cancer has visibly shrunk.