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Study on the Safety and Effectiveness of Volrustomig with a Drug Combination for Patients with Solid Tumors

Verified siteRegistered drugNo placebo

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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 the effects of a new treatment for people with solid tumors, which are a type of cancer that forms in solid organs or tissues. The main treatment being tested is called volrustomig, also known by its code name MEDI5752. This treatment is a special type of protein designed to help the immune system fight cancer. In this study, volrustomig will be used in combination with other cancer-fighting drugs, including pemetrexed, carboplatin, mycophenolate mofetil, and infliximab.

The purpose of the study is to evaluate how safe and tolerable volrustomig is when used with these other medications, and to see how well it works in treating solid tumors. Participants will receive these treatments through an infusion, which means the medication is given directly into the bloodstream through a vein. The study will monitor participants over a period of time to observe any side effects and to measure the effectiveness of the treatment in reducing or controlling the tumors.

Throughout the study, researchers will collect information on how the body processes volrustomig and how the immune system responds to it. This includes checking the levels of the drug in the blood and looking for any signs that the body is reacting against it. The study aims to provide valuable insights into the potential benefits and risks of using volrustomig in combination with other cancer treatments for people with solid tumors.

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
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes checking the **Eastern Cooperative Oncology Group (ECOG) performance status**, ensuring a life expectancy of at least 12 weeks, and verifying adequate organ and bone marrow function.
Body weight will be measured to ensure it is at least 35 kilograms. A review of medical history will confirm the absence of specific genetic mutations and the presence of at least one measurable tumor lesion.
Step 2
Treatment initiation
The treatment phase begins with the administration of **volrustomig** in combination with other anticancer drugs. The specific medications include **pemetrexed**, **mycophenolate mofetil**, **carboplatin**, and **infliximab**.
These medications are administered through different methods: **intravenous infusion** for pemetrexed, carboplatin, and infliximab, and **oral capsules** for mycophenolate mofetil.
Step 3
Ongoing treatment
The treatment will continue over a specified period, with regular administration of the medications. The frequency and dosage will be determined by the study protocol and the medical team overseeing the trial.
Participants will receive regular monitoring to assess the safety and tolerability of the treatment, as well as its effectiveness in reducing tumor size.
Step 4
Regular assessments
Throughout the trial, regular assessments will be conducted to monitor health status and treatment response. This includes blood tests, imaging scans, and other necessary evaluations.
The primary goal is to ensure the safety of the treatment and to measure its impact on tumor growth.
Step 5
Completion of trial
Upon completion of the treatment phase, a final assessment will be conducted to evaluate the overall response to the treatment.
Participants will be informed of the results and any further steps or follow-up care that may be necessary.

Who can join the trial?

11 criteria

Must have a solid tumor, which is a type of cancer that forms in body tissues.
Must have an ECOG performance status of 0 or 1, meaning you are fully active or have some symptoms but can still do light work.
Must have a life expectancy of at least 12 weeks.
Must have adequate organ and bone marrow function, meaning your organs and bone marrow are working well enough.
Must weigh at least 35 kilograms (about 77 pounds).
Must have a type of lung cancer called NSQ NSCLC, which is a non-squamous non-small cell lung cancer.
Must not have certain genetic changes in the cancer, like EGFR mutations, which are changes in a gene that can affect cancer growth.
Must not have other genetic changes that can be treated with specific drugs available locally.
Must have at least one measurable lesion, which is a tumor that can be measured and has not been treated with radiation before. It should be at least 10 millimeters in size.
Open to both male and female participants.
Participants can be from vulnerable populations, which may include groups like children or the elderly.

Who cannot join the trial?

10 criteria

Patients with any medical condition other than solid tumors cannot participate. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not willing or able to follow the study procedures cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients with certain medical conditions that might interfere with the study cannot participate.
Patients who are taking medications that might interfere with the study cannot participate.
Patients with a history of allergic reactions to the study drugs cannot participate.
Patients with severe or uncontrolled illnesses cannot participate.
Patients with a history of substance abuse or addiction cannot participate.

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Verified sites

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

Athens Medical Center S.A.
Verified
Thessaloniki, Greece
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Verified
Naples, Italy
Azienda Sanitaria Universitaria Friuli Centrale
Verified
Udine, Italy

Trial locations

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Investigated drugs

Volrustomig is a medication being studied for its potential to help treat certain types of solid tumors. In this clinical trial, researchers are looking at how safe and tolerable this medication is when used with other cancer-fighting drugs. They are also interested in seeing how well it works in shrinking or controlling tumors. Volrustomig is given to patients to see if it can help the body's immune system fight cancer more effectively.

What is already known about the treatment

Volrustomig – Volrustomig is administered as an injection, typically given in a healthcare setting. It is currently being studied in clinical trials for its potential use in treating solid tumors, which are abnormal masses of tissue that usually do not contain cysts or liquid areas. The main goal of using volrustomig is to evaluate its safety and effectiveness when combined with other cancer-fighting drugs. At the molecular level, volrustomig works by targeting specific pathways in cancer cells to inhibit their growth and spread. It is classified as an anticancer agent, specifically designed to enhance the body's immune response against tumor cells.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, and bones. These tumors are characterized by the uncontrolled growth of cells that form a solid mass. As they progress, they can invade nearby tissues and organs, potentially disrupting their normal function. Solid tumors can vary in size and may grow slowly or rapidly, depending on their type and location. They can also spread to other parts of the body through the bloodstream or lymphatic system, a process known as metastasis.