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Squamous cell carcinoma of skin – Trials in Disease

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Ongoing Clinical Trials for Squamous Cell Carcinoma of Skin

There are currently 6 ongoing clinical trials studying new treatments for squamous cell carcinoma of skin across Europe. These trials are testing various immunotherapy approaches, including checkpoint inhibitors and combination therapies, for patients with different stages of this skin cancer. The trials are being conducted in multiple countries including Germany, Poland, France, Italy, Spain, Belgium, Netherlands, Greece, Ireland, Bulgaria, Hungary, Romania, Czechia, and Norway.

Clinical trial locations

Study of nivolumab and ipilimumab combination therapy as an alternative to surgery and radiation in patients with skin squamous cell carcinoma

This trial is exploring whether immunotherapy can replace traditional surgery and radiation therapy for patients with this type of skin cancer. The study focuses on patients who would normally require extensive surgery due to UV-related skin cancer at stages I to IVa.

Who can participate: Patients must be 18 years or older with confirmed diagnosis affecting specific areas such as the lip, ear, face, scalp, neck, or eyelid. They must be physically capable of performing daily activities with a WHO performance status of 0-2 and have adequate blood test results for white blood cells, platelets, hemoglobin, and kidney and liver function. Women of childbearing potential must use effective birth control for 23 weeks after treatment and have a negative pregnancy test. Men who are sexually active with women of childbearing potential must use contraception for 31 weeks after treatment.

Who cannot participate: The trial excludes patients with cancer that has spread to other parts of the body, those previously treated with immunotherapy, people with active autoimmune diseases, those taking immune-suppressing medications, pregnant or breastfeeding women, patients with serious heart conditions or uncontrolled high blood pressure, organ transplant recipients, those with active infections requiring treatment, patients with other active cancers, people with known allergies to the study medications, and those who have had major surgery within 4 weeks before the study starts.

What the trial involves: The study uses immunotherapy, which helps the immune system recognize and attack cancer cells. Participants will receive two medications through intravenous infusion: Yervoy (ipilimumab) and Opdivo (nivolumab). Regular monitoring includes blood tests to check white blood cell count, platelet levels, hemoglobin, liver function, and kidney function. The response to treatment will be evaluated at 12, 18, and 24 months after treatment. Patients will also complete quality of life questionnaires throughout the study period.

Study on Cemiplimab for Patients with High-Risk Stage III/IV Cutaneous Squamous Cell Carcinoma

This trial investigates whether using cemiplimab, an immunotherapy medication, both before and after surgery can help reduce the risk of cancer returning in patients with high-risk stage III or IV cancer that can be surgically removed.

Who can participate: Patients must be at least 18 years old with surgically removable, high-risk stage III/IV cancer that has not spread to other parts of the body. They must be medically fit for surgery as determined by a surgical team. Patients need measurable disease and good general health with ECOG performance status 0-1. Blood test requirements include specific levels for absolute neutrophil count, hemoglobin, platelets, blood clotting factors, bilirubin, liver enzymes, albumin, and creatinine. Women who can become pregnant must have a negative pregnancy test and use reliable birth control during the study and for 6 months after the last dose of cemiplimab. Men who are sexually active with women of childbearing potential must also use reliable birth control for 6 months after treatment.

Who cannot participate: Patients with any other type of cancer besides this specific skin cancer, those whose cancer cannot be surgically removed, patients with cancer that has spread to distant parts of the body, and those not considered high risk for cancer recurrence are excluded. The study also excludes those not within the specified age range and vulnerable populations unable to give informed consent.

What the trial involves: Cemiplimab is given through intravenous infusion in two phases: before surgery (neoadjuvant treatment) to reduce tumor size, and after surgery (adjuvant treatment) to help prevent cancer recurrence. The surgical procedure aims to achieve a major pathological response, meaning less than 10% of viable tumor cells remain after removal. Regular follow-up visits include physical exams and possibly imaging tests to monitor for signs of cancer recurrence and evaluate overall survival.

Study of L19IL2 and L19TNF for Patients with Advanced Basal Cell Carcinoma or Cutaneous Squamous Cell Carcinoma Not Eligible for Surgery or Radiation

This trial examines two medications, Fibromun and Darleukin, administered directly into the tumor for patients with advanced skin cancer who cannot undergo surgery or radiation therapy. The study evaluates how well these treatments work in shrinking or eliminating tumors.

