AuthorisedTherapeutic exploratory (Phase II)Interventional

A phase 2, Multicenter Study of TILs Treatment in Germ Cell tumors: the ARES Study

This study, called ARES, is investigating a new way to treat specific germ cell tumours that haven't got better with current chemotherapy treatments. It's a 'Phase 2' study, which means it builds on earlier research to see how effective and safe the new approach is in a larger group of people. The treatment involves using special immune cells, called Tumour Infiltrating Lymphocytes (TILs), taken from the patient's own tumour, grown in a lab, and then given back to them. This is combined with other medicines called Aldesleukin, Fludarabine, and Cyclophosphamide. The main goal is to see if this treatment can shrink tumours or stop them from growing, and how well patients respond overall. Researchers will also be monitoring for any side effects.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Enrolment target

Start

04 Nov 2025

Germ Cell Tumors refractory to salvage chemotherapy

What is this study about?

This study, known as the ARES study, is focused on finding new ways to treat germ cell tumours. These are cancers that usually start in the reproductive organs, but can sometimes appear in other parts of the body. The study is specifically for patients whose germ cell tumours have not responded well to the usual chemotherapy treatments they’ve already received.

The treatment being tested is a type of immunotherapy. This means it works by helping your body's own immune system fight the cancer. It involves taking immune cells, called Tumour Infiltrating Lymphocytes (TILs), directly from a sample of your tumour. These TILs are special because they have already found their way into the tumour and are trying to fight it. In the lab, these TILs are greatly increased in number and made stronger to be more effective. Afterwards, they are given back to you through an infusion.

Alongside these special TIL cells, you will also receive some other medicines: Aldesleukin, Fludarabine, and Cyclophosphamide. These medicines help to prepare your body for the TILs and boost their cancer-fighting power. The main aim of the study is to see how many people respond positively to this treatment, meaning their tumours shrink, stop growing, or specific cancer markers in their blood decrease. Researchers will also be carefully checking for any side effects.

Key takeaways

New immunotherapy treatment for specific advanced germ cell tumours.
For patients whose tumours haven't responded to standard chemotherapy.
Uses patient's own immune cells (TILs) to fight cancer.
Involves TILs combined with other supportive medications.
Aims to shrink tumours, stop growth, and improve cancer markers.
Close monitoring for safety and how well the treatment works.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or over. This study is open to both men and women. The key requirement is that you have been diagnosed with a germ cell tumour that has unfortunately not responded to standard chemotherapy treatments.

Basically, if your current treatments for a germ cell tumour haven't been successful, and you meet the general age and health requirements, you might be able to take part. The research team will do a thorough check to make sure the study is a good fit for you and that taking part would be safe.

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 a germ cell tumour?
Has your germ cell tumour not improved with previous chemotherapy treatments?
Are you generally healthy enough to take part in a clinical study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will undergo a series of assessments, including regular checks of your tumour size and levels of cancer markers in your blood. You will receive the special TIL cells through an infusion, along with the other medicines (Aldesleukin, Fludarabine, and Cyclophosphamide) as prescribed by the study doctors. The study will involve a number of visits to the clinic for treatments, tests, and to monitor your health and any side effects. These could include blood tests, imaging scans (like CT or MRI scans), and physical examinations. The exact schedule of these visits and treatments will be explained in detail by the study team. You will be closely monitored for your safety and how you are responding to the treatment throughout the study period. The duration of your active participation will depend on how you respond to the treatment, but ongoing follow-up will be necessary.

Potential risks and benefits

Taking part in a clinical trial like this offers potential benefits, such as access to a new treatment that isn't yet widely available, and helping to advance medical knowledge. However, there are also potential risks, including side effects from the new treatments, which can vary in severity. The research team will carefully explain all known and potential risks before you decide to participate. You have the right 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.

—
Unverified
Spain

Common questions

What are germ cell tumours?

Germ cell tumours are a type of cancer that usually starts in cells that are meant to develop into sperm or eggs, but can sometimes appear elsewhere in the body.

What does 'refractory to salvage chemotherapy' mean?

It means the cancer has not responded to previous chemotherapy treatments, even those given after the first attempt to cure or control the cancer was unsuccessful.

What are TILs?

TILs are special immune cells, called Tumour Infiltrating Lymphocytes, taken from your own tumour. They are grown in a lab to become stronger and then given back to you to fight your cancer.

What is a Phase 2 study?

A Phase 2 study is a stage of research where doctors test a new treatment on a larger group of patients to see if it works and to further check its safety.

Will I get 'Aldesleukin, Fludarabine, and Cyclophosphamide' as well?

Yes, these are other medicines that are given along with the TIL cells to help them work better and prepare your body for the treatment.