Ongoing Clinical Trials for Squamous Cell Carcinoma
There are currently 6 ongoing clinical trials investigating new treatments for squamous cell carcinoma across multiple locations in Europe. These trials are testing various combinations of immunotherapy and chemotherapy drugs, including pembrolizumab, cemiplimab, balstilimab, and ALX148, to improve outcomes for patients with advanced forms of the disease.
Clinical trial locations
- Belgium
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Spain
- Study of ALX148 and Pembrolizumab for Patients with Advanced Head and Neck Cancer
- Study of ALX148, Pembrolizumab, and Chemotherapy for Patients with Advanced Head and Neck Cancer
- Study of Pembrolizumab as Additional Treatment for Patients with High-Risk Locally Advanced Cutaneous Squamous Cell Carcinoma After Surgery and Radiation
Study of ALX148 and Pembrolizumab for Patients with Advanced Head and Neck Cancer
This trial is testing a combination of two treatments for patients with advanced head and neck squamous cell carcinoma that has spread or cannot be removed by surgery. The study uses ALX148, a new investigational drug, together with pembrolizumab, a well-established immunotherapy medication also known as Keytruda. Both medications are given through an intravenous infusion.
The main focus of the trial is to see how well this combination works in improving survival rates and how the cancer responds to treatment. The study will last up to 24 months and will closely monitor participants for treatment effectiveness and any side effects that may occur.
Inclusion criteria: Patients must have head and neck squamous cell carcinoma that is PD-L1 positive, meaning the cancer has a specific protein that can be detected. The cancer must have spread or cannot be removed by surgery. Patients should not have received any previous treatment for their advanced cancer, though earlier-stage treatment completed more than 6 months ago is allowed. Participants must be at least 18 years old, have good general health, and have adequate bone marrow, kidney, and liver function. At least one measurable tumor must be present, and a biopsy sample must be available for testing.
Exclusion criteria: Patients who have already received treatment for their advanced disease are excluded. Those with a Combined Positive Score (CPS) less than 1 or whose cancer is not metastatic, unresectable, or recurrent are not eligible.
Study of ALX148, Pembrolizumab, and Chemotherapy for Patients with Advanced Head and Neck Cancer
This trial is similar to the previous one but adds chemotherapy drugs to the treatment combination. Patients will receive ALX148 and pembrolizumab along with chemotherapy drugs 5-Fluorouracil (5FU) and either carboplatin or cisplatin. All medications are given through an intravenous line.
The purpose is to evaluate how effective this triple combination is in improving survival and response rates for patients who have not yet received treatment for their advanced cancer. The study will run for up to 24 months.
Inclusion criteria: Similar to the first trial, patients must have metastatic or unresectable, recurrent head and neck squamous cell carcinoma. A test result showing PD-L1 status must be available. Patients should not have received previous treatment for their advanced disease, though earlier treatment completed more than 6 months ago is acceptable. Good general health, adequate organ function, and at least one measurable tumor are required. Patients must be at least 18 years old and able to follow the study procedures.
Exclusion criteria: Patients who have received treatment for their advanced disease, those with medical conditions other than metastatic or unresectable recurrent head and neck squamous cell carcinoma, and vulnerable populations are excluded.
Study of Cemiplimab for Patients with Stage II to IV Cutaneous Squamous Cell Carcinoma
This trial focuses on skin cancer, specifically cutaneous squamous cell carcinoma in stages II to IV. The treatment being tested is cemiplimab, an immunotherapy drug given through an intravenous infusion before surgery.
The study aims to see how well cemiplimab works when used before surgery. Researchers will examine the cancer cells after surgery to determine if there is a complete response, meaning no cancer cells remain. The trial will also monitor how long participants remain cancer-free and track any side effects.
Inclusion criteria: Patients must have stage II to IV cutaneous squamous cell carcinoma, with stage II tumors measuring at least 3 cm in the longest dimension. At least one measurable tumor is required. Participants must have an ECOG performance status of 0 or 1, indicating they are fully active or have minor restrictions. Adequate organ, bone marrow, and liver function are necessary. Both men and women who are adults can participate.
Exclusion criteria: Patients with other types of cancer, those who have received interfering treatments, individuals with severe allergic reactions to similar drugs, those with uncontrolled medical conditions, pregnant or breastfeeding women, and those unable to follow study procedures are excluded.
Study of Pembrolizumab as Additional Treatment for Patients with High-Risk Locally Advanced Cutaneous Squamous Cell Carcinoma After Surgery and Radiation
This large multi-country trial is investigating pembrolizumab as an additional treatment for patients who have already undergone surgery and radiation therapy for high-risk locally advanced cutaneous squamous cell carcinoma. The study compares pembrolizumab with a placebo to see if it helps prevent the cancer from returning.
