Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

SOLTI-1904: EfficACy of tislelizumab and spartalizumab acROss multiPle cancer-types in patients with PD1-high mRNA expressing tumOrs defined by a singLe and pre-specIfied cutoff (ACROPOLI trial)

The ACROPOLI study is a Phase II clinical trial looking into new ways to treat advanced cancer that has spread to other parts of the body. Doctors are investigating treatments called Tevimbra and PDR001. These treatments are designed to work by targeting specific changes within cancer cells that have high levels of something called 'PD1-high mRNA'. The main aim of the study is to see how much the tumours shrink (called the 'Overall Response Rate') in patients receiving these treatments. Researchers also want to understand other aspects, such as how long people live without their cancer getting worse, how long the treatment benefits last, and how the medicine affects their overall health and quality of life. This study is for adults over 18.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Solti Group

Enrolment target

184

Start

11 Oct 2024

Metastatic disease

What is this study about?

This study, called ACROPOLI, is a clinical trial exploring new treatments for advanced cancers that have spread to other parts of the body. Such cancers are known as 'metastatic disease'. The doctors are testing two medicines, Tevimbra and PDR001, to see how effective they are. These medicines are a type of treatment that works with your body's immune system to fight cancer.

Researchers are particularly interested in patients whose tumours have a specific genetic feature called 'PD1-high mRNA'. This feature might make certain cancers respond better to these types of treatments. The main purpose of the study is to measure how much the tumours shrink or disappear in patients taking part. This is a common way to judge if a cancer treatment is working.

Besides tumour shrinkage, the study will also look at how long patients stay well (meaning their cancer doesn't get worse), how long the treatment's benefits last, and how long patients live overall. Comparing these new treatments to current options helps doctors understand if they could offer a better way to manage advanced cancer in the future.

Key takeaways

This study explores new treatments for advanced, spreading cancers.
It targets cancers with a specific genetic feature (PD1-high mRNA).
The main goal is to see how much tumours shrink.
Researchers also track survival and how long benefits last.
It's a Phase II trial, focusing on treatment effectiveness and safety.
Open to adults aged 18 and over.

Who may be eligible?

This study is open to adults who are at least 18 years old. Both men and women are welcome to take part.

You might be considered for this study if you have metastatic disease, which means your cancer has spread from where it started to other parts of your body.

However, there are other important health details that the medical team will need to check to make sure the study is right and safe for you. This will involve reviewing your specific type of cancer and your overall health.

Quick self-check

Are you 18 years old or older?
Has your cancer spread to other parts of your body (metastatic disease)?
Are you able to attend regular hospital visits and appointments?
Are you willing for doctors to check for the 'PD1-high mRNA' marker in your cancer cells?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will receive either Tevimbra or PDR001 as an infusion, likely in a hospital or clinic setting. You would have regular visits with the study doctors and nurses who will monitor your progress and health. These visits will involve physical examinations, blood tests, and scans (like CT scans or MRI scans) to see how your cancer is responding to the treatment and to check for any side effects. The exact schedule of visits and treatments will be explained to you in detail by the study team. You'll be closely monitored throughout the study, and your health will be tracked over a period of time to understand the full effects of the treatment. The total duration of your participation would depend on your response to the treatment and the study's design.

Potential risks and benefits

Taking part in a clinical trial might offer you access to new treatments that aren't yet widely available, which could potentially help your condition. However, new treatments can also have side effects, some of which might be serious or unexpected. The study team will explain all known risks and potential benefits before you decide to join. Your safety and well-being will always be a priority, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Spain

Common questions

What does 'metastatic disease' mean?

It means your cancer has spread from its original site to other parts of your body.

What kinds of cancers is this study looking at?

This study looks at various types of advanced cancer that have spread, specifically focusing on those with a genetic marker called 'PD1-high mRNA'.

What are Tevimbra and PDR001?

These are the names of the new medicines being tested in the study. They are types of immunotherapy, designed to help your body's immune system fight cancer.

What is a 'Phase II' study?

A Phase II study usually focuses on whether a new treatment works and to gather more information on its safety and side effects, after an initial Phase I study.

Will I know if I'm getting Tevimbra or PDR001?

The study team will explain exactly which treatment you'll receive as part of the study design.