A study testing zimberelimab, domvanalimab, and sacituzumab govitecan for patients with PD-L1 positive advanced triple-negative breast cancer

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What is this study about?

This study is looking at a specific type of breast cancer called triple-negative breast cancer that has spread to other parts of the body or cannot be removed by surgery. Triple-negative breast cancer is a form of breast cancer where the cancer cells do not have certain proteins on their surface, which makes it different from other types of breast cancer. The study focuses on patients whose cancer tests positive for a marker called PD-L1, which is a protein found on some cancer cells. The treatment being studied involves a combination of three medications given through a vein: zimberelimab (also known by the code name AB122), domvanalimab (also known by the code name AB154), and sacituzumab govitecan (marketed as Trodelvy). These medications work in different ways to help the body fight cancer cells. This combination is being tested as the first treatment for patients who have not yet received any therapy for their advanced disease.

The main goal of this study is to find out how well this three-drug combination works in shrinking or stopping the growth of tumors in patients with this specific type of breast cancer. The study will measure how many patients experience a reduction in the size of their tumors or have their tumors disappear completely. The researchers will also look at how long patients live without their disease getting worse, how long patients survive overall, and how long any positive response to treatment lasts. Additionally, the study will examine the safety of this treatment combination and any side effects that may occur.

Patients in this study will receive the three medications through infusions into a vein at specific time intervals over a treatment period that can last up to twelve months. Throughout the study, patients will have regular check-ups that include imaging scans such as CT scans or MRI scans to see how the tumors are responding to treatment. Blood and stool samples will be collected at various points during the study. Patients will also need to provide a tissue sample from their tumor, either from a previous biopsy or from a new biopsy taken before treatment starts. The study requires that patients have measurable disease that can be tracked using imaging tests, and they must not have received any previous treatment for their advanced cancer, although some prior treatment in earlier stages of the disease is allowed if enough time has passed.

1 Initial assessment and baseline procedures

Before starting treatment, a pregnancy test will be performed if applicable. This test must be completed within 14 days before the first dose of medication.

Blood and stool samples will be collected at designated times throughout the study.

A recent tissue sample from the affected area will need to be provided. If a recent sample is not available, a new biopsy may be required before treatment begins.

Imaging scans such as computerized tomography or magnetic resonance imaging will be performed to document the disease.

2 Treatment phase with study medications

Treatment will consist of a combination of three medications: zimberelimab, domvanalimab, and sacituzumab govitecan.

All three medications will be given through intravenous infusion, which means they will be delivered directly into a vein.

The specific dosage, frequency, and duration of each medication will be determined by the treatment protocol established for the study.

Treatment will continue according to the schedule provided by the medical team overseeing the study.

3 Ongoing monitoring and assessments

Regular blood tests will be performed to monitor blood cell counts, liver function, and kidney function.

Imaging scans will be conducted periodically to assess how the disease is responding to treatment. These assessments will follow RECIST version 1.1 criteria, which are standardized methods for measuring tumor size and response.

Any side effects or changes in health status will be monitored and recorded using the Common Terminology Criteria for Adverse Events version 5.0, a standardized system for describing side effects.

Blood and stool samples will continue to be collected at the designated time points as specified in the study protocol.

4 Treatment continuation or completion

Treatment will continue until the disease progresses, unacceptable side effects occur, or the study protocol determines treatment should stop.

The medical team will regularly evaluate the response to treatment, including whether the disease has decreased in size, remained stable, or progressed.

The duration of response, if the disease responds to treatment, will be measured from the first time a response is documented until the disease progresses or other criteria are met.

5 Post-treatment follow-up period

After completing treatment with the study medications, follow-up will continue to monitor long-term outcomes.

If applicable, contraception must be continued for 6 months after the last dose of study medication.

During this period, egg cell donation, sperm donation, sperm banking, and breastfeeding are not permitted.

The medical team will continue to track survival and any long-term effects of the treatment.

Who Can Join the Study?

