Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

SPARTANA : Spartalizumab, mDCF (docetaxel, cisplatin and 5-fluorouracil) and radiotherapy in patients with metastatic squamous cell anal carcinoma. A Phase IIA study

This study, called SPARTANA, is looking for better ways to treat a specific type of anal cancer that has spread to other parts of the body (metastatic squamous cell anal carcinoma). It's a Phase II study, meaning researchers are carefully exploring new treatments. The study combines standard chemotherapy drugs (docetaxel, cisplatin, and fluorouracil) and radiotherapy with a new investigational drug called spartalizumab (PDR001). The main goal is to see how many patients are still alive and whose cancer hasn't grown worse after one year. This helps doctors learn if this new combination could be a more effective treatment option for patients with this type of cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Regional Universitaire

Enrolment target

Start

22 Aug 2024

metastatic squamous cell anal carcinoma

What is this study about?

This research study, called SPARTANA, is looking into new ways to treat a specific kind of cancer called squamous cell anal carcinoma, especially when it has spread to other parts of the body. When cancer spreads, it's called metastatic. The aim is to find treatments that work better and help people live longer without their cancer getting worse.

In this study, doctors are combining treatments that are already used for cancer with a new investigational drug. The standard treatments include chemotherapy drugs like docetaxel, cisplatin, and fluorouracil, along with radiotherapy, which uses X-rays to kill cancer cells. The new drug, spartalizumab (also known as PDR001), is a type of immunotherapy.

The main question the study wants to answer is whether adding this new drug to the existing treatments can increase the number of patients whose cancer doesn't get worse for at least one year. Knowing this helps doctors understand if this combination could be a good new option for people facing this challenging cancer.

Key takeaways

This study evaluates new treatment for anal cancer that has spread.
It combines standard treatments with an investigational drug (spartalizumab).
The main goal is to see if patients live longer without their cancer growing.
You would receive regular care and close monitoring.
Participation involves known risks and potential benefits.

Who may be eligible?

To join this study, you would need to meet certain conditions. These conditions are in place to make sure that the study is safe for you and that the results are clear and accurate. You must be at least 18 years old.

Both men and women can take part in this study. The doctors and nurses running the study will review your medical history and perform some checks to make sure you fit all the requirements. This might include understanding your general health and how well your body systems are working.

It's important to have an open conversation with your doctor or the study team about all aspects of your health to see if this study is suitable for you. They will explain everything in detail.

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?
Have you been diagnosed with metastatic squamous cell anal carcinoma?
Are you able to travel to study visits?
Are you willing to follow a specific treatment and monitoring schedule?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive a combination of treatments. This includes specific chemotherapy drugs (docetaxel, cisplatin, and fluorouracil), radiotherapy, and the investigational drug spartalizumab (PDR001). The exact schedule for these treatments, including how often you receive them and for how long, will be carefully planned by the study team.

You would have regular visits to the hospital or clinic. During these visits, doctors and nurses will monitor your health closely, check how you're responding to the treatment, and look for any side effects. This will involve physical examinations, blood tests, and scans (like CT scans) to see if the cancer is growing or shrinking. These assessments will help the researchers understand how well the treatment is working.

After your main treatment period, there will be a follow-up period where you'll continue to have check-ups. The main goal for this study is to see how your health is after one year, specifically if the cancer has not grown worse. The total duration of your participation, including follow-up, will be explained by the study team.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new and potentially effective treatment combination that might not be available otherwise. However, there are also potential risks involved. The treatments used, including chemotherapy, radiotherapy, and the investigational drug, can have side effects that range from mild discomfort to more serious reactions. The study team will explain all known side effects and monitor you closely. 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
France

Common questions

What is squamous cell anal carcinoma?

It's a type of cancer that starts in the cells lining the anus. 'Metastatic' means it has spread to other parts of the body.

What does a 'Phase II' study mean?

It means this study is carefully exploring if a new treatment combination is effective and safe once it has already shown some promise in earlier testing.

What is an investigational drug?

It's a medication that is still being tested and is not yet approved for general use. In this study, it's called spartalizumab (PDR001).

What do 'PFS rate' and 'RECIST criteria' mean?

PFS (Progression Free Survival) rate means how many people are alive without their cancer getting worse. RECIST criteria are standard rules doctors use to measure if cancer has shrunk, stayed the same, or grown.

Will I have to pay to be in the study?

No, you should not have to pay for the experimental treatments or study-related care if you participate in a clinical trial.