Ongoing Clinical Trials for Recurrent Skin Squamous Cell Carcinoma
There is currently 1 ongoing clinical trial for recurrent skin squamous cell carcinoma. This trial is investigating a new oral medication called INCB099280 for patients whose cancer cannot be treated with surgery or radiotherapy. The trial is being conducted across multiple European countries and is designed to evaluate the safety and initial effectiveness of this investigational treatment.
Clinical trial locations
- Croatia
- Finland
- France
- Hungary
- Netherlands
- Romania
- Spain
Study of INCB099280 for Patients With Advanced Cutaneous Squamous Cell Carcinoma Not Suitable for Surgery or Radiotherapy
This clinical trial is evaluating a new oral medication called INCB099280 for patients with advanced cutaneous squamous cell carcinoma (cSCC) that has either never been treated or has come back after treatment. The study focuses on patients whose cancer cannot be effectively managed with surgery or radiation therapy.
Main inclusion criteria:
- Patients must be 18 years of age or older
- Must have a confirmed diagnosis of cutaneous squamous cell carcinoma that is either untreated or recurrent
- The cancer must be unsuitable for curative surgery or radiation therapy
- Must have measurable disease with at least one tumor that is 10 mm or larger
- Must have an ECOG performance status of 0 or 1, meaning they are either fully active or able to perform light work despite some symptoms
- Must have a life expectancy of more than 3 months
- Must have a tumor sample available or be willing to undergo a biopsy
- Must agree to use appropriate contraception during the study period
Main exclusion criteria:
- Patients who have previously received immunotherapy
- Patients who have had surgery or radiotherapy that could have cured their cancer
- Patients with other serious health conditions that might make participation unsafe
- Pregnant or breastfeeding women
- Patients unable to follow study procedures or take the medication as required
- Patients with allergies to the study medication or its ingredients
- Patients currently participating in another clinical trial
Focus and goal: The primary goal of this trial is to assess the safety and tolerability of INCB099280 at different doses while also evaluating its preliminary effectiveness in treating advanced cutaneous squamous cell carcinoma. The study involves taking the medication orally as film-coated tablets at doses of 400 mg, 600 mg, or 800 mg twice daily. Participants will undergo regular monitoring through physical examinations, laboratory tests, and imaging or photography to measure how the cancer responds to treatment. The trial will track any side effects and changes in the disease over time, with treatment continuing for up to 24 weeks. The study is expected to run until mid-2025.
Investigational drug: INCB099280 is an experimental medication administered as an oral tablet taken twice daily. It is being studied for its potential to target specific molecular pathways involved in cancer cell growth and survival. This drug represents a targeted cancer therapy approach for patients with advanced cSCC who have not previously received immunotherapy and whose condition cannot be managed with conventional surgical or radiation treatments.
Summary
Currently, there is one active clinical trial available for patients with recurrent skin squamous cell carcinoma. This trial is notably accessible across seven European countries: Croatia, Finland, France, Hungary, Netherlands, Romania, and Spain, providing broad geographical coverage for eligible patients in Europe.
The trial focuses exclusively on the investigational drug INCB099280, which is being studied as a potential treatment option for patients whose cancer has either not been treated before or has returned, and cannot be managed with surgery or radiation. A key requirement is that participants must not have previously received immunotherapy, indicating that this trial is targeting a specific patient population with limited prior treatment exposure.
The study represents an important research effort for patients with advanced disease who have exhausted conventional treatment options. The multi-country approach suggests a coordinated effort to gather robust data on the safety and effectiveness of this new targeted therapy for cutaneous squamous cell carcinoma.
