Active not recruitingPHASE2INTERVENTIONAL

A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma

This research study is investigating a new medication, INCB099280, for individuals who have advanced cutaneous squamous cell carcinoma, which is a type of skin cancer. The main goals are to understand if the new medicine is safe for patients, how well their bodies cope with it, and to see if it shows any early signs of effectively treating the cancer. Participants will receive this new drug, and doctors will carefully monitor their health and the cancer's response. This is a Phase 2 study, meaning it's a more advanced stage of testing, following earlier studies that would have confirmed the medication’s basic safety. The findings from this study will help determine if INCB099280 could be a helpful treatment option in the future.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Incyte Corporation

Enrolment target

Start

09 Oct 2023

Estimated completion

28 Sep 2026

Cutaneous Squamous Cell Carcinoma

What is this study about?

This research study is looking into a new treatment called INCB099280 for a specific type of skin cancer known as cutaneous squamous cell carcinoma. This cancer affects the outer layer of the skin. The study focuses on people whose cancer has spread or is advanced and cannot be completely removed by surgery or treated by radiotherapy alone. The main aim is to understand if this new medicine is safe for patients, how well their bodies can handle it, and if it shows early signs of shrinking the cancer or stopping it from growing.

Finding new ways to treat advanced cancers is very important. While there are existing treatments, researchers are always looking for better and more effective options that might have fewer side effects or work for more people. This particular study is a 'Phase 2' trial, which means it builds on previous early research that showed the drug might be safe and could potentially work.

By taking part, individuals contribute to medical knowledge and help us learn more about potential new treatments for cutaneous squamous cell carcinoma. The information gathered from this study will help doctors decide if INCB099280 should be tested in larger studies and eventually, if it could become a standard treatment available to patients.

Key takeaways

This study is testing a new drug for advanced skin cancer.
It aims to check if the drug is safe and if it helps treat the cancer.
Participation involves taking the new drug and having regular check-ups.
It's for people whose skin cancer is advanced and can't be removed by surgery or radiation.
You have the right to stop participating at any point.

Who may be eligible?

To join this study, you would need to have a confirmed diagnosis of cutaneous squamous cell carcinoma that is considered advanced. This means your cancer might have spread to other parts of your body, or it's a type that can't be cured by standard surgery or radiation treatments. Your general health also needs to be good enough to take part, and doctors will check this with various tests.

There are also some reasons why you might not be able to join. For example, if you have other types of cancer, or if your cancer has spread to your brain in a way that needs treatment. Certain past treatments, like specific types of immunotherapy, would also mean you couldn't join. You might also be excluded if you have certain heart or lung conditions, or active infections, or have had an organ transplant. The study also has rules about recent vaccinations and other medications you might be taking.

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.

Do I have advanced cutaneous squamous cell carcinoma that can't be treated by surgery/radiation alone?
Am I at least 18 years old?
Do I have a good general health status?
Have I not had certain other cancers or specific types of immunotherapy?
Am I willing to avoid pregnancy or fathering children during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new medicine called INCB099280. You'll have regular visits to the clinic where the doctors and nurses will closely monitor your health. These visits will include various assessments like physical exams, blood tests, and scans to see how your body is reacting to the medicine and if the cancer is responding. The doctors will also check for any side effects.

You'll be asked to follow specific instructions regarding contraception to prevent pregnancy, as the effects of the study drug on unborn babies are not fully known. You will be in the study for a certain period, and after you stop taking the medicine, you'll have follow-up appointments to continue monitoring your health for some time. The total duration of your involvement will depend on how you respond to the treatment and the study's design.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and potential risks. You might benefit from the new medicine INCB099280 if it helps to control or shrink your cancer, and you will receive close medical monitoring. However, as this is a new treatment, there is a chance it might not help your cancer, or it could cause side effects that are currently unknown or more serious than expected. Your doctors and the study team will explain all known and potential risks before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (77)

Border Medical Oncology Research Unit
Verified postcode
Albury, Australia
Townsville Cancer Centre
Verified postcode
Townsville, Australia
Princess Alexandra Hospital Australia
Verified postcode
Woolloongabba, Australia
Box Hill Hospital
Verified postcode
Box Hill, Australia
Monash Medical Centre Clayton
Verified postcode
Clayton, Australia
Fundacao Pio Xii Hospital de Cancer de Barretos
Verified postcode
Barretos, Brazil
Cepen - Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina
Verified postcode
Florianópolis, Brazil
Oncosite - Centro de Pesquisa Clinica E Oncologia
Verified postcode
Ijuí, Brazil
Fundacao Doutor Amaral Carvalho
Verified postcode
Jaú, Brazil
Hospital Sao Vicente de Paulo
Verified postcode
Passo Fundo, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Verified postcode
Porto Alegre, Brazil
Hgb - Hospital Giovanni Battista - Mae de Deus Center
Verified postcode
Porto Alegre, Brazil

Common questions

What is cutaneous squamous cell carcinoma?

It's a type of skin cancer that starts in the outer layer of your skin. It can sometimes spread if not treated early.

What does 'advanced' mean in this study?

It means the cancer has spread to other parts of your body or is in a stage where it cannot be cured by surgery or radiation alone.

What is INCB099280?

It's the name of the new medicine being tested in this study. Researchers want to see if it's a safe and effective way to treat advanced skin cancer.

What does a 'Phase 2' study mean?

It means this is a more advanced stage of testing for the medicine, after earlier studies have shown it's likely safe for people to take.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without having to give a reason, and it won't affect your medical care.