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Study of Monalizumab and Volrustomig for Patients with MSI and/or dMMR Metastatic Cancer

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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 patients with a type of cancer known as metastatic cancer that has specific characteristics called MSI (microsatellite instability) and/or dMMR (deficient mismatch repair). These characteristics can make the cancer more challenging to treat. The study will use two medications: Monalizumab and MEDI5752, which is also known as volrustomig. Monalizumab is a type of protein that helps the immune system fight cancer, and MEDI5752 is a specially designed antibody that targets certain proteins on cancer cells to help the immune system attack them.

The purpose of this study is to see how well these two medications work together in treating this type of cancer. Participants in the study will receive these medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will last for up to 24 weeks, during which time the response of the cancer to the treatment will be closely monitored. This will help researchers understand how effective the treatment is and what side effects might occur.

Throughout the study, participants will have regular check-ups and tests, such as MRI scans, to track the progress of the treatment. The study aims to find out if the combination of Monalizumab and MEDI5752 can help control the cancer and improve the quality of life for patients with this challenging condition. Participants will be monitored for any side effects to ensure their safety during the trial.

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, the patient will provide a signed and dated informed consent form, indicating willingness to comply with all study procedures and availability for the study duration.
The patient must have at least one measurable lesion as assessed by CT-scan or MRI, and a representative tumor specimen must be available for research purposes.
Step 2
Initial assessments
Initial assessments will include a baseline-corrected QT interval measurement, hematologic and end-organ function tests, and a pregnancy test for females of childbearing potential.
The patient must meet specific health criteria, including adequate blood cell counts, renal function, and liver function.
Step 3
Treatment administration
The treatment involves the administration of two medications: monalizumab and MEDI5752, both given as a solution for infusion through intravenous perfusion.
The frequency and dosage of the medications will be determined by the study protocol, and the treatment will continue as specified in the study guidelines.
Step 4
Monitoring and follow-up
Throughout the study, the patient will undergo regular monitoring to assess the safety and effectiveness of the treatment. This includes recording any adverse events and conducting necessary tests such as electrocardiograms.
Tumor response will be evaluated using specific criteria, and the patient's overall health and progression-free survival will be monitored.
Step 5
End of treatment
The study is expected to conclude by December 11, 2028. At the end of the treatment period, the patient's response to the treatment will be assessed, and any necessary follow-up care will be provided.
The patient will be monitored for any long-term effects of the treatment and overall survival will be recorded.

Who can join the trial?

24 criteria

Sign a consent form and agree to follow all study procedures and be available for the study duration.
Have at least one measurable tumor that can be seen and measured using a CT scan or MRI. If the tumor is in an area that was previously treated with radiation, it must show clear growth and be measurable.
Provide a sample of the tumor for research purposes. This can be a block of tissue or slides from the tumor.
Have a heart test result called QT interval that is less than 470 milliseconds.
Have good blood and organ function, shown by specific blood test results:
White blood cells greater than 2000 per microliter.
Neutrophils greater than 1500 per microliter.
Platelets greater than 100,000 per microliter.
Hemoglobin greater than 9.0 grams per deciliter.
Kidney function with creatinine level less than 150 micromoles per liter and creatinine clearance at least 45 milliliters per minute.
Liver function with specific limits on bilirubin, alkaline phosphatase, ALT, and AST levels.
Blood clotting tests within normal limits unless on blood-thinning medication.
Women who can have children must have a negative pregnancy test and use effective birth control during the study and for 140 days after the last treatment.
Women must not breastfeed or donate eggs during the study and for 140 days after the last treatment.
Men who are sexually active with women who can have children must use a condom with spermicide during the study and for 140 days after the last treatment. It is recommended that their partners also use effective birth control.
Be registered in a national health care system.
Be at least 18 years old.
Weigh more than 35 kilograms (about 77 pounds).
Have a performance status of 0 or 1, meaning you are fully active or have some symptoms but can still do light work.
Have a life expectancy of at least 12 weeks.
Have a confirmed type of cancer called carcinoma.
Have a specific tumor status called dMMR or MSI, which involves certain protein expressions or markers.
Have advanced or metastatic cancer that cannot be completely removed by surgery.
Have cancer that cannot be removed or has spread, and have tried at least one treatment that did not work or was not tolerated, with no other satisfactory treatment options available.

Who cannot join the trial?

4 criteria

Patients who have a different type of cancer that is not the focus of this study.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who do not meet the specific medical conditions required for the study.

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Verified sites

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

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Besancon University Hospital Center
Besançon, France
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Centre Hospitalier Universitaire De Poitiers
Poitiers, France
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Centre Leon Berard
Lyon, France

Trial locations

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Investigated drugs

Monalizumab
is a medication being studied for its potential to help the immune system fight cancer. It works by blocking certain proteins that can stop the immune system from attacking cancer cells. In this trial, it is being tested to see if it can improve the response of patients with specific types of metastatic cancer.
MEDI5752
is another medication involved in this trial. It is designed to enhance the body's immune response against cancer cells. By targeting specific pathways, it aims to boost the immune system's ability to recognize and destroy cancer cells. This trial is exploring how well it works in combination with Monalizumab for patients with certain metastatic cancers.

What is already known about the treatment

Monalizumab
Monalizumab is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating certain types of metastatic cancer, particularly those with specific genetic markers like MSI or dMMR. The medication works by targeting and blocking specific proteins on immune cells, which helps the immune system recognize and attack cancer cells more effectively. Monalizumab is classified as an immune checkpoint inhibitor, a type of drug that helps to boost the body's natural defenses against cancer.
MEDI5752
MEDI5752 is also administered intravenously and is under investigation in clinical trials for its potential to treat metastatic cancer with MSI or dMMR characteristics. This medication functions by simultaneously targeting two immune checkpoint pathways, enhancing the immune system's ability to detect and destroy cancer cells. It belongs to the pharmacological class of bispecific antibodies, which are designed to engage two different targets at once, potentially offering a more robust anti-cancer response.

Investigated diseases

Metastatic Cancer – Metastatic cancer occurs when cancer cells spread from the primary site to other parts of the body. This process involves cancer cells breaking away from the original tumor, traveling through the bloodstream or lymphatic system, and forming new tumors in other organs or tissues. The progression of metastatic cancer can vary depending on the type of primary cancer and the organs affected. Symptoms may differ based on the location of the metastases, and the disease can affect multiple systems in the body. The spread of cancer cells can lead to complications and changes in the function of affected organs. Understanding the behavior of metastatic cancer is crucial for developing effective treatment strategies.