Participants will be randomly assigned to receive either pembrolizumab or a placebo through intravenous infusion. The study will monitor how long participants remain cancer-free and assess their overall survival and quality of life.
Inclusion criteria: Patients must have a diagnosis of cutaneous squamous cell carcinoma that has not spread from another cancer type. A tumor tissue sample must be provided for testing. Life expectancy should be more than 3 months, and ECOG performance status must be 0 or 1. The cancer must have been completely removed by surgery, and radiation therapy must have been completed between 4 and 16 weeks before randomization. Patients must be disease-free as determined by imaging tests and cannot be pregnant or breastfeeding.
Exclusion criteria: Patients with other types of cancer, those who have received disallowed previous treatments, individuals with severe allergic reactions to the study medication, those with active infections requiring treatment, pregnant or breastfeeding women, people with autoimmune diseases, those who received live vaccines within 30 days, and individuals with conditions deemed unsafe by study doctors are excluded.
Study on Balstilimab for Patients with Advanced Non-Melanoma Skin Cancers
This trial is testing balstilimab, an investigational immunotherapy drug, for patients with advanced non-melanoma skin cancers, including basal cell carcinoma and squamous cell carcinoma. The medication is given as an infusion into the veins and is being used alone without other treatments.
The purpose is to see if balstilimab can activate the immune system to provide clinical benefits for patients whose cancer has spread or cannot be treated with local therapies like surgery or radiation. The study will monitor how the cancer responds to treatment, how long any benefits last, and track survival rates at 12 and 24 months.
Inclusion criteria: Patients must be over 18 years old with a confirmed diagnosis of any type of non-melanoma skin cancer except cutaneous lymphomas. The cancer must have spread or returned locally with at least one measurable skin or subcutaneous lesion. Surgery, radiotherapy, or other local treatments must not be feasible. Adequate blood and organ function is required, including specific levels of white blood cells, hemoglobin, platelets, and proper liver and kidney function. A fresh tumor biopsy must be provided. ECOG Performance Status must be 0-2, and life expectancy should exceed 12 weeks.
Exclusion criteria: Patients whose cancer can be treated with local therapy are excluded. Those with advanced basal cell carcinoma who have not tried at least one systemic therapy are not eligible. Patients unable to understand or follow study procedures or those with medical conditions deemed unsafe by study doctors are excluded.
Study on Chemotherapy with Cisplatin, Fluorouracil, and Docetaxel for Patients with Locally Advanced Squamous Cell Carcinoma
This trial focuses on locally advanced squamous cell carcinoma occurring in areas such as the mouth, throat, and voice box. The study is investigating a combination of three chemotherapy drugs: cisplatin, 5-fluorouracil (5-FU), and docetaxel. All medications are given through intravenous infusion.
The purpose is to evaluate how effective this chemotherapy combination is in treating the cancer while minimizing side effects. The study will assess treatment success after eight weeks, overall survival, local cancer control, preservation of the voice box, and quality of life.
Inclusion criteria: Patients must have squamous cell carcinoma in the mouth, throat, or voice box confirmed by testing. The tumor must be inoperable or surgery would cause significant harm. No previous treatment for head and neck cancer is allowed. Patients must be between 18 and 75 years old with a WHO performance status of 0 or 1. At least one measurable tumor according to RECIST 1.1 criteria is required. Life expectancy must be at least 3 months, and patients must be able to receive the TPF drug combination.
Exclusion criteria: Patients with other cancer types besides locally advanced squamous cell carcinoma, those with recent different cancer treatments, individuals with severe health conditions that could interfere with treatment, pregnant or breastfeeding women, those unable to follow study procedures or attend regular check-ups, and individuals with known allergies to the study drugs are excluded.
Summary
The six ongoing clinical trials for squamous cell carcinoma represent a range of therapeutic approaches across Europe. A notable concentration of trials exists in Western European countries, particularly Spain, which hosts three different studies, followed by Belgium, Netherlands, Germany, France, and Poland with multiple trials each.
The trials focus on two main types of squamous cell carcinoma: head and neck squamous cell carcinoma and cutaneous (skin) squamous cell carcinoma. Immunotherapy plays a prominent role, with pembrolizumab appearing in four of the six trials, making it the most frequently studied medication. Other immunotherapy drugs being investigated include the newer experimental agents ALX148, cemiplimab, and balstilimab.
Two trials combine immunotherapy with traditional chemotherapy drugs such as cisplatin, carboplatin, 5-fluorouracil, and docetaxel. One trial examines chemotherapy alone without immunotherapy. The trials address different stages of treatment: some test medications before surgery, others after surgery and radiation, and some focus on advanced disease that cannot be treated with surgery.
Most trials require participants to have good general health with adequate organ function and be at least 18 years old. The studies are designed to evaluate whether these treatments can improve survival, prevent cancer from returning, and maintain quality of life for patients living with squamous cell carcinoma.
