Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

An open-label, multi-centre, phase I/IIa study evaluating the safety and clinical activity of neoantigen reactive T cells in patients with metastatic or recurrent melanoma

This research study is investigating a new treatment for people with melanoma that has spread or come back. Melanoma is a type of skin cancer. The treatment involves a potential new therapy called ATL001, sometimes given alone and sometimes with another medicine called nivolumab (Opdivo). Researchers want to find out how safe these treatments are by carefully monitoring for any side effects. They will also look at whether the treatment has any effect on the cancer, such as changes in the size of tumours. This is one of the first times this new treatment will be given to people, and it combines two early-stage research steps (Phase I and Phase II) to learn as much as possible.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Achilles Therapeutics UK Limited

Enrolment target

Start

06 May 2024

Metastatic or recurrent melanoma

What is this study about?

This study is looking into a new way to treat melanoma, which is a type of skin cancer that can be very serious, especially if it has spread to other parts of the body or has returned after previous treatment. The main thing researchers want to find out is how safe a new treatment called ATL001 is for people. They will also be checking if it has any positive effects on the cancer itself.

To do this, some patients in the study will receive ATL001 on its own, while others will receive ATL001 along with another established cancer medicine called nivolumab, also known as OPDIVO. The study team will carefully watch participants for any side effects that might happen after receiving the treatments. They will also track changes in the size of the tumours over time to see if the treatment is having an impact.

This study is in its early stages, known as Phase I and Phase II. This means it's one of the first times human patients are receiving this particular treatment. The information gathered will be crucial in understanding if this new therapy could be a promising option for future melanoma treatment. It's a key step in developing new medicines.

Key takeaways

This study is for advanced melanoma that has spread or returned.
It's testing a new treatment called ATL001, sometimes with OPDIVO.
The main focus is on the safety and side effects of the treatment.
Researchers will also track changes in tumour size.
This is an early-stage study (Phase I/IIa) for adults 18 and over.

Who may be eligible?

To join this study, you must be an adult, 18 years old or older. The study is open to both men and women.

It's specifically for people who have melanoma that has either spread to other parts of their body (metastatic) or has come back after they've had treatment before (recurrent). If you have this type of melanoma, you might be able to take part.

As with all clinical trials, there will be other specific health requirements and tests you'd need to pass to make sure the study treatment is suitable and safe for you. Your doctor can discuss these with 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 18 years old or older?
Do you have melanoma?
Has your melanoma spread to other parts of your body or come back?
Are you able to attend clinic visits regularly?

Answer every question to see your result.

What does participation involve?

If you join this study, you would first have some procedures to collect tissue samples. You would also receive medicines designed to prepare your body for the new treatment. Then, you would receive the study treatments, which could be ATL001 by itself or ATL001 combined with nivolumab (OPDIVO), given by infusion. The study team will be closely monitoring you for side effects.

Throughout the study, you would have regular appointments to check your health and assess how the treatment is affecting your cancer. These assessments might include scans to measure tumour size at 6 weeks and 12 weeks, and further follow-up measurements. The exact number of visits and the full duration of your participation would be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer a chance to try a new treatment for your melanoma that isn't available outside of research. However, because this is a new treatment, there could be unknown side effects or it might not work for everyone. The study team will monitor you very closely for any potential risks or side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual 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
Spain

Common questions

What type of cancer is this study for?

This study is for people with advanced melanoma, which is a type of skin cancer that has spread or returned.

What is ATL001?

ATL001 is a new treatment being tested in this study to see if it can help fight melanoma.

Will I get OPDIVO (nivolumab) in this study?

Some participants will receive ATL001 alone, while others will get ATL001 combined with nivolumab (Opdivo).

What does a 'Phase I/IIa' study mean?

It means this is an early study to check the safety of the new treatment and to see if it has any positive effects on the cancer.

What are the main things researchers are looking for?

They are mainly looking to see how safe the treatment is and if it causes any serious side effects, as well as checking for changes in tumour size.