Who can participate: Patients must have advanced basal cell carcinoma or this type of skin cancer suitable for direct injection into the tumor. They should not be eligible for surgery or radiation therapy, or have refused these treatments. A detailed examination of cancer cells must be available. Patients can have measurable and injectable cancer without lymph node involvement. Age range is 18 to 100 years. Good general health with ECOG Performance Status 0 or 1 is required, along with hemoglobin levels greater than 10.0 g/dL, platelet count greater than 100 billion per liter, liver enzymes no more than 1.5 times the normal upper limit, and serum creatinine less than 1.5 times the normal upper limit. Women of childbearing potential must have a negative pregnancy test and use effective birth control during the study and for three months after treatment. Men with partners who can become pregnant must use two forms of birth control during the study and for three months after treatment.

Who cannot participate: The trial excludes patients with cancer that has spread to other parts of the body or to lymph nodes, those eligible for surgery or radiation therapy, patients without histological evaluation, and those from vulnerable populations who might need special protection or care.

What the trial involves: L19IL2 and L19TNF are administered through intratumoral injection, meaning directly into the tumor. L19IL2 combines a protein that targets cancer cells with a substance that stimulates the immune system. L19TNF targets cancer cells and delivers a substance that can cause their death. Regular monitoring assesses the response to treatment, including measuring tumor size and checking for side effects. Follow-up visits evaluate the overall response rate and ensure treatment safety.

Study of Cemiplimab Alone and with RP1 for Patients with Advanced Skin Squamous Cell Carcinoma

This trial compares the effectiveness of cemiplimab used alone versus cemiplimab combined with RP1 (Vusolimogene oderparepvec) for patients with advanced cancer that has spread locally or to other parts of the body.

Who can participate: Patients must be male or female aged 18 years or older with confirmed diagnosis of locally advanced or metastatic cancer. They need at least one measurable tumor that can be injected, at least 1 cm in size. ECOG performance status should be 0 or 1, though status 2 may be allowed if due to the disease. Liver function tests must show total bilirubin no more than 1.5 times the normal limit (or up to 3 times if liver metastases are present), transaminases no more than 3 times normal (or up to 5 times with liver metastases), and alkaline phosphatase no more than 2.5 times normal (or up to 5 times with liver or bone metastases). Blood tests must show hemoglobin at least 9.0 g/dL, absolute neutrophil count at least 1.5 x 10⁹/L, and platelet count at least 100 x 10⁹/L. Prothrombin time should be no more than 1.5 times normal. Life expectancy must be more than 12 weeks. Patients who can have children must use effective birth control during the study and for 6 months after treatment, and male patients must agree not to donate sperm during this time. For locally advanced cancer, patients must not be suitable for surgery or radiation therapy that could cure the cancer, or have refused such treatments.

Who cannot participate: The trial excludes patients with different types of cancer, those outside the specified age range, vulnerable populations, patients unable to follow study procedures, those with medical conditions that could interfere with the study or make participation unsafe, patients currently in another clinical trial, those who have had recent treatment that might affect results, pregnant or breastfeeding women, and patients with allergies or sensitivity to the study medication.

What the trial involves: Participants are randomly assigned to receive either cemiplimab alone or cemiplimab combined with RP1. Cemiplimab is administered as an intravenous infusion at a dose of 350 mg. RP1 is given through injections directly into the tumor. Cemiplimab works by helping the immune system recognize and attack cancer cells. The study monitors cancer response over time through regular scans and clinical assessments. The treatment phase continues until the study’s end date, estimated to be August 15, 2025, with follow-up visits to monitor long-term effects and overall health.

Study of Cemiplimab Compared to Placebo After Surgery and Radiation for Patients with High-Risk Skin Squamous Cell Carcinoma

This trial compares cemiplimab with a placebo in patients at high risk of cancer recurrence after completing surgery and radiation therapy. The goal is to determine if cemiplimab can help prevent cancer from returning.

Who can participate: Patients must have had surgery to remove confirmed cancer, which can be the main skin cancer lesion, the main lesion with cancer spread to nearby lymph nodes, or cancer spread to lymph nodes with a known main lesion that was previously treated. The cancer must be high-risk. Patients must have completed radiation therapy aimed at curing the cancer within 2 to 10 weeks before being randomly assigned to a treatment group. An Eastern Cooperative Oncology Group performance status of 0 or 1 is required, meaning fully active or restricted in physically strenuous activity but able to carry out light work. Adequate liver, kidney, and bone marrow function as defined in the study protocol is necessary. The study is open to both male and female patients, including those who may be considered vulnerable.

