Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma

This research study is investigating a new medication, INCB099280, for individuals diagnosed with advanced cutaneous squamous cell carcinoma (a type of skin cancer). This is specifically for patients whose cancer has not been treated with immunotherapy and cannot be completely removed by surgery or treated by radiation. The main goal is to see how well the new medicine shrinks the cancer. Another important part of the study is to understand its safety, including any side effects. Researchers will closely monitor participants through physical exams, blood tests, and scans. This is a Phase 2 study, meaning it's still in the earlier stages of drug development, looking for promising effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Incyte Corp.

Enrolment target

Start

12 Sep 2023

Treatment of immunotherapy-naive patients with previously untreated or recurrent locally advanced or metastatic cSCC not amenable to curative surgery and/or radiotherapy

What is this study about?

This research study is exploring a new medicine called INCB099280 for people who have a specific type of skin cancer. This cancer is known as advanced cutaneous (meaning skin) squamous cell carcinoma, or cSCC for short. 'Advanced' means the cancer is either locally advanced (it has spread to nearby tissues) or metastatic (it has spread to other parts of the body). This study is for patients whose cancer hasn't been treated with a type of therapy called immunotherapy before, and importantly, whose cancer cannot be cured by surgery or radiotherapy.

The main aim of this study is to see if INCB099280 can make the cancer shrink or disappear, which doctors call an 'objective response'. They will also be carefully watching for any side effects or unwanted reactions to the medicine, which are called 'adverse events'. These are assessed through regular check-ups, blood tests, and other medical evaluations to make sure the medicine is safe. Understanding both how well the medicine works and its safety profile is crucial at this stage of development.

This is what is called a 'Phase 2' study. This means that the medicine has already been tested in a small number of people, and now researchers want to gather more information on its effectiveness and safety in a larger group of patients. The results from this study will help determine if INCB099280 is a promising treatment that should be studied further in even larger trials.

Key takeaways

This study tests a new medicine (INCB099280) for advanced skin cancer (cSCC).
It's for people whose cancer hasn't had immunotherapy and can't be treated with surgery/radiotherapy.
The main goals are to see if the medicine shrinks the cancer and what side effects it has.
This is a Phase 2 study, part of the early testing of new treatments.
Participation involves regular check-ups, tests, and monitoring.

Who may be eligible?

To be eligible for this study, you must be at least 18 years old. Both men and women can take part.

Critically, you must have advanced cutaneous squamous cell carcinoma that hasn't been treated with immunotherapy before. Your doctors must also have determined that your cancer cannot be completely removed by surgery or effectively treated with radiation.

There might be other health conditions or medications that would prevent someone from joining the study, but these are the main points. The research team will review your medical history carefully to see if this study is right for you.

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 18 years old or older?
Do you have advanced cutaneous squamous cell carcinoma?
Have you *not* had immunotherapy for your cancer before?
Has your doctor said your cancer cannot be cured with surgery or radiotherapy?
Are you able to attend regular study appointments and tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the new medicine, INCB099280. You will have regular appointments with the study team, where they will conduct physical examinations, take blood and urine samples, and perform imaging scans (like CT scans) to see how the treatment is affecting your cancer. Your heart rate, blood pressure, and other vital signs will also be monitored closely. The total duration of your participation will depend on how you respond to the treatment and the study's design, and you will be kept informed throughout.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new treatment that could help shrink or stabilize your cancer, especially if other treatments haven't worked or aren't suitable. However, as with any new medicine, there's a risk of side effects, which could range from mild to severe. The study team will closely monitor you for any adverse effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Netherlands
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Unverified
Finland
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Unverified
Romania
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Unverified
France
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Unverified
Hungary
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Unverified
Croatia

Common questions

What is cutaneous squamous cell carcinoma?

It's a common type of skin cancer that starts in the flat cells on the outer layer of the skin. 'Advanced' means it has grown or spread.

What is 'immunotherapy-naive'?

This means you have not had treatment with immunotherapy medicines before for your cancer.

What does a 'Phase 2 study' mean?

It means the medicine has been tested for safety in a small group, and now researchers are looking at how well it works and its safety in a larger group of people with the condition.

What is INCB099280?

It's the name of the new investigational medicine being tested in this study for advanced skin cancer.

Will I still receive my regular care if I join the study?

Yes, you will continue to receive medical care and monitoring from the study team, and you can withdraw at any time without affecting your standard care options.