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Study on ADP-A2M4CD8 and Nivolumab for Patients with Recurrent Ovarian Cancer

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What is this study about?

This clinical trial is focused on studying a treatment for recurrent ovarian cancer, which is a type of cancer that comes back after initial treatment. The study is investigating the effects of a new treatment called ADP-A2M4CD8, which involves using the patient’s own immune cells, known as T cells, that have been genetically modified to target cancer cells. These T cells are designed to recognize and attack cancer cells that express a specific protein called MAGE-A4. The trial will also explore the combination of this treatment with another medication called nivolumab, which is known to help the immune system fight cancer.

The purpose of the study is to evaluate how well these treatments work in patients with recurrent ovarian cancer. Participants in the study will receive either the ADP-A2M4CD8 treatment alone or in combination with nivolumab. The treatments are given through an infusion, which means they are delivered directly into the bloodstream. The study will monitor the participants over a period to see how their cancer responds to the treatment and to check for any side effects.

This trial is open-label, meaning both the researchers and participants know which treatment is being administered. The study aims to provide valuable information on the effectiveness and safety of using genetically modified T cells, both alone and with nivolumab, in treating recurrent ovarian cancer. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the treatment’s impact on their cancer.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes a review of medical history and a series of tests to ensure the patient meets the criteria for participation.

Eligibility criteria include a confirmed diagnosis of recurrent ovarian cancer, specific genetic markers, and a satisfactory health status.

2 leukapheresis

Leukapheresis is a procedure to collect white blood cells, which are used to create the personalized treatment. This involves drawing blood, separating the white blood cells, and returning the remaining blood components to the body.

This step is crucial for preparing the genetically modified T-cells that will be used in the treatment.

3 treatment preparation

The collected white blood cells are modified in a laboratory to target cancer cells. This process involves engineering the cells to express specific receptors that recognize and attack the cancer.

This preparation phase may take several weeks.

4 lymphodepletion

Before receiving the modified T-cells, a short course of chemotherapy is administered to reduce the number of existing immune cells. This is known as lymphodepletion and helps the new cells to function more effectively.

The specific chemotherapy regimen and duration will be explained by the healthcare team.

5 t-cell infusion

The modified T-cells are infused into the bloodstream through an intravenous line. This is the main treatment phase where the cells begin to target and attack the cancer.

The infusion is monitored closely by medical staff to manage any immediate reactions.

6 nivolumab administration

In addition to the T-cell infusion, nivolumab, a medication that helps the immune system fight cancer, is administered. This is given as an intravenous infusion.

The dosage and frequency of nivolumab will be determined by the healthcare team, typically continuing for several months.

7 follow-up and monitoring

Regular follow-up appointments are scheduled to monitor the response to treatment and manage any side effects. This includes physical exams, imaging tests, and blood tests.

The healthcare team will assess the effectiveness of the treatment and make any necessary adjustments.

8 long-term follow-up

After the main treatment phase, long-term follow-up is conducted to evaluate the ongoing effects of the treatment and ensure the patient’s well-being.

This phase may continue for several years, with periodic assessments as needed.

Who Can Join the Study?

  • The patient must voluntarily agree to participate by signing a written consent form.
  • The patient must have a heart function test result called left ventricular ejection fraction (LVEF) of at least 50% or the lowest normal value set by the hospital.
  • The patient must be able to undergo a procedure called leukapheresis, which involves collecting blood cells, and have suitable veins for this procedure.
  • If the patient can have children, they must have a negative pregnancy test and agree to use a reliable form of birth control during the study and for a certain period after treatment ends. They must also agree not to donate or store eggs during this time.
  • The patient must agree to follow all study procedures and assessments as required by the study guidelines.
  • The patient must be between 18 and 75 years old at the time of signing the initial consent form.
  • The patient must have a confirmed diagnosis of a specific type of recurrent ovarian cancer, which includes certain types of cancer in the ovaries, peritoneum, or fallopian tubes.
  • The patient must have a measurable disease according to specific criteria before a treatment step called lymphodepletion, but not necessarily before the leukapheresis procedure.
  • The patient must have received certain previous treatments for their cancer, including:
    • At least 3 cycles of a specific type of chemotherapy for the initial treatment.
    • Up to 4 previous treatment regimens, which may include experimental treatments.
    • If only one line of platinum-based therapy was received, the cancer must have progressed between 93 and 183 days after completing this therapy.
    • If two or more lines of platinum-based therapy were received, the cancer must have progressed during or within 183 days after the last therapy.
    • If the patient has a known BRCA mutation, they must have received a specific type of drug called a PARP inhibitor.
    • The patient must have received a drug called bevacizumab.
  • The patient must test positive for specific genetic markers called HLA-A*02 alleles, as determined by a designated laboratory.
  • The patient’s tumor must show a certain level of a protein called MAGE-A4, confirmed by a laboratory test.
  • The patient must have a performance status of 0 or 1 on a scale used to assess how the disease affects daily living abilities, known as the Eastern Cooperative Oncology Group (ECOG) performance status.

Who Cannot Join the Study?

  • Patients who do not have recurrent ovarian cancer that is positive for MAGE-A4. MAGE-A4 is a specific protein found in some cancer cells.
  • Patients who are not HLA-A2 positive. HLA-A2 is a type of protein on the surface of cells that helps the immune system recognize which cells belong in the body and which do not.
  • Patients who are not female, as the study is only for female subjects.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population that the study does not include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Lyon Sud Pierre Benite France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
27.09.2023
Spain Spain
Not recruiting
27.09.2023

Trial locations

Investigated drugs:

ADP-A2M4CD8 is a type of therapy that uses genetically modified T-cells. These T-cells are taken from the patient’s own body and are changed in a lab to help them better recognize and attack cancer cells. In this trial, the therapy is being tested to see how well it works on its own in treating recurrent ovarian cancer.

Nivolumab is a medication that helps the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells. In this trial, nivolumab is being used in combination with ADP-A2M4CD8 to see if the two treatments together are more effective in treating recurrent ovarian cancer.

Investigated diseases:

Recurrent Ovarian Cancer – This is a type of cancer that returns after initial treatment and remission. It originates in the ovaries, which are part of the female reproductive system. The recurrence can happen months or years after the first occurrence. It often involves the same type of cancer cells as the original tumor. The disease may spread to other parts of the body, such as the abdomen or pelvis. Symptoms can include abdominal pain, bloating, and changes in bowel habits.

Trial ID:
2024-512138-13-00
Protocol code:
ADP-0055-003
NCT ID:
NCT05601752
Trial Phase:
Therapeutic exploratory (Phase II)

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