RecruitingPHASE2INTERVENTIONAL

Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma

This research study is for people in the UK over 18 years old who have anal cancer that has spread to other parts of the body. We are investigating a new treatment approach that combines existing treatments – radiotherapy and specific chemotherapies – with a drug called spartalizumab. Spartalizumab is a type of immunotherapy, which helps your body's immune system fight cancer cells. The main goal is to find out how safe and practical this combined treatment is and if it can help improve outcomes for patients with this type of cancer. This is a Phase 2 study, meaning we are looking closely at how well the treatment works and any side effects it might cause.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Hospitalier Universitaire de Besancon

Enrolment target

Start

09 Jun 2022

Estimated completion

01 Nov 2026

Squamous Cell Anal Carcinoma Metastatic Squamous Cell Carcinoma

What is this study about?

Anal cancer is treated in different ways, and for some people, the cancer can spread to other parts of the body (called metastatic cancer) or come back after initial treatment. When this happens, doctors often use chemotherapy. Recently, a specific chemotherapy combination called mDCF (made up of docetaxel, cisplatin, and 5-fluorouracil) has shown good results in treating advanced anal cancer, and it's now considered a standard treatment for many patients.

Alongside chemotherapy, there's a growing interest in using immunotherapy. Immunotherapy drugs, like spartalizumab, work by helping your own immune system recognise and attack cancer cells. These types of drugs have been helpful in treating other cancers, and researchers believe they could also be effective for anal cancer, especially when combined with chemotherapy. This is because some chemotherapy drugs might actually help immunotherapy work better.

This study aims to combine mDCF chemotherapy, radiotherapy, and spartalizumab. Radiotherapy uses high-energy rays to kill cancer cells. By putting these three treatments together, researchers hope to find a more powerful way to fight metastatic anal cancer. The study will carefully check how patients react to this combination, looking at both its effectiveness and any side effects, to see if it could be a better treatment option in the future.

Key takeaways

This study is for anal cancer that has spread.
It combines radiotherapy, chemotherapy (mDCF), and immunotherapy (spartalizumab).
It aims to find out if this combination is safe and effective.
You must be over 18 and meet specific health requirements.
Your health will be closely monitored throughout the study.

Who may be eligible?

To join this study, you need to be at least 18 years old and have anal cancer that has spread or returned. Your doctor will assess your general health and how well you can carry out daily activities. You'll also need specific scan results (CT, MRI, and PET scans) that show your cancer and were done recently.

There are also some health checks you'll need to pass, like blood tests, to make sure your organs (like your liver and kidneys) and blood cell counts are healthy enough for the treatment. You should also have a life expectancy of at least 12 months. Your doctor will make sure you are suitable for the mDCF chemotherapy combination.

Some conditions would prevent you from joining. For example, if you have certain issues with your immune system, significant heart problems, or if you've had another type of cancer recently (other than some common skin cancers), you might not be able to participate. You must also be able to understand and sign a consent form, showing you agree to take part.

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 or older?
Do you have anal cancer that has spread or come back?
Are you generally well and able to manage daily activities (your doctor will check this)?
Have you had recent scans (CT, MRI, PET) showing your cancer?
Are your blood tests showing healthy organ function (e.g., kidneys, liver)?
Have you discussed joining the study and feel able to give your agreement (consent)?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive a combination of treatments: radiotherapy, the mDCF chemotherapy (which consists of docetaxel, cisplatin, and 5-fluorouracil), and spartalizumab, which is an immunotherapy drug. Before starting, and at regular points throughout the study, you'll have various check-ups. These will include physical examinations, blood tests to monitor your organ function and blood counts, and scans like CT or MRI to see how the cancer is responding. You will also have PET scans.

During your treatment, the study team will closely watch for any side effects and manage them to ensure your comfort and safety. You'll have regular appointments to receive your treatments and to have your health monitored. The exact number of visits and the full duration of your participation will depend on how you respond to the treatment and the study's specific plan, which the study team will explain in detail. You will also have follow-up appointments after your treatment finishes.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new combination treatment that could be more effective against your cancer. However, there are also potential risks involved. Chemotherapy, radiotherapy, and immunotherapy can all cause side effects, which vary from person to person. These could include tiredness, nausea, hair loss, or effects on your immune system. The study team will closely monitor you and manage any side effects. It's important to remember that 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 future medical care.

Locations (5)

Centre Hospitalier Universitaire de Besançon
Verified postcode
Besançon, France· Recruiting
Centre Georges-François Leclerc (CGFL)
Verified postcode
Dijon, France· Recruiting
Hôpital Franco-Britannique
Verified postcode
Levallois-Perret, France· Withdrawn
Centre Léon Bérard
Verified postcode
Lyon, France· Withdrawn
Hôpital Nord Franche Comté
Verified postcode
Montbéliard, France· Recruiting

Common questions

What is 'metastatic' anal cancer?

Metastatic anal cancer means the cancer cells have spread from where they started in the anus to other parts of your body.

What is spartalizumab?

Spartalizumab is a type of immunotherapy. It helps your body's own immune system find and fight cancer cells more effectively.

What is 'Phase 2' in a clinical trial?

Phase 2 means the study is looking carefully at how well the new treatment works and what side effects it might cause, in a small group of people.

Will I get all of these treatments?

Yes, if you join this study, you will receive a combination of radiotherapy, specific chemotherapy drugs (called mDCF), and spartalizumab.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason. It will not affect your future medical care.

How to find out more

Stefano KIM, Pr

stefanokim@gmail.com +33 (0)3 81 47 99 99 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.