You must be 18 years of age or older, of any race or ethnic group, and able to understand and sign a consent form
You must be willing to provide blood and stool samples at specific times during the study
If you are a woman who can become pregnant and are sexually active with a male partner, you must have a negative pregnancy test within 14 days before starting treatment. You must also agree to use highly effective birth control from the time of screening until 6 months after the last dose of study treatment. You must not donate eggs or breastfeed during this time
If you are a male participant who is sexually active with a woman who can become pregnant, you must be surgically sterile or use acceptable birth control from the time of screening until 6 months after the last dose of study treatment. You must not donate or store sperm during this time
You must have an ECOG performance status of 0 to 1, which is a measure of how well you can perform daily activities. A score of 0 means you are fully active, and 1 means you have some restrictions but can still do light work
You must have a life expectancy of at least 12 weeks at the time of screening
You must have triple-negative breast cancer confirmed by tissue examination. This means your cancer has less than 1% expression of estrogen and progesterone receptors and is negative for a protein called HER2
Your cancer must be PD-L1 positive, which means it has a specific protein marker with a score of 10 or higher as measured by a specific test
You must have locally advanced or metastatic disease that cannot be removed by surgery, confirmed by CT scan or MRI. This means the cancer has spread and cannot be cured by surgery alone
You must have measurable disease according to specific criteria. If a tumor is in an area that was previously treated with radiation, it can only be counted if it has clearly grown since the radiation treatment
You must not have received any prior treatment for advanced disease. If you received treatment after diagnosis or before surgery in the past, at least 6 months must have passed between completing that treatment and the cancer coming back
You must have adequate bone marrow, liver, and kidney function. This includes having enough white blood cells, platelets, and hemoglobin in your blood, normal liver enzyme levels, normal bilirubin levels, adequate kidney function, and normal blood clotting times
Any side effects from previous treatments must have resolved to a mild level, except for hair loss or other side effects that your doctor considers safe
You must be willing to provide a tissue sample from where the cancer has spread. If a recent sample is not available, a new biopsy must be taken before starting treatment. If a biopsy cannot be done, your eligibility will be reviewed by the study doctor

Who Cannot Join the Study?

The study document does not list specific reasons why patients cannot participate in this clinical trial
If you are interested in this study, the research team will need to review your complete medical history to determine if you are eligible to participate
General factors that often prevent participation in cancer studies may include having certain other medical conditions, taking specific medications, or having received certain previous treatments, but these specific details are not provided in the available information

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital Universitario Basurto	Bilbao	Spain
Hospital Universitario De Leon	Leon	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Salut Sant Joan De Reus	Reus	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Iwggxopy Crrlne Djiyjsbkugppwdryx	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	31.01.2026

Trial locations

Investigated drugs:

Zimberelimab is a type of immunotherapy medicine that helps your immune system fight cancer cells. It works by blocking a protein that prevents your immune system from attacking the cancer.

Domvanalimab is another immunotherapy medicine that also helps boost your immune system’s ability to recognize and destroy cancer cells. It works in a different way than zimberelimab to help your body fight the disease.

Sacituzumab govitecan is a targeted cancer treatment that combines an antibody with a chemotherapy drug. The antibody part finds cancer cells, and then delivers the chemotherapy directly to those cells to kill them while limiting damage to healthy cells.

Investigated diseases:

Triple negative breast cancer

Triple-Negative Breast Cancer – Triple-negative breast cancer is a type of breast cancer where the cancer cells test negative for three specific receptors: estrogen receptors, progesterone receptors, and HER2 protein. This means the cancer does not respond to hormonal therapy or treatments that target HER2. It tends to grow and spread more quickly than other types of breast cancer. The disease can occur at any age but is more common in younger women and those with certain genetic mutations. When the cancer is advanced, it means it has spread beyond the breast to nearby tissues or to distant parts of the body. The term “locally advanced” refers to cancer that has grown into nearby tissues but has not spread to distant organs, while “metastatic” means it has spread to distant parts of the body.

Trial ID:

2025-521489-80-00

Protocol code:

MEDOPP0653

Trial Phase:

Therapeutic exploratory (Phase II)

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A study testing zimberelimab, domvanalimab, and sacituzumab govitecan for patients with PD-L1 positive advanced triple-negative breast cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?