Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

PICASSO. Prospective randomIzed clinical trial assessing the tolerance and clinical benefit of feCAl tranSplantation in patientS with melanOma treated with CTLA-4 and PD-1 inhibitors

The PICASSO study is a research project for people with advanced melanoma, a type of skin cancer. It's investigating a new treatment named MaaT013, which is a type of 'fecal transplant', meaning it involves carefully prepared gut bacteria. Researchers want to know if MaaT013 is safe to use with existing cancer medications (CTLA-4 and PD-1 inhibitors) and if it can improve how well these treatments work. They will also look at how MaaT013 affects the gut's healthy bacteria and the body's immune response against cancer. This is a Phase II study, meaning it's exploring the treatment's effects in more detail after initial safety checks.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

27 Sep 2024

Melanoma

What is this study about?

The PICASSO study is focusing on advanced melanoma, a serious form of skin cancer. Modern treatments often use special drugs that boost your immune system to fight cancer (like CTLA-4 and PD-1 inhibitors). This study is exploring if adding a new investigational treatment called MaaT013 could make these existing drugs work even better or make them easier to tolerate. MaaT013 is essentially a carefully prepared mix of healthy gut bacteria.

Researchers believe that the types of bacteria living in our gut, known as the gut microbiome, can influence how well our immune system fights cancer and how we respond to cancer treatments. By introducing a healthy mix of bacteria with MaaT013, the study hopes to see if this can shift the balance in a way that helps the body combat melanoma more effectively and possibly reduce side effects from other treatments.

This study is in its 'Phase II'. This means it's still an early stage of testing, looking closely at how safe the treatment is and if there are signs it could be effective. It's not yet about proving it's a standard new treatment, but gathering important information that could lead to larger studies in the future.

Key takeaways

This study is for advanced melanoma patients.
It tests a new treatment called MaaT013, made from gut bacteria.
MaaT013 is given alongside existing immune-boosting cancer drugs.
The study aims to check safety and if MaaT013 improves treatment results.
Participants will receive either MaaT013 or a placebo, chosen randomly.
The study lasts about 27 weeks with longer-term check-ups.

Who may be eligible?

To be considered for the PICASSO study, you generally need to be an adult, at least 18 years old, with advanced melanoma. Doctors will check many other specific health details to see if the study is right for you, ensuring your safety and that the study results are as clear as possible.

For example, they look at your overall health, how your cancer has responded to previous treatments, and any other medical conditions you might have. You'll also need to be receiving specific existing cancer treatments (CTLA-4 and PD-1 inhibitors) at the same time as the study treatment.

The study is open to both men and women. The medical team will review all your health information carefully to decide if participating is suitable and safe 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 18 years old or older?
Do you have advanced melanoma?
Are you currently receiving or about to receive CTLA-4 and PD-1 inhibitor treatments?
Are you comfortable with the possibility of receiving a placebo (dummy treatment) during the study?
Do you have any other significant health conditions that might prevent you from joining a study?

Answer every question to see your result.

What does participation involve?

If you join the PICASSO study, you'll be part of a group comparing MaaT013 to a "placebo" – a dummy treatment that looks just like MaaT013 but contains no active ingredients. You won't know if you're getting MaaT013 or the placebo until after the study is complete, allowing researchers to accurately compare the effects.

You will receive the study treatment (either MaaT013 or placebo) in addition to your standard cancer medications. Throughout the study, which lasts about 27 weeks, you will have regular visits to the clinic. These visits will involve blood tests, physical examinations, and scans to monitor your health, track any side effects, and see how your cancer is responding.

Some participants who initially receive placebo and whose cancer progresses may have the option to receive MaaT013 later. The total duration of active follow-up for safety and treatment response is around 27 weeks, with longer-term follow-up to check overall health and survival at 15, 27, and 51 weeks.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments before they are widely available, and you'll receive very close medical monitoring. While MaaT013 is designed to be safe, like all medicines, it might have side effects, some of which could be serious. The study team will carefully monitor you for any problems. You always have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
France

Common questions

What is MaaT013?

MaaT013 is an investigational treatment made from healthy gut bacteria, similar to a 'fecal transplant'.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but has no active ingredients. It helps researchers compare effects fairly.

How long will the study last?

The main treatment and monitoring period lasts about 27 weeks, with follow-up for up to 51 weeks.

Will I still receive my normal cancer treatment?

Yes, MaaT013 or the placebo will be given in addition to your standard cancer medications (CTLA-4 and PD-1 inhibitors).

What is advanced melanoma?

Advanced melanoma means the skin cancer has spread to other parts of the body.

How to find out more

Official trial record

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