Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A PHASE II TRIAL EVALUATING THE SAFETY AND EFFICACY OF THE COMBINATION OF ZIMBERELIMAB, DOMVANALIMAB, AND SACITUZUMAB GOVITECAN AS FIRST-LINE THERAPY FOR PD-L1 POSITIVE ADVANCED TRIPLE-NEGATIVE BREAST CANCER (The ADJUNCT Study)

This research, called 'The ADJUNCT Study', is looking at new treatments for a type of breast cancer called advanced triple-negative breast cancer, specifically when it has a marker called PD-L1. Doctors are testing a combination of three drugs: Zimberelimab, Domvanalimab, and Sacituzumab Govitecan (also known as Trodelvy). This Phase II study will examine how safe these drugs are together and how well they work to shrink tumours. The main goal is to see if a good number of patients see their tumours shrink or disappear. It's an important step in finding better ways to treat this challenging cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Medica Scientia Innovation Research S.L.

Enrolment target

Start

09 Dec 2025

PD-L1 POSITIVE ADVANCED TRIPLE-NEGATIVE BREAST CANCER

What is this study about?

This study is a Phase II clinical trial investigating a new approach to treating advanced triple-negative breast cancer. 'Advanced' means the cancer has spread from where it started, and 'triple-negative' describes a specific type of breast cancer that doesn't have certain hormone receptors or too much of a protein called HER2. This makes it harder to treat with some common therapies.

Researchers are focusing on patients whose cancer also has a marker called PD-L1. They are testing a combination of three different drugs: Zimberelimab, Domvanalimab, and Sacituzumab Govitecan (you might know Sacituzumab Govitecan by its brand name, Trodelvy). These drugs work in different ways to fight cancer, with some helping the body's immune system recognise and attack cancer cells, and others directly targeting cancer cells.

The main aim is to find out if this combination of drugs is safe enough to use and how effective it is in shrinking tumours or making them disappear. This study is crucial because it could lead to new and better treatment options for people with this particular type of breast cancer.

Key takeaways

This study is for advanced triple-negative breast cancer with a PD-L1 marker.
It tests a combination of three new drugs (Zimberelimab, Domvanalimab, Trodelvy).
The main goal is to check safety and how well the drugs shrink tumours.
It's a Phase II trial, meaning it's focused on understanding effectiveness and side effects.
Could help find new treatment options for this specific breast cancer type.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. Both men and women can take part. You must have advanced triple-negative breast cancer that has spread.

Also, a specific test on your cancer cells must show that you have the 'PD-L1 positive' marker. This is important because the drugs being tested are designed to work against cancer with this particular feature.

Quick self-check

Are you 18 years old or older?
Do you have advanced triple-negative breast cancer?
Has your cancer spread?
Has your cancer been tested and found to be 'PD-L1 positive'?

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

What does participation involve?

The detailed involvement in this study would be explained by the study team, but generally, participants would receive the study drugs as infusions (into a vein). You would have regular visits to the clinic for these treatments and to monitor your health. These visits would include physical exams, blood tests, and scans (like CT scans) to see how your body is responding to the treatment and whether your cancer is shrinking. You would continue treatment and follow-up for a period, which could last several months or longer, depending on how you are responding to the medication and what the study doctors advise. The total duration of participation varies for each person.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to new treatments before they are widely available, and close medical monitoring. However, there are also potential risks, including side effects from the study drugs, which can vary from mild to severe, and the treatment might not work for everyone. You will be fully informed of all known side effects before you decide to join. It's important to remember that you have the right 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 'triple-negative breast cancer' mean?

It means the cancer cells don't have certain hormone receptors or a protein called HER2, making it a specific type of breast cancer.

What is PD-L1 positive?

PD-L1 is a marker that can be found on some cancer cells. If your cancer is 'PD-L1 positive,' it means the drugs in this study might be able to target it.

What are Zimberelimab, Domvanalimab, and Trodelvy?

These are the names of the three drugs being tested together in this study. They are designed to fight cancer in different ways.

What is a 'Phase II' study?

A Phase II study is a stage of clinical research that looks at whether a new treatment is safe and effective in a larger group of people than a Phase I study.

Will I definitely get these drugs if I join?

Yes, in a Phase II trial, all participants typically receive the study treatment being tested, though specifics will always be explained by the research team.