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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Centre Hospitalier Universitaire De Poitiers Poitiers France
Isala Klinieken Stichting Zwolle The Netherlands
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Philipps-Universitaet Marburg Marburg Germany
Universita’ Di Pisa Pisa Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Netherlands Cancer Institute Amsterdam The Netherlands
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Igbvownh Rkuskybg Ds Cnvnyn Dc Mhjbevhkpth Montpellier France
Uxlyjarltatdxybuuspfv Ewskf Abj Essen Germany
Hvnzhief Ukusauzhhawre Macipkw Dv Vbqvxthcll Santander Spain
Iqixzdpn dn Cglrbqfwgsbd Hsxululljqv Uilsbwgiodkwv dz Syoiv Eorodvu (rrowvyy Saint Priest En Jarez France
Hlwqilug Vhfm dxpxgdup Barcelona Spain

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

Trial status

Country Status Recruitment Start
France France
Recruiting
31.03.2025
Germany Germany
Recruiting
31.03.2025
Italy Italy
Recruiting
31.03.2025
Spain Spain
Recruiting
31.03.2025
The Netherlands The Netherlands
Recruiting
31.03.2025

Trial locations

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.

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.

Trial ID:
2024-518469-84-00
Protocol code:
​​D798VC00001​
Trial Phase:
Therapeutic exploratory (Phase II)

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