Recruiting

Study on the Safety and Effectiveness of Volrustomig with FOLFIRI and Bevacizumab for Colorectal Cancer Patients Without Liver Metastases

Verified siteRegistered drugNo placebo

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 treatments for colorectal cancer, a type of cancer that affects the colon or rectum. The study aims to evaluate the safety and effectiveness of new treatment combinations. One of the main treatments being tested is a medication called volrustomig, also known by its code name MEDI5752. Volrustomig is a type of protein designed to help the immune system target cancer cells. It will be used in combination with a chemotherapy regimen called FOLFIRI and a medication called bevacizumab, which is a monoclonal antibody that helps prevent the growth of blood vessels that feed tumors.

Participants in the study will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will compare the effects of the combination of volrustomig, FOLFIRI, and bevacizumab to the effects of FOLFIRI and bevacizumab alone. The goal is to see if adding volrustomig improves outcomes for patients with colorectal cancer who do not have liver metastases, which are cancerous growths that have spread to the liver.

The study will take place over several months, with regular monitoring to assess how well the treatments are working and to check for any side effects. Participants will undergo various tests and assessments to track their progress and ensure their safety throughout the trial. The ultimate aim is to find more effective treatment options for people with colorectal cancer, improving their quality of life and potentially extending survival.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes a review of medical history and a physical examination.
Blood tests and imaging studies may be performed to ensure there is no evidence of liver metastases and to confirm the presence of colorectal cancer.
Step 2
Treatment plan discussion
The treatment plan will be discussed, including the medications involved and their administration methods.
Participants will receive a combination of medications: volrustomig, FOLFIRI (which includes fluorouracil, irinotecan hydrochloride trihydrate, and folinic acid), and bevacizumab. These medications are administered through an intravenous infusion, which means they are given directly into a vein.
Step 3
Medication administration
The medications will be administered in cycles. Each cycle typically lasts two weeks, with specific days designated for receiving the infusions.
The exact dosage and schedule will be determined by the study team based on individual health status and response to treatment.
Step 4
Regular monitoring
Regular monitoring will occur throughout the study to assess the safety and effectiveness of the treatment.
This includes routine blood tests, imaging studies, and physical examinations to track progress and detect any side effects.
Step 5
Follow-up visits
Follow-up visits will be scheduled to evaluate the overall health and response to the treatment.
These visits will help determine the progression-free survival, which is the time during and after treatment that the cancer does not get worse.
Step 6
End of treatment evaluation
At the end of the treatment period, a comprehensive evaluation will be conducted to assess the overall outcomes.
This will include a final review of all test results and a discussion of the next steps in care, if necessary.

Who can join the trial?

16 criteria

Participant must be 18 years or older at the time of signing the consent form.
Must have a confirmed diagnosis of colorectal adenocarcinoma, which is a type of colorectal cancer.
Must provide a tumor sample as per standard procedures.
All races, genders, and ethnic groups are eligible to participate.
Must have measurable disease according to specific medical criteria (RECIST 1.1).
Must have an ECOG performance status of 0 or 1, which means the participant is fully active or has some symptoms but does not require bed rest.
Must have a life expectancy of at least 12 weeks at the time of screening.
Must be capable of giving signed informed consent and comply with the study requirements.
Must provide a signed and dated written consent form before any study-specific procedures.
Must provide signed consent for optional genetic research, if participating in that part of the study.
Must have metastatic or recurrent colorectal adenocarcinoma with no evidence of liver metastases, which means the cancer has spread but not to the liver.
Must not have had prior systemic therapy for metastatic colorectal cancer, except for certain chemotherapy given more than 6 months before the diagnosis of recurrent or metastatic disease.
Must have a known pMMR/MSS status, which refers to specific genetic characteristics of the cancer.
Must have adequate organ and bone marrow function without recent transfusions or growth factor support.
Must weigh more than 35 kg (about 77 pounds) at screening and at randomization.
Must use contraception as per local regulations if applicable.

Who cannot join the trial?

3 criteria

Patients with **liver metastases** cannot participate. Liver metastases means that the cancer has spread to the liver.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which may include groups like children or those unable to give consent, cannot participate.

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

ASST Grande Ospedale Metropolitano Niguarda
Verified
Milan, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Istituto Oncologico Veneto
Responsive
Padua, 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 an experimental medication being tested in this clinical trial. It is being studied to see if it can help treat colorectal cancer when used together with other cancer treatments. The goal is to find out if adding volrustomig can improve the effectiveness of the existing treatment plan for patients who do not have cancer spread to their liver.
FOLFIRI
is a combination of chemotherapy drugs used to treat colorectal cancer. It includes three different medications that work together to stop cancer cells from growing and dividing. This combination is often used when the cancer has spread to other parts of the body.
Bevacizumab
is a medication that helps stop the growth of new blood vessels that tumors need to grow. By blocking these blood vessels, bevacizumab can help slow down or stop the growth of cancer. It is used in combination with other cancer treatments to improve their effectiveness.

What is already known about the treatment

Volrustomig – Volrustomig is administered in combination with FOLFIRI and bevacizumab, typically through intravenous infusion, which means it is delivered directly into the bloodstream via a vein. It is currently being studied in clinical trials for its potential use in treating colorectal cancer, specifically in patients without liver metastases. The main goal of using volrustomig is to improve progression-free survival, which means extending the time patients live without the cancer worsening. At the molecular level, volrustomig works by targeting specific pathways involved in cancer cell growth and survival, although the exact mechanism is still under investigation. It falls under the pharmacological classification of targeted cancer therapies, which are designed to interfere with specific molecules involved in tumor growth and progression.

Investigated diseases

Colorectal cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. As the cancer progresses, it can invade and destroy normal tissue nearby and may spread to other parts of the body. The progression of colorectal cancer can vary, with some cases growing slowly over several years. Symptoms may not appear until the cancer has advanced, making regular screenings important for early detection.