Study on the Safety and Effectiveness of Magrolimab with Bevacizumab and Drug Combination for Patients with Advanced Metastatic Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying the treatment of metastatic colorectal cancer, which is a type of cancer that has spread from the colon or rectum to other parts of the body. The study is evaluating the safety and effectiveness of a new treatment combination. The treatment involves a medication called Magrolimab, which is a humanized monoclonal antibody targeting a protein called CD47, used in combination with other medications: Bevacizumab, a drug that inhibits the growth of blood vessels in tumors, and a chemotherapy regimen known as FOLFIRI. FOLFIRI includes three drugs: 5-fluorouracil, irinotecan, and leucovorin, which work together to stop cancer cells from growing and dividing.

The purpose of this study is to assess how well the combination of Magrolimab, Bevacizumab, and FOLFIRI works in patients who have already received treatment for their advanced cancer but are not eligible for certain other therapies. Participants in the study will be randomly assigned to receive either the new combination treatment or the standard treatment of Bevacizumab and FOLFIRI. The study will monitor the participants over a period of time to evaluate the progression of the disease and any side effects experienced.

Throughout the study, participants will receive the medications through intravenous infusions, which means the drugs are delivered directly into the bloodstream through a vein. The study aims to provide valuable information on whether the addition of Magrolimab to the existing treatment regimen can improve outcomes for patients with metastatic colorectal cancer. The trial will help determine the best dose and assess the safety of the new treatment combination.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of magrolimab, bevacizumab, and FOLFIRI (a combination of fluorouracil, irinotecan, and leucovorin). The other group will receive bevacizumab and FOLFIRI without magrolimab.

2 treatment administration

You will receive the medications through an intravenous infusion, which means the medicine will be given directly into your vein. The specific dosages and frequency of administration will be determined by the study team based on your individual needs and the study protocol.

3 monitoring and follow-up

Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and other necessary assessments to ensure your safety and to evaluate the effectiveness of the treatment.

You will be asked to report any side effects or changes in your health to the study team immediately.

4 end of treatment

The treatment phase will continue until the study’s end date or until it is determined that the treatment is no longer beneficial for you. The estimated end date for the study is September 15, 2024.

5 final assessment

At the end of the study, a final assessment will be conducted to evaluate your overall health and the outcomes of the treatment. This will help in understanding the effectiveness and safety of the treatment combination.

Who Can Join the Study?

Individuals who have been previously treated for inoperable metastatic colorectal cancer (mCRC). This means the cancer has spread and cannot be removed by surgery.
Individuals who cannot receive checkpoint inhibitor therapy. This is a type of treatment that helps the immune system fight cancer.
Individuals with cancer that started in the colon or rectum and has been confirmed by a doctor. This does not include cancer that started in the appendix or anal canal.
Individuals whose cancer has gotten worse after at least one previous treatment. This treatment must have included certain types of chemotherapy and possibly other drugs like bevacizumab, cetuximab, or panitumumab.
Individuals with measurable disease. This means the cancer can be measured in size using specific criteria.
Individuals with an ECOG performance status of 0 or 1. This is a scale that measures how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
Individuals with a life expectancy of at least 12 weeks.
Individuals with adequate blood counts. This means having enough red blood cells, white blood cells, and platelets.
Individuals with adequate liver function. This means the liver is working well enough.
Individuals with adequate renal function. This means the kidneys are working well enough.
Other criteria may apply as defined by the study protocol.

Who Cannot Join the Study?

Patients who have not been previously treated for their advanced colorectal cancer cannot participate.
Patients who have a different type of cancer other than metastatic colorectal cancer are not eligible.
Patients with a history of severe allergic reactions to any of the study drugs cannot join the trial.
Patients with uncontrolled medical conditions, such as high blood pressure or diabetes, are not allowed to participate.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are currently participating in another clinical trial are not eligible.
Patients with active infections, such as hepatitis or HIV, cannot join the trial.
Patients who have had a major surgery within the last 4 weeks are not allowed to participate.
Patients with a history of heart problems, such as a heart attack or heart failure, are not eligible.
Patients who have received certain treatments, like chemotherapy or radiation, within a specific time frame before the study starts cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Universita’ Di Pisa	Pisa	Italy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
IHFB Cognacq Jay	Levallois-Perret	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
Hopital De Libramont	Libramont-Chevigny	Belgium
Hsyjjhz Jfmckvnu	Haine-Saint-Paul	Belgium
Ioirekhm Rugwoxyzd Pya Lz Sdrydx Dzx Tlzmzh Dkdt Atnevcs Isfk Sngkzw	Meldola	Italy
Btaclbpf Ubtxgpasxi Hwnkefrl Ckesbl	Besançon	France
Czxpvy Hmppkzmoxmw Rtctycmg Umjyrobirzdrn Dd Tdadq	Tours	France
Cgojpr Lgxj Buphiv	Lyon	France
Ixrpvgiq Crvlju Dimevrlssyhbriguy	L'hospitalet De Llobregat	Spain
Hsqwflmv Vhoi dgbmgpdt	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.03.2023
France	Not recruiting	01.03.2023
Germany	Not recruiting	01.03.2023
Italy	Not recruiting	01.03.2023
Spain	Not recruiting	01.03.2023

Trial locations

Investigated drugs:

Magrolimab is a medication being studied for its potential to help the immune system fight cancer. It works by blocking a specific signal that cancer cells use to avoid being attacked by the body’s immune cells. In this trial, researchers are looking at how well magrolimab works when combined with other cancer treatments for people with advanced colorectal cancer that cannot be removed by surgery.

Bevacizumab is a medication that helps to 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. In this trial, it is used in combination with other treatments to see if it can improve outcomes for patients with advanced colorectal cancer.

FOLFIRI is a combination of three different chemotherapy drugs used to treat colorectal cancer. It includes 5-fluorouracil, irinotecan, and leucovorin. 5-fluorouracil works by interfering with the cancer cell’s ability to make DNA, which is necessary for cell growth. Irinotecan helps to stop cancer cells from dividing and growing. Leucovorin is used to enhance the effectiveness of 5-fluorouracil. Together, these medications aim to reduce the size of tumors and slow the progression of cancer.

Investigated diseases:

Colorectal cancer metastatic

Metastatic Colorectal Cancer – Metastatic colorectal cancer is a type of cancer that originates in the colon or rectum and has spread to other parts of the body. It typically begins as a growth, called a polyp, on the inner lining of the colon or rectum, which can become cancerous over time. As the cancer progresses, it can invade nearby tissues and spread to distant organs, most commonly the liver and lungs. The disease may cause symptoms such as changes in bowel habits, blood in the stool, abdominal pain, and weight loss. The progression of metastatic colorectal cancer can vary, with some cases advancing more rapidly than others. The spread of cancer cells to other parts of the body is a key characteristic of this disease.

Trial ID:

2022-500177-13-00

Protocol code:

GS-US-587-6156

NCT ID:

NCT05330429

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of Magrolimab with Bevacizumab and Drug Combination for Patients with Advanced Metastatic Colorectal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?