RecruitingPHASE2INTERVENTIONAL

A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma

This research study is looking at a new treatment called tebentafusp for people with clear cell sarcoma that has spread or can't be removed by surgery. The study focuses on patients whose cancer cells have a specific genetic marker, called HLA-A*02:01. Researchers want to find out how effective and safe tebentafusp is for these patients. Patients taking part will receive regular doses of the drug and have scans to check their cancer. Another group of patients who don't have the marker will receive standard treatment chosen by their doctor, also with regular check-ups. The aim is to better understand this new drug and how it compares to existing treatments.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Sarcoma Alliance for Research through Collaboration

Enrolment target

Start

22 Oct 2025

Estimated completion

01 Oct 2030

HLA-A*0201 Positive Cells Present Clear Cell Sarcoma (CCS)

What is this study about?

This clinical trial is a significant step in understanding and potentially treating advanced clear cell sarcoma. Clear cell sarcoma is a rare type of cancer, and this study focuses on patients whose cancer has spread to other parts of the body (metastatic) or cannot be surgically removed (unresectable). The key aspect of this trial is that it's looking at a new drug called tebentafusp, but only for patients whose cancer cells have a particular biological marker on their surface, known as HLA-A*02:01. This marker helps the drug target the cancer more precisely.

This is a 'Phase II' study, which means researchers are trying to find out how well the drug works and how safe it is in a larger group of people, after earlier studies have shown it to be potentially helpful. Patients who join the study will be given tebentafusp weekly, and their progress will be carefully monitored with scans and other tests. The study is 'multi-centre', meaning it's happening in several hospitals, allowing more patients to take part and providing more comprehensive data.

It's important to know that some patients who don't have the HLA-A*02:01 marker, but still have clear cell sarcoma, may also be part of a separate arm of this study. They would receive treatment chosen by their doctors, which is the standard of care, and also have regular check-ups. This helps researchers compare the new drug's effects with existing treatments. Ultimately, the goal is to find better and safer ways to treat clear cell sarcoma.

Key takeaways

This study is testing a new drug for advanced clear cell sarcoma.
It's for patients whose cancer cells have a specific marker called HLA-A*02:01.
The drug, tebentafusp, is given weekly, with regular scans to check progress.
Another group will receive standard doctor's choice treatment for comparison.
Participation involves frequent hospital visits for treatment and monitoring.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you would generally need to be at least 18 years old and have clear cell sarcoma that has been confirmed by a doctor. Your cancer must also have spread or be impossible to remove with surgery. A crucial requirement is that your cancer cells must show a specific marker called HLA-A*02:01.

You would also need to be generally well enough to take part in a study, as assessed by your medical team, and have certain organ functions (like your liver and kidneys) working adequately. Your cancer would need to be measurable on scans, and you should have shown some progression of your disease in the past six months, or be newly diagnosed with widespread disease.

However, you wouldn't be able to join if you've had a severe allergic reaction to similar drugs in the past, or if you have significant heart problems. This study is for all genders.

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 at least 18 years old?
Do you have clear cell sarcoma that has spread or cannot be removed by surgery?
Has your doctor confirmed your cancer cells have the HLA-A*02:01 marker?
Are you generally well enough to participate in a study, and does your heart and other organs function adequately?
Have you had recent progression of your cancer, or are you newly diagnosed with widespread disease?
Do you have any serious heart conditions or a history of severe allergic reactions to similar drugs?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first undergo some screening tests to ensure you meet all the requirements. This includes a special test to check for the HLA-A*02:01 marker in your cancer cells, as well as blood tests and scans.

If eligible for the tebentafusp treatment, you would receive the drug weekly. You would have scans (like CT or MRI) at the beginning of the study, then every 6 weeks for nearly a year, and then every 9 weeks after that. These scans help doctors see how the treatment is affecting your cancer. You would continue treatment until your cancer starts to grow again, or if you experience side effects that are too difficult to manage.

Some patients will also be asked to provide small tissue samples (biopsies) from their tumour at the beginning and around week 6 of treatment, if it's safe to do so. Regular blood samples will also be collected throughout the study for further research. If you are in the group receiving treatment chosen by your doctor, you would also have regular scans and check-ups on a similar schedule.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments before they are widely available, which could potentially help control your clear cell sarcoma. However, there's no guarantee that the new drug will work for everyone, and it might not be more effective than standard treatments. Like all medicines, tebentafusp can cause side effects, which could range from mild to severe. Your doctors and nurses will monitor you very closely for any side effects and will discuss these with you in detail before you decide to join. It's important to remember that you can choose to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (3)

University of Southern California - Norris Cancer Center
Verified postcode
Los Angeles, United States· Recruiting
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
Royal Marsden
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is clear cell sarcoma?

Clear cell sarcoma is a very rare type of cancer that usually affects soft tissues, often near tendons or joints, especially in the arms and legs.

What does HLA-A*02:01 positive mean?

This refers to a specific protein marker found on the surface of some cells, including certain cancer cells. For this study, the new drug is designed to target cancer cells that have this particular marker.

What is a 'Phase II' study?

A Phase II study means the drug has already shown some promise in earlier tests. Now, researchers want to see how well it works and how safe it is in a larger group of patients.

Will I definitely get the new drug?

If you have the HLA-A*02:01 marker and meet all other study requirements, you will receive the new drug. If you don't have the marker, you might be offered to take part in a different part of the study receiving standard treatment.

How long would I be in the study?

You would continue treatment until your cancer starts to grow again or if the side effects become too difficult. Scans are planned regularly for at least 48 weeks and then every 9 weeks thereafter.

How to find out more

SARC Office

sarc045@sarctrials.org (734) 930-7600 Official trial record

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