Not recruiting

Study on Nivolumab and Cisplatin for Patients with Metastatic Triple Negative Breast Cancer

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying triple negative breast cancer (TNBC), a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth. The study is investigating the effects of a treatment called nivolumab, which is also known by its code names BMS936558 and ABP 206. Nivolumab is a medication that is given through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. The trial also involves another medication called cisplatin, which is a chemotherapy drug used to treat various types of cancer, including TNBC.

The purpose of this study is to explore how well nivolumab works after different treatments that aim to boost the immune system's response in patients with TNBC that has spread to other parts of the body, known as metastatic disease. Participants in the study will receive nivolumab after undergoing these immune-inducing treatments. The study will monitor how the cancer responds to the treatment and how long patients remain free from cancer progression. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of nivolumab.

Throughout the study, patients will receive regular infusions of nivolumab and will be closely monitored for any changes in their condition. The study will assess various outcomes, including how long patients live without their cancer getting worse and any side effects they may experience. The trial aims to provide valuable information on the effectiveness of nivolumab in treating TNBC and potentially improve treatment strategies for this challenging type of breast cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, eligibility is confirmed based on specific criteria, such as having triple negative breast cancer with metastatic disease, being 18 years or older, and having a maximum of three lines of chemotherapy for metastatic disease.
A metastatic lesion must be accessible for biopsy, and the disease must be measurable or evaluable according to specific guidelines.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current state of the disease. This includes a physical examination and various tests to establish a baseline for future comparisons.
Step 3
Treatment phase
The treatment phase involves receiving medications through intravenous infusion. The medications used are nivolumab and cisplatin, which are administered as solutions for infusion.
The specific dosage, frequency, and duration of administration are determined by the medical team based on individual needs and responses.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment. This includes follow-up visits, imaging tests, and laboratory tests to track the progress of the disease.
The primary goal is to determine the activity of nivolumab after different immune response induction treatments.
Step 5
Evaluation of outcomes
The trial evaluates outcomes such as progression-free survival, which measures the time from the start of treatment to tumor progression or death from any cause.
Secondary outcomes include the response rate, clinical benefit, overall survival, and the percentage of patients experiencing side effects.

Who can join the trial?

8 criteria

Must have triple negative breast cancer (TNBC) that has spread to other parts of the body (metastatic) or cannot be cured with local treatment.
Confirmation that the cancer is ER-negative (less than 10% estrogen receptor) and HER2-negative (HER2 IHC score of 0, 1+, or 2+ without gene amplification).
Must have a metastatic tumor that can be accessed for a biopsy (a small sample of tissue taken for testing).
Must be 18 years old or older.
Can have had up to three different chemotherapy treatments for metastatic cancer, but the cancer must be getting worse.
Must have a WHO performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have cancer that can be measured or evaluated according to RECIST 1.1 criteria, which is a standard way to measure how well a cancer treatment works.
If the cancer returned after initial treatment, the time between the first diagnosis or local recurrence and the first metastasis must be longer than 1 year. This does not apply if the cancer was metastatic from the start or if no chemotherapy was given after surgery.

Who cannot join the trial?

3 criteria

Patients who do not have triple negative breast cancer (TNBC) with metastatic disease cannot participate. Metastatic disease means that the cancer has spread to other parts of the body.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have difficulty giving informed consent or are at higher risk of harm.

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Investigated drugs

Nivolumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, nivolumab is being used to see if it can improve the body's response to cancer in patients with a specific type of breast cancer called triple negative breast cancer, which has spread to other parts of the body.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating triple negative breast cancer (TNBC) with metastatic disease. The main therapeutic use of nivolumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1 on immune cells, which can otherwise prevent the immune system from attacking cancer cells. Nivolumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.

Investigated diseases

Triple Negative Breast Cancer with Metastatic Disease – Triple Negative Breast Cancer (TNBC) is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. This makes it distinct from other breast cancer types, as it does not respond to hormonal therapy or medicines that target HER-2 receptors. TNBC is known for its aggressive nature and rapid growth. When it becomes metastatic, it means the cancer has spread beyond the breast to other parts of the body, such as the bones, liver, or lungs. The progression of metastatic TNBC can vary, but it often involves the cancer cells invading nearby tissues and organs. This spread can lead to a range of symptoms depending on the organs affected.