Efficacy and Safety of L19TNF in Previously Treated Patients with Advanced Stage or Metastatic Soft-tissue Sarcoma
This study is for people with advanced soft tissue sarcoma that has spread or come back after previous treatments. It's investigating a new treatment that combines a drug called onfekafusp alfa (L19TNF) with dacarbazine. The main aims are to find out if this new combination is safe and if it helps to control the cancer. Some patients will receive the new combination, while others will receive dacarbazine alone, to compare their effects. This is a Phase 2 study, meaning it's still in the earlier stages of testing, but it's designed to give a clearer idea of the treatment's potential benefits and side effects.
At a glance
What is this study about?
This research study is looking into a new way to treat a type of cancer called soft tissue sarcoma. This is a cancer that starts in the soft tissues of the body, like muscle, fat, blood vessels, or nerves. This study is specifically for people where the cancer is advanced, meaning it has spread or cannot be removed by surgery, and they have already tried other treatments.
The study is testing a new drug called onfekafusp alfa (which you might see referred to as L19TNF), in combination with a standard chemotherapy drug called dacarbazine. Researchers want to see if adding onfekafusp alfa to dacarbazine is safe and if it can help slow down or stop the growth of the cancer more effectively than dacarbazine alone. This is an important step in finding better treatments for this condition.
This is a 'Phase 2' study, which means it's one of the earlier stages of human testing. It aims to gather more information on how well the new combination works and what side effects it might cause. The results from studies like this help doctors decide if a new treatment should be studied on more people in larger trials.
Key takeaways
- This study tests a new two-drug combination for advanced soft tissue sarcoma.
- It's for people who have already tried other cancer treatments.
- The study aims to check the safety and effectiveness of the new combination.
- You might receive the new combination or a standard drug alone.
- Your health will be closely monitored throughout the study.
Who may be eligible?
To join this study, you would generally need to be between 18 and 80 years old and have soft tissue sarcoma that has been confirmed by a doctor. Your cancer must be advanced or have spread, and you should have already received at least two other types of treatment for it, including one therapy that contained a drug like anthracyclines (unless your doctor advised against it).
It's important that your cancer has shown signs of growing worse after your last treatment. You must also have at least one measurable area of cancer that doctors can track. Certain types of bone sarcomas, Kaposi's sarcoma, and specific stomach cancers (GIST) are not included in this study.
Doctors will also check your overall health, including whether you have certain infections like HIV, Hepatitis B, or Hepatitis C. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test. Your local study team will review all your medical information to see if this study is suitable 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 between 18 and 80 years old?
- Do you have advanced soft tissue sarcoma (not certain other types)?
- Have you already had at least two different treatments for your cancer?
- Has your cancer grown or spread after your last treatment?
- Do you have at least one area of cancer that doctors can measure?
What does participation involve?
If you decide to take part, you'll first go through a 'safety run-in' phase with a small group of patients. This is to test the safety of the new drug combination at a specific dose. You would receive dacarbazine once every three weeks and onfekafusp alfa three times (on Day 1, 3, and 5) every three weeks. If any major problems arise, the doctors might adjust the dose or stop this part of the study.
After this initial safety check, about 86 more patients will be randomly assigned to one of two groups, like flipping a coin. One group will receive the new combination treatment (dacarbazine and onfekafusp alfa) in cycles every three weeks. The other group will receive dacarbazine by itself, also in cycles every three weeks. Throughout the study, your health will be closely monitored, and your cancer's progress will be regularly checked with scans like CTs. You will have regular appointments and tests as part of your treatment and monitoring.
Potential risks and benefits
Locations (23)
- Hopital Jean MinjozVerified postcodeBesançon, France
- Institut BergoniéVerified postcodeBordeaux, France
- Centre Jean PerrinVerified postcodeClermont-Ferrand, France
- Centre Léon BérardVerified postcodeLyon, France
- Institut Paoli-CalmettesVerified postcodeMarseille, France
- Institut régional du Cancer de Montepellier - ICM Val d'AurelleVerified postcodeMontpellier, France
- Institut Claudius RegaudVerified postcodeToulouse, France
- Institut Gustave RoussyVerified postcodeVillejuif, France
- Münster University HospitalVerified postcodeMünster, Germany
- Helios Klinikum Bad SaarowVerified postcodeBad Saarow, Germany
- Helios Klinikum Berlin- BuchVerified postcodeBerlin, Germany
- Klinik rechts der Isar, TU MünchenVerified postcodeMünchen, Germany
Common questions
What is soft tissue sarcoma?
Soft tissue sarcoma is a type of cancer that starts in the body's soft tissues, such as muscles, fat, nerves, and blood vessels.
What is a 'Phase 2' study?
A Phase 2 study is an earlier stage of testing a new treatment in humans. It focuses on how well the treatment works and its side effects in a larger group than Phase 1.
What does 'randomized' mean?
Randomized means that patients are put into different treatment groups by chance, like drawing names from a hat, to make the comparison fair.
Are there other treatment options available?
Yes, your doctor can discuss standard treatment options for soft tissue sarcoma that are available outside of this study.
Will I know which treatment I'm getting?
Yes, this is an 'open label' study, meaning both you and your doctors will know which treatment you are receiving.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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