Clinical Trials for Metastatic Skin Squamous Cell Carcinoma
There are currently 2 ongoing clinical trials investigating new treatment approaches for metastatic skin squamous cell carcinoma. These studies are testing immunotherapy drugs and targeted therapies for patients whose cancer has spread or cannot be treated with surgery or radiation.
Clinical trial locations
- Austria
- Croatia
- Finland
- France
- Hungary
- Netherlands
- Romania
- Spain
Study of Nivolumab and Nivolumab Plus Relatlimab for Patients with Advanced or Metastatic Skin Squamous Cell Carcinoma
This trial is taking place in Austria and is evaluating two different immunotherapy approaches for treating advanced or metastatic squamous cell carcinoma of the skin. The study compares treatment with Nivolumab alone against a combination of Nivolumab and Relatlimab, both given through intravenous infusion.
Main inclusion criteria: This study is for men and women who are 18 years or older with confirmed locally advanced or metastatic squamous cell carcinoma that cannot be cured. Participants must have tumor samples available for testing specific proteins called PD-L1 and LAG-3, and their disease must be measurable. Patients need to have a life expectancy of at least 12 weeks and a performance status score of 0 to 2, meaning they can still carry out most daily activities. Specific blood test results are required, including adequate levels of white blood cells, platelets, hemoglobin, and normal kidney and liver function. Women who can become pregnant must have a negative pregnancy test and use effective birth control. Any prior radiotherapy must be completed at least 2 weeks before starting the study.
Main exclusion criteria: Patients cannot participate if they have a different type of cancer, have received certain treatments that might interfere with the study, or have other serious health conditions. Pregnant or breastfeeding women are excluded, as are patients who cannot follow study procedures, have allergies to the study medications, are participating in another clinical trial, have had recent major surgery, or have a history of certain infections.
Focus of the trial: The study aims to evaluate how well these immunotherapy treatments work in controlling the cancer, including how long the disease remains stable, how long positive responses last, and overall survival rates. Researchers will also closely monitor the safety and any side effects of the treatments. Treatment can continue for up to five years depending on individual response.
Investigational drugs: Nivolumab is an immune checkpoint inhibitor that blocks the PD-1 protein on immune cells, helping the body’s immune system recognize and attack cancer cells. It is already approved and widely used for various cancers. Relatlimab is another immune checkpoint inhibitor that targets the LAG-3 protein on immune cells. It is being studied in combination with Nivolumab to see if it can enhance the immune response more effectively than Nivolumab alone.
Study of INCB099280 for Patients With Advanced Cutaneous Squamous Cell Carcinoma Not Suitable for Surgery or Radiotherapy
This trial is being conducted across multiple European countries including Romania, Finland, Spain, France, Netherlands, Hungary, and Croatia. It is investigating a new oral medication called INCB099280 in patients with advanced cutaneous squamous cell carcinoma who have not received prior immunotherapy and whose cancer cannot be treated with surgery or radiation.
Main inclusion criteria: Participants must be 18 years or older and willing to sign an informed consent form. They must have a confirmed diagnosis of cutaneous squamous cell carcinoma that is either untreated or has returned and cannot be cured with surgery or radiation. The disease must be measurable, with at least one tumor that is 10 mm or larger. Patients need to have an ECOG performance status of 0 or 1, meaning they are either fully active or have some symptoms but can still do light work. A tumor sample must be available or patients must be willing to undergo a biopsy. Life expectancy must be more than 3 months. Both men and women must agree to use contraception during the study and for a specified period afterward.
Main exclusion criteria: The trial excludes patients who have already received immunotherapy or have had surgery or radiotherapy that could have cured their cancer. Patients with other serious health conditions, those who are pregnant or breastfeeding, those unable to follow study procedures or take the medication as required, patients with allergies to the study medication, and those participating in another clinical trial simultaneously are not eligible.
Focus of the trial: The study aims to assess the safety and tolerability of INCB099280 at different dose levels (400 mg, 600 mg, or 800 mg taken twice daily) and to evaluate its preliminary effectiveness in managing advanced cutaneous squamous cell carcinoma. Participants will be closely monitored through regular check-ups, physical exams, vital signs, ECGs, and laboratory tests. The response to treatment will be evaluated using imaging or photography to measure changes in the disease. The trial is expected to continue until mid-2025, with participants receiving treatment for a maximum of 24 weeks.
Investigational drug: INCB099280 is an oral medication taken as a film-coated tablet twice daily. It is an investigational targeted therapy that is being studied for its potential to inhibit specific molecular pathways involved in cancer cell growth and survival. This drug represents a different treatment approach compared to immunotherapy and is being evaluated in patients who have not previously received immunotherapy for their condition.
Summary
Currently, there are 2 clinical trials available for patients with metastatic or advanced skin squamous cell carcinoma. The trials represent two distinct treatment approaches: immunotherapy and targeted oral therapy.
The first trial, located in Austria, focuses on immunotherapy using Nivolumab either alone or in combination with Relatlimab. This study represents an advancement in immune checkpoint inhibitor therapy, exploring whether combining two different immune checkpoint inhibitors can provide better outcomes than single-agent treatment.
The second trial has a broader geographic reach across seven European countries and investigates INCB099280, an oral targeted therapy. This study is specifically designed for patients who have not received prior immunotherapy, offering an alternative treatment approach for this patient population.
Both trials require that patients have advanced disease not suitable for curative surgery or radiation therapy. The availability of these studies across multiple European countries provides access to investigational treatments for patients with this challenging condition. Patients interested in participating should discuss eligibility with their healthcare providers to determine which trial might be most appropriate for their individual situation.
