Study of INCB099280 for Patients With Advanced Cutaneous Squamous Cell Carcinoma Not Suitable for Surgery or Radiotherapy

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What is this study about?

This clinical trial is focused on studying a type of skin cancer known as advanced cutaneous squamous cell carcinoma (cSCC). The trial is evaluating a new treatment called INCB099280, which is taken as a film-coated tablet. Participants in the study will include those who have not received prior immunotherapy and have either not been treated before or have a recurring form of this cancer that cannot be effectively treated with surgery or radiation.

The purpose of the study is to assess the safety and initial effectiveness of INCB099280 at different doses. Participants will take the medication orally, and the study will monitor their response to the treatment over a period of time. The trial will involve regular check-ups and assessments to ensure the safety and well-being of the participants while gathering data on how the cancer responds to the treatment.

Throughout the study, participants will be closely observed for any side effects or changes in their condition. The trial aims to provide valuable information on whether INCB099280 can be a safe and effective treatment option for those with advanced cSCC. The study is expected to continue until mid-2025, with participants receiving the treatment for a maximum of 24 weeks.

1 joining the study

Upon joining the study, the participant will be required to sign a consent form, indicating their understanding and willingness to participate.

Eligibility is confirmed based on age, diagnosis of advanced cutaneous squamous cell carcinoma (cSCC), and other criteria such as measurable disease and life expectancy.

2 initial assessment

An initial assessment will be conducted, which includes a review of medical history, physical examination, and baseline imaging or photography to document the disease.

A tumor sample may be required for analysis, either from previous procedures or a new biopsy.

3 treatment phase

Participants will receive the study medication, INCB099280, in the form of film-coated tablets.

The medication is administered orally, with dosages of 400 mg, 600 mg, or 800 mg taken twice daily (BID).

The duration of this phase will depend on individual response and tolerance to the medication.

4 monitoring and follow-up

Regular monitoring will occur to assess the safety and effectiveness of the treatment. This includes physical exams, vital signs, ECGs, and laboratory tests.

Participants will be evaluated for any side effects or adverse events, which may lead to adjustments in dosage or discontinuation of the medication.

5 evaluation of response

The response to treatment will be evaluated using imaging or photography to measure changes in the disease.

The primary goal is to determine the objective response, which includes complete or partial reduction of the disease.

6 end of study participation

Participation in the study will conclude based on the study’s timeline or if the participant chooses to withdraw.

Final assessments will be conducted to gather data on the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

Must be able to understand and willing to sign a written consent form for the study.
Must be 18 years or older at the time of signing the consent form.
Must have a confirmed diagnosis of cSCC (cutaneous squamous cell carcinoma). Tumors on the lip are eligible if they started on the skin part of the lip.
Must have cSCC that is either untreated or has come back, and cannot be cured with surgery or radiation, as decided by a doctor.
Must have a disease that can be measured using imaging tests or photographs, with at least one tumor that is 10 mm or larger.
Must have an ECOG performance status of 0 or 1, which means the person is fully active or has some symptoms but can still do light work.
Must have a tumor sample available or be willing to have a biopsy to get a sample for analysis. The sample should be from a recent biopsy or surgery, not older than 1 year (or 6 months for slides).
Must have a life expectancy of more than 3 months, according to the study doctor.
Must agree to avoid pregnancy or fathering children during the study and for a certain period after the last dose of the study drug. Men must take precautions to avoid fathering children and not donate sperm. Women of childbearing potential must have a negative pregnancy test and take precautions to avoid pregnancy, and not donate eggs during the study and for a specified time after.

Who Cannot Join the Study?

Patients who have already received immunotherapy. Immunotherapy is a type of treatment that helps your immune system fight cancer.
Patients who have had surgery or radiotherapy that could cure their cancer. Radiotherapy is a treatment that uses high-energy rays to kill cancer cells.
Patients who have other serious health conditions that might make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or take the study medication as required.
Patients who have allergies to the study medication or its ingredients.
Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Klinički bolnički centar Zagreb (University Hospital Center Zagreb)	Zagreb	Croatia
Centre Hospitalier Universitaire De Lille	Lille	France
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Medisprof S.R.L.	Cluj Napoca	Romania
Hospital Universitario De Navarra	Pamplona	Spain
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Hopital Ambroise Pare	Boulogne-Billancourt	France
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Oncomed S.R.L.	Timisoara	Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Centre Hospitalier Universitaire De Nice	Nice	France
University Of Pecs	Pecs	Hungary
Semmelweis University	Budapest	Hungary
Centre Hospitalier Universitaire Rouen	Rouen	France
Hôpital Avicenne	Bobigny	France
Sigmedical Services S.R.L.	Suceava	Romania
Centre Hospitalier Universitaire De Nantes	Nantes	France
Specijalna Bolnica Medico	Rijeka	Croatia
Netherlands Cancer Institute	Amsterdam	The Netherlands
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Policlinica CCBR S.R.L.	Bucharest	Romania
University Of Szeged	Szeged	Hungary
Centre Hospitalier De Pau	Pau	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
CHU Bordeauxt	Bordeaux	France
Focus Lab Plus S.R.L.	Bucharest	Romania
Cadcce Hlcfbhmhelu Uxinmjqyadsib Db Dftdt	Dijon	France
Agpbzwnfzq Piowovrl Hpahoerh Dm Pudvp	Paris	France
Avfveztnuz Pjgwbwdg Hdhoscmq Dv Mltbnuykz	Marseille	France
Hhjzdozx Ufomfekmsn Cpybhff Hybvqnza	Helsinki	Finland
Hfwfoyjo Dy Ll Sbdbb Cogw I Scfb Pvb	Barcelona	Spain
Iixldpek Ciaeqz Dcppeimevkvhagkij	L'hospitalet De Llobregat	Spain
Hsbjqwiu Uywypwcubajpv Htldbtba Txrgg y Phrirz Iccnwdmq Cvjoeg ddsbucflveoplmwbr (wcsu	Badalona	Spain
Hsgzxdzx Vpoy duunulls	Barcelona	Spain
Iwqjpmra di Cctwdxmiuntc Hhsjbiwzmwm Uhnnmgbyezwez da Skxjg Eotnnbk (xjktiwh	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
Croatia	Not recruiting	03.07.2023
Finland	Not recruiting	03.07.2023
France	Not recruiting	03.07.2023
Hungary	Not recruiting	03.07.2023
Romania	Not recruiting	03.07.2023
Spain	Not recruiting	03.07.2023
The Netherlands	Not yet recruiting	03.07.2023

Trial locations

Investigated drugs:

Incb099280

INCB099280 is an investigational medication being studied for its potential to treat advanced cutaneous squamous cell carcinoma (cSCC). The trial aims to evaluate how safe and tolerable this medication is for patients, as well as its preliminary effectiveness in managing the condition.

Investigated diseases:

Cutaneous Squamous Cell Carcinoma (cSCC) – This is a type of skin cancer that arises from the squamous cells, which are flat cells located in the outer part of the epidermis. It often develops in areas of the skin that have been exposed to the sun, such as the face, ears, neck, and hands. The disease can start as a rough, scaly patch or a sore that does not heal. Over time, it may grow larger and can become invasive, spreading to nearby tissues or other parts of the body. In advanced stages, cSCC may not be suitable for surgical removal or radiation therapy. The progression of cSCC can vary, with some cases remaining localized while others may become more aggressive.

Trial ID:

2022-502476-23-00

Protocol code:

INCB 99280-212

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of INCB099280 for Patients With Advanced Cutaneous Squamous Cell Carcinoma Not Suitable for Surgery or Radiotherapy

What is this study about?

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