Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 (Anti–LAG-3) and INCAGN02390 (Anti–TIM-3) as First-Line Treatment in Participants With PD-L1–Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

This is a Phase 2 clinical trial looking into new treatment options for people diagnosed with advanced squamous cell carcinoma of the head and neck. This type of cancer has either come back or spread, and has a specific marker called PD-L1. The study is testing combinations of three different drugs: Retifanlimab, INCAGN02385, and INCAGN02390. Researchers want to find out if these combinations can help stop the cancer from getting worse for a longer period of time. They will also look at how many people respond to the treatment, how long that response lasts, and what side effects might occur. This is an early stage study, exploring whether these new treatments are safe and show promise before larger studies are done.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Incyte Biosciences International S.a.r.l.

Enrolment target

Start

22 Oct 2024

In participants with PD-L1–positive and systemic therapy–naive R/M SCCHN.

What is this study about?

This study is a Phase 2 clinical trial focused on head and neck cancer. Specifically, it's for people whose squamous cell carcinoma of the head and neck has either returned or spread, and who haven't had previous treatment for this advanced stage. A key part of who can join is if their cancer has a specific marker called PD-L1. This marker helps researchers understand if certain treatments might work.

The main goal of the study is to see if new combinations of medicines – Retifanlimab, INCAGN02385, and INCAGN02390 – can stop the cancer from growing or spreading for a longer time. This is measured by something called "progression-free survival." They will also be carefully checking how many people see their cancer shrink or disappear (this is called objective response), how long that improvement lasts, and if the treatment causes side effects.

Studies like this are very important because they help us find new and better ways to treat cancer. While these treatments are still experimental, they offer the chance to try cutting-edge therapies that are not yet widely available. The information gathered from this study will help doctors decide if these new drug combinations should be tested in even larger studies, potentially leading to new standard treatments in the future.

Key takeaways

This study evaluates new drug combinations for advanced head and neck cancer.
It targets cancers with a specific marker called PD-L1.
The main goal is to see if treatments can stop cancer growth for longer.
Participation involves regular clinic visits, tests, and closely monitored treatments.
It's a Phase 2 study, meaning the treatments are still experimental.
Your decision to join is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 18 and over, both men and women, who have a specific type of head and neck cancer.

The cancer must be squamous cell carcinoma of the head and neck, and it needs to have either come back or spread to other parts of the body. Also, it's important that you haven't received other treatments for this advanced stage of cancer yet.

Crucially, your cancer cells must show a specific marker called PD-L1 (with a score of CPS ≥ 1). Your doctor will be able to do tests to confirm if your cancer meets this specific requirement, along with other health checks to make sure the study treatments are suitable and safe for you.

Quick self-check

Are you 18 years old or older?
Do you have recurrent or metastatic (spread) squamous cell carcinoma of the head and neck?
Has your cancer been tested and found to be 'PD-L1 positive' (CPS ≥ 1)?
Have you not received any prior treatment for your current advanced head and neck cancer?
Are you generally well enough to participate in a clinical trial?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive one of the experimental drug combinations being tested. These drugs are given as an infusion into your vein.

Throughout the study, you would have regular appointments for check-ups, which include physical exams, blood tests, and scans (like CT or MRI). These tests help the doctors monitor your health, see how the treatment is affecting your cancer, and check for any side effects. You might also have ECGs (heart tests) and your vital signs (like blood pressure) taken regularly.

The research staff will closely monitor you. If you experience any side effects, the doctors might adjust the dose of the medication, pause your treatment, or even stop it if necessary. The total length of your participation would depend on how your cancer responds to the treatment and your overall health, but it involves ongoing visits for treatment and monitoring until certain study goals are met or if your treatment needs to be stopped.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as accessing new treatments that are not yet widely available. For some people, these treatments might help control their cancer or improve their quality of life. However, there are also potential risks, as the treatments are experimental and could cause side effects that are not yet fully known or understood. These side effects could be mild or severe. Before joining, you will be given more detailed information about all known risks. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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Italy
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Greece
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Portugal
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France
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Spain

Common questions

What is squamous cell carcinoma of the head and neck?

It's a type of cancer that starts in the flat, scale-like cells that line the moist surfaces inside the head and neck, such as the mouth, throat, or voice box.

What does 'PD-L1 positive' mean?

PD-L1 is a protein found on some cancer cells. If your cancer is 'PD-L1 positive,' it means the cancer cells have this protein, which can sometimes help doctors choose specific treatments.

What is a Phase 2 study?

A Phase 2 study is an early stage of clinical research. It mainly focuses on seeing if a new treatment is safe and if it shows promise in treating the disease, before being tested in larger groups of people.

What are the new drugs being tested?

The study is testing combinations of three investigational drugs: Retifanlimab, INCAGN02385, and INCAGN02390. These work in different ways to try and fight the cancer.

What is 'progression-free survival'?

This is a measure of how long a person lives with the disease without it getting worse or spreading. It's one way researchers evaluate if a treatment is working.