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

ABIMMUNE: A Phase I/II study evaluating the safety and clinical activity of anti-PDL1 (Durvalumab [MEDI4736]) + Anti CTLA-4 (Tremelimumab) antibodies administrated in combination with stereotactic body radiotherapy (SBRT) in patients with metastatic squamous cell carcinoma of head and neck, lung, oesophageus, cervix, vagina, vulva or anus.

This research study, called ABIMMUNE, is investigating a new way to treat certain cancers that have spread to other parts of the body. These cancers include those in the head, neck, lung, food pipe (oesophagus), cervix, vagina, vulva, or anus. Doctors are combining two new cancer drugs, Durvalumab (Imfinzi) and Tremelimumab (Imjudo), with a highly focused type of radiation treatment called SBRT. In the first part of the study (Phase 1), the main goal is to check the safety of this combined treatment and find the right dose. In the second part (Phase 2), we want to see how well the treatment works to shrink tumours that are outside the area treated by radiation. Patients will have scans to help us understand the effects of the treatment. This study aims to find better ways to fight these cancers.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Institut Gustave Roussy

Enrolment target

Start

09 Jul 2024

Metastatic squamous cell carcinoma of head and neck lung esophagus cervix vagina vulva or anus to be treated with SBRT

What is this study about?

This study is looking into a new way to treat certain types of advanced squamous cell carcinoma. This is a type of cancer that can develop in different parts of the body, such as the head and neck, lungs, food pipe (oesophagus), and female genital areas like the cervix, vagina, or vulva, as well as the anus. When cancer has spread to other parts of the body, it's called metastatic cancer.

Doctors are combining two special cancer drugs called Durvalumab (known as Imfinzi) and Tremelimumab (known as Imjudo) with a focused radiation therapy called SBRT (Stereotactic Body Radiotherapy). SBRT is a high-dose radiation treatment that targets tumours very precisely. Both Imfinzi and Imjudo are types of immunotherapy. Immunotherapy is a treatment that helps your body's own immune system fight cancer cells.

The main reasons for doing this study are to first make sure this combination is safe and to find the best doses of the drugs when given with SBRT. After that, the study will check to see how well this combined treatment works to shrink tumours. Researchers will use body scans to see how the cancer responds to the treatment, especially in areas not directly treated with radiation. The hope is that this new combination could offer a more effective way to treat these specific cancers.

Key takeaways

This study combines two new immunotherapy drugs with a targeted radiation therapy (SBRT).
It's for specific types of cancer that have spread (metastatic squamous cell carcinoma).
The study aims to check safety and see if the treatment shrinks tumours.
Participation involves regular treatments, blood tests, and CT scans.
You'll be monitored closely for side effects and how your cancer responds.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, people must be at least 18 years old. Both men and women can take part. The study is specifically for patients who have certain types of cancer that have spread to other parts of their body.

These cancers include squamous cell carcinoma of the head and neck, lung, oesophagus (food pipe), cervix, vagina, vulva, or anus. You would need to be suitable to receive a particular type of radiation treatment called SBRT (Stereotactic Body Radiotherapy).

There will be other health checks and requirements to make sure the treatment is safe for you, and a medical team will discuss all of these details with you. Generally, patients need to be well enough to receive combination cancer treatments.

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 metastatic squamous cell carcinoma of the head and neck, lung, oesophagus, cervix, vagina, vulva, or anus?
Are you able to receive SBRT (a specific type of radiation therapy)?
Are you otherwise well enough to receive combination cancer treatments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive a combination of radiation therapy (SBRT) and two drugs given by infusion into your vein (Imfinzi and Imjudo). You will have regular appointments and tests, including blood tests and CT scans, to see how you are responding to the treatment and to check for any side effects. These scans will help doctors measure the size of your tumours.

In the first part of the study, the focus is on finding the safest dose of the drugs, so you might have more frequent checks. Later, the focus will be on how well the treatment is working. You will continue to be monitored for some time after your treatment finishes to see how you are doing in the longer term. Your medical team will explain the full schedule of visits, treatments, and follow-up scans or appointments, including the total length of your participation, before you make any decisions.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to new treatments that are not yet widely available and could potentially help shrink your cancer. However, like all medical treatments, there are potential risks and side effects from the drugs and radiation, which the study team will monitor closely. These could include common side effects from immunotherapy or radiation, and some could be serious. You will be fully informed about all known and potential risks before you decide to join. It is very important to remember that participating in a study is completely voluntary, and you have the right to withdraw 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
France

Common questions

What is squamous cell carcinoma?

It's a type of cancer that starts in the flat, thin cells lining parts of the body, like the surface of the skin or inside certain organs.

What does 'metastatic' mean?

It means the cancer has spread from where it first started to other parts of the body.

What is SBRT?

SBRT stands for Stereotactic Body Radiotherapy. It's a special type of radiation treatment that delivers very precise, high doses of radiation to a tumour while trying to spare healthy tissues.

What are Imfinzi and Imjudo?

These are cancer drugs called immunotherapies. They work by helping your body's own immune system find and fight cancer cells more effectively.

Will this treatment cure my cancer?

This study is testing a new treatment combination, and while we hope it helps, there's no guarantee of a cure. The aim is to find out if it's safe and effective in shrinking tumours.