Recruiting

Study on the Effectiveness of Volrustomig in Women with High-Risk Locally Advanced Cervical Cancer After Chemoradiation Therapy

Fast replyRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying the effects of a new treatment called volrustomig in women with locally advanced cervical cancer. Cervical cancer is a type of cancer that occurs in the cells of the cervix, which is the lower part of the uterus that connects to the vagina. The study aims to determine if volrustomig is safe and effective for patients who have not shown disease progression after receiving a combination of chemotherapy and radiation therapy, known as chemoradiation.

Volrustomig, also known by its code name MEDI5752, is a type of medication called a monoclonal antibody. It is designed to target specific proteins in the body that may help the immune system fight cancer cells. In this study, volrustomig will be compared to a placebo to see if it can improve outcomes for patients. The study will also involve other medications such as Mycofit and Remsima, which are used in different contexts within the trial. Mycofit contains the active substance mycophenolate mofetil, and Remsima contains infliximab.

Participants in the trial will receive either volrustomig or a placebo through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the participants over time to assess the progression of the cancer and overall survival rates. The goal is to see if volrustomig can help delay the progression of the disease and improve the quality of life for those affected by locally advanced cervical cancer. The trial is expected to continue until 2029, with recruitment starting in 2024.

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 study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, weight, and medical history related to cervical cancer.
A tumor sample is required to assess PD-L1 expression, which is a protein that may affect how the body responds to cancer treatment.
Step 2
Randomization
Participants are randomly assigned to receive either the study medication volrustomig or a placebo. This process ensures that the study results are unbiased.
Step 3
Treatment phase
The treatment involves receiving volrustomig or a placebo through an intravenous infusion. The frequency and duration of these infusions are determined by the study protocol.
Participants may also receive other medications such as mycophenolate mofetil in capsule form, which is taken orally, and infliximab, administered intravenously, depending on the study requirements.
Step 4
Monitoring and assessments
Regular monitoring is conducted to assess the progression of the disease and the body's response to the treatment. This includes imaging tests and blood tests.
Participants are evaluated for progression-free survival (PFS), which measures the time during and after treatment that the cancer does not worsen.
Step 5
Follow-up
After completing the treatment phase, participants enter a follow-up period where their health and any long-term effects of the treatment are monitored.
The study aims to determine the overall survival rate and the duration of response to the treatment.

Who can join the trial?

10 criteria

Must be female.
Must be able to provide signed informed consent, which means agreeing to participate after understanding the study details.
Must be at least 15 years old at the time of screening.
Must weigh more than 35 kg (about 77 pounds).
Must have a specific type of cervical cancer, which is confirmed by a test called a histological test. This includes certain stages of cervical cancer with lymph node involvement.
Initial tests to determine the stage of cancer must have been done no more than 42 days before starting the first treatment.
Must provide a sample of the tumor to check for PD-L1 expression, which is a specific protein that might be present in the cancer.
Must not have cancer that has worsened after a treatment called CCRT (a combination of chemotherapy and radiation therapy). If the disease is still present after this treatment, there should be no other available treatments that could cure it.
Must have a WHO/ECOG performance status of 0 or 1, which means being fully active or having some symptoms but still able to do light work.
Must have adequate organ and bone marrow function, meaning the organs and bone marrow are working well enough to participate in the study.

Who cannot join the trial?

4 criteria

Patients who do not have locally advanced cervical cancer cannot participate. This means the cancer is in the cervix and may have spread to nearby tissues but not to distant parts of the body.
Only females can participate, so males are excluded.
Participants must have a specific protein called PD-L1 in their cancer cells. If this protein is not present, they cannot join the study.
Individuals who are considered part of a vulnerable population are excluded. This term refers to groups of people who might need special protection or care, such as children, pregnant women, or those unable to make decisions for themselves.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Azienda Ospedaliera Ordine Mauriziano Di Torino
Turin, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Volrustomig is a medication being studied for its potential to help women with high-risk, locally advanced cervical cancer. This trial is looking at how well volrustomig works in patients who have not seen their cancer progress after receiving a combination of platinum-based chemotherapy and radiation therapy. The main goal is to see if volrustomig can improve progression-free survival, especially in patients with a specific protein expression called PD-L1.

What is already known about the treatment

Volrustomig – Volrustomig is administered intravenously and is currently being studied in clinical trials for its potential use in treating locally advanced cervical cancer. It is in the experimental phase and not yet widely recognized in medical literature as a standard treatment. The main therapeutic indication for volrustomig is for women with high-risk locally advanced cervical cancer who have not progressed following platinum-based, concurrent chemoradiation therapy. At the molecular level, volrustomig works by targeting and inhibiting the PD-L1 protein, which can help the immune system recognize and attack cancer cells. It is classified as an immunotherapy agent.

Investigated diseases

Locally Advanced Cervical Cancer – This is a stage of cervical cancer where the disease has spread beyond the cervix to nearby tissues but not to distant parts of the body. It often involves the pelvic wall or the lower part of the vagina. Symptoms may include abnormal vaginal bleeding, pelvic pain, or pain during intercourse. As the cancer progresses, it may cause more severe symptoms and affect nearby organs. The progression can vary, with some cases advancing more rapidly than others. Early detection and monitoring are crucial for managing the disease effectively.