Study of Volrustomig for Patients with Advanced Solid Tumors with Mature Tertiary Lymphoid Structures

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called volrustomig (also known by its code name MEDI5752) on patients with advanced forms of cancer known as solid tumors. These tumors are characterized by the presence of special structures called mature tertiary lymphoid structures, which are involved in the body’s immune response. The trial aims to evaluate how well volrustomig works in treating these types of tumors.

The study involves two groups of patients. The first group includes patients who have not previously received certain types of immune therapy, while the second group consists of patients who have been treated with immune therapies targeting proteins called PD1 and PDL1 but have developed resistance to them. The treatment, volrustomig, is administered as a solution through an intravenous infusion, which means it is given directly into the bloodstream through a vein. The study will assess the treatment’s effectiveness by observing changes in the size of the tumors and monitoring the patients’ overall health over time.

The purpose of this trial is to determine the antitumor activity of volrustomig in these specific patient groups. The study will last for several years, during which patients will receive the treatment and be regularly monitored for any changes in their condition. The trial will also gather information on the safety of volrustomig and how it affects the tumor environment, including the presence of immune cells and other markers that may influence the treatment outcome. This research is important for understanding how new therapies can be used to treat advanced solid tumors and improve patient outcomes.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, weight, and medical history.

A negative pregnancy test is required for women of childbearing potential within 7 days prior to study entry.

2 initial assessment

An initial assessment is conducted to evaluate the current health status, including blood tests and imaging to confirm the presence of mature tertiary lymphoid structures in tumors.

Baseline measurements are taken to assess the disease according to RECIST v1.1 criteria.

3 treatment administration

The treatment involves the administration of volrustomig, a solution for infusion, given intravenously.

The dosage and frequency of administration are determined by the study protocol and adjusted based on individual response and tolerance.

4 ongoing monitoring

Regular monitoring is conducted to assess the response to treatment, including imaging and laboratory tests.

The safety profile of volrustomig is evaluated continuously to ensure patient well-being.

5 response evaluation

The antitumor activity is assessed based on the objective response rate, which measures the reduction in tumor size.

Additional evaluations include the duration of response and progression-free survival over 1 and 2 years.

6 study completion

The study is estimated to conclude by October 2027, with final assessments conducted to determine overall survival and clinical benefit.

Participants are provided with a summary of their treatment outcomes and any further recommendations.

Who Can Join the Study?

Must have a confirmed solid tumor. This means the tumor has been checked and identified by a doctor.
Must have an ECOG performance status of 0 or 1. This is a scale that measures how well you can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Must have a life expectancy of more than 3 months.
Must have adequate blood, kidney, liver, and heart function. This includes specific levels for blood cells, liver enzymes, and heart function, which will be checked by your doctor.
Must have disease progression after previous treatment or be in the first line of treatment for certain cancers like lung, pancreatic, or breast cancer. You should not have had more than three different treatments for advanced cancer.
Must have recovered from any side effects of previous treatments to a mild level, except for hair loss. If you had certain immune-related treatments before, you can join if your side effects are mild and controlled with medication.
Women who can have children must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for 90 days after.
Men must agree to use acceptable birth control during the study and for 90 days after.
Must provide written consent to participate in the study.
Must have social security in compliance with French law.
Must be either IO-naïve (not previously treated with certain immune therapies) or have secondary resistance to PD1/PDL1 inhibitors, meaning the cancer initially responded to treatment but then stopped responding.
Must have mature tertiary lymphoid structures in the tumor, which are specific immune system features, confirmed by a central review if not already confirmed.
Must have advanced unresectable or metastatic solid disease, meaning the cancer cannot be removed by surgery and has spread to other parts of the body.
Must have measurable disease according to specific criteria, meaning the tumor can be measured and tracked over time.
Must have at least one tumor site that can be biopsied for research purposes.
Must be 18 years or older.
Must have a body weight of more than 35 kg (about 77 pounds).

Who Cannot Join the Study?

Participants who have not been diagnosed with metastatic (advanced) solid tumors. This means the cancer has spread to other parts of the body.
Participants who are not adults. This trial is only for adult participants.
Participants who are not able to understand or follow the study procedures.
Participants who are pregnant or breastfeeding.
Participants who have other serious health conditions that could interfere with the study.
Participants who have had another cancer treatment recently that might affect the study results.
Participants who have allergies to the study medication or its ingredients.
Participants who are currently participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Iyvrazlo Bxdmydlq	Bordeaux	France
Chavbz Ogxip Ltbygch	Lille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	15.12.2024

Trial locations

Investigated drugs:

Volrustomig

Volrustomig (MEDI5752) is an investigational medication being studied for its potential to treat certain types of solid tumors. It is being evaluated in patients who have specific structures in their tumors known as mature tertiary lymphoid structures. The trial aims to assess how well this medication can reduce or eliminate tumors in patients who have not previously received certain types of immune therapy, as well as in those who have already been treated with PD1 or PDL1 inhibitors.

Metastatic Solid Tumors – Metastatic solid tumors are cancers that have spread from their original site to other parts of the body. These tumors can originate from various organs, such as the breast, lung, or colon, and are characterized by their ability to invade surrounding tissues and form new tumors in distant organs. The progression of metastatic solid tumors involves the detachment of cancer cells from the primary tumor, their travel through the bloodstream or lymphatic system, and the establishment of new tumors in other organs. This spread can lead to a variety of symptoms depending on the organs affected. The growth and spread of these tumors can be influenced by factors such as the tumor’s genetic makeup and the body’s immune response. Understanding the behavior of metastatic solid tumors is crucial for developing effective treatment strategies.

Trial ID:

2023-503451-94-00

Protocol code:

2023-01

NCT ID:

NCT05888857

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Volrustomig for Patients with Advanced Solid Tumors with Mature Tertiary Lymphoid Structures

What is this study about?

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