Active not recruitingNAINTERVENTIONAL

Immunotherapy Clearance and Phenotype of Circulating Tumor Cells in Lung and Head and Neck Cancers

This study, called MADMAS, aims to understand why immunotherapy works for some people with advanced lung or head and neck cancers but not for others. Immunotherapy is a common cancer treatment, but its success can vary greatly. Researchers believe that certain markers found on cancer cells circulating in the blood, particularly one called PD-L1, might hold clues. This study will track how the body processes immunotherapy and how the number of these circulating cancer cells with PD-L1 changes during treatment. By doing this, scientists hope to find better ways to predict who will benefit most from immunotherapy in the future. Participants will have blood samples taken at different times during their normal cancer treatment.

At a glance

Status

Active not recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

27 Oct 2021

Estimated completion

11 Dec 2026

Metastatic NSCLC Metastatic Head and Neck Cancer

What is this study about?

Immunotherapy is a type of cancer treatment that helps your body's own immune system fight cancer cells. It's used for many different cancers, including advanced lung and head and neck cancers. While it can be very effective, it doesn't work for everyone, and doctors are trying to understand why.

This study is trying to figure out what makes immunotherapy successful for some patients and why others might not respond as well. We know that cancer cells sometimes break away from the main tumor and travel through the bloodstream. These are called 'circulating tumor cells' (CTCs). These cells carry information about the tumor, including a marker called PD-L1. Researchers think that changes in these markers on CTCs might tell us how well immunotherapy is working.

The MADMAS study will look at two main things: how quickly immunotherapy is cleared from a patient's body and how the number of circulating tumor cells with the PD-L1 marker changes after starting treatment. By carefully measuring these factors in blood samples taken at different times, the researchers hope to find a link between these measurements and how patients respond to their immunotherapy. This could help doctors in the future choose the best treatments for each patient.

Key takeaways

This study investigates why immunotherapy works for some lung and head & neck cancer patients but not others.
Researchers will collect blood samples to look at cancer cells and how immunotherapy clears from the body.
The goal is to find better ways to predict who will benefit most from immunotherapy.
Participation involves no new treatments, just a few extra blood tests.
The findings could lead to more personalised cancer care in the future.

Who may be eligible?

This study is looking for adults diagnosed with certain types of advanced lung cancer (non-small cell lung cancer) or specific head and neck cancers that have spread. You would need to be planning to start immunotherapy, sometimes along with chemotherapy, as your first treatment for the advanced cancer.

To join, you must weigh at least 48 kg and be part of a social insurance scheme. Important information about your tumour's PD-L1 status needs to be available from your doctor. You also can't have been pregnant or breastfeeding during the study, or have certain other medical conditions, or have recently received immunotherapy for head and neck cancer if you have that type of cancer.

Everyone who takes part must be able to give their written permission (consent) and not be under guardianship or psychiatric care. If you've had other cancers many years ago that have been fully treated, you might still be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult with advanced lung or head and neck cancer?
Are you starting immunotherapy (with or without chemotherapy) as your first treatment for the advanced cancer?
Do you weigh at least 48 kg?
Is information about your tumour's PD-L1 status available?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be given any new or experimental medications. The study focuses on collecting information through blood samples while you receive your standard immunotherapy treatment. You will have blood samples taken at three different times:

* Before you start your first immunotherapy treatment. * Before your second immunotherapy treatment. * Before your third immunotherapy treatment.

These blood draws will be scheduled alongside your regular hospital visits for treatment. Each blood draw is a simple procedure, similar to giving blood for other medical tests. The study does not involve any additional visits specifically for research purposes. The total duration of your participation will be for the period when these three blood samples are collected, typically over a few weeks to a couple of months, depending on your treatment schedule.

Potential risks and benefits

Taking part in this study means you'll have extra blood samples taken. The main risk associated with this is slight discomfort, bruising, or a small risk of infection at the site of the blood draw. There are no direct medical benefits for you from taking part, as you will be receiving your standard treatment. However, the information gathered could help researchers understand immunotherapy better and potentially benefit future patients with similar cancers by leading to more tailored treatments. You are free to withdraw from the study at any time without this affecting your medical care.

Locations (2)

Croix Rousse Hospital
Verified postcode
Lyon, France
Lyon Sud Hospital
Verified postcode
Pierre-Bénite, France

Common questions

What is immunotherapy?

Immunotherapy is a type of cancer treatment that helps your body's own immune system find and kill cancer cells.

What are 'circulating tumor cells' (CTCs)?

These are cancer cells that have broken away from the main tumour and are travelling in your bloodstream. They contain useful information about the cancer.

Will I receive a different treatment if I join this study?

No, you will receive your standard immunotherapy treatment as planned by your medical team. This study only involves taking extra blood samples.

How many blood samples will be taken?

Three blood samples will be taken: one before your first immunotherapy, one before your second, and one before your third treatment.

Will this study directly benefit me?

While there's no direct benefit to you, your participation will help researchers learn more about how immunotherapy works, which could improve treatments for others in the future.