Who cannot participate: Patients who have not had surgery and radiation therapy, those with other types of cancer, patients with serious infections or illnesses that could affect participation, pregnant or breastfeeding women, those unable to follow study procedures or attend follow-up visits, patients who received another experimental treatment within a certain timeframe before the study, those with known allergies to the study medication or its ingredients, patients with a history of certain heart conditions or other serious health issues, those taking medications that could interfere with the study treatment, and patients with a history of drug or alcohol abuse that could affect participation are excluded.

What the trial involves: After completing surgery and radiation therapy, patients are randomly assigned to receive either cemiplimab or a placebo through intravenous infusion. The treatment consists of LIBTAYO 350 mg concentrate for solution for infusion or a matching placebo. Health is monitored regularly through check-ups including blood tests and other necessary examinations. The primary outcome measured is disease-free survival, which is the time from randomization to the first documented recurrence or death from any cause. Secondary outcomes include overall survival, freedom from locoregional and distant recurrence, and the occurrence of new primary tumors. The study is estimated to conclude by March 25, 2029.

Study of mRNA-4157 and Pembrolizumab for Patients with Resectable Locally Advanced Cutaneous Squamous Cell Carcinoma

This trial tests a new treatment approach using a combination of V940 (mRNA-4157), a special treatment using synthetic messenger RNA to help the body recognize and fight cancer cells, and pembrolizumab, a medication that helps the immune system attack cancer cells more effectively. The study compares this combination with standard treatment options.

Who can participate: Participants must have confirmed diagnosis of cancer that can be surgically removed without causing major functional loss or severe disfigurement. A performance status of 0 to 1 is required, meaning fully active or having some symptoms but still able to carry out light work. Adequate organ function is necessary. If participants have Hepatitis B, they must have been on antiviral therapy for at least 4 weeks with no detectable virus in blood before starting. Those with a history of Hepatitis C must have no detectable virus at the start of the study. HIV-infected participants must have well-controlled condition with medication. The cancer must be locally advanced, meaning it has not spread to distant parts of the body, and must be removable by surgery with curative intent. A tumor sample suitable for genetic testing is required. Participants can be of any sex or gender and must be at least 18 years old. Males must avoid pregnancy by abstaining from intercourse or using effective birth control during and after the study. Females must not be pregnant or breastfeeding and must use effective birth control or abstain from intercourse during and after the study. Measurable disease is required, meaning the cancer can be measured by study criteria. Life expectancy must be more than 3 months.

Who cannot participate: Participants cannot have skin cancer that has spread from another primary cancer or from an unknown primary cancer. They must have a confirmed diagnosis of the specific type of cancer studied, which must be surgically removable.

What the trial involves: Initial assessment confirms eligibility, including verifying diagnosis and ensuring adequate organ function. A tumor sample suitable for next-generation sequencing is required, along with other health criteria such as controlled HIV or undetectable hepatitis viral loads if applicable. Participants are randomly assigned to receive the combination of V940 and pembrolizumab, pembrolizumab alone, or standard care treatment. V940 is administered as an intramuscular injection, while pembrolizumab is given as an intravenous infusion. Regular monitoring assesses treatment effectiveness and side effects through physical examinations, imaging studies, and laboratory tests. The primary goal is to evaluate event-free survival, while secondary outcomes include response to treatment and overall survival. The study is expected to conclude by May 2033.

Summary

The six ongoing clinical trials for squamous cell carcinoma of skin demonstrate a strong focus on immunotherapy approaches across multiple European countries. Germany, Poland, France, Italy, and Spain stand out as hubs for this research, each hosting multiple trials. The most widely tested medication is cemiplimab, which appears in four of the six trials, either alone or in combination with other treatments.

The trials address different clinical scenarios: some study treatment before and after surgery for high-risk patients, others explore alternatives to surgery and radiation for advanced cases, and one examines direct tumor injection therapies for patients who cannot undergo traditional treatments. Several trials investigate combination approaches, such as cemiplimab with RP1 or pembrolizumab with mRNA-4157, suggesting that researchers are exploring whether combining different immunotherapy mechanisms might improve outcomes.

Most trials are designed for patients with advanced or high-risk disease, though eligibility criteria vary depending on whether the cancer can be surgically removed and whether it has spread. Common requirements across trials include good general health status, adequate organ function, and willingness to use effective birth control due to potential effects on pregnancy. The trials collectively offer opportunities for patients at different stages of the disease and in various clinical situations, from those who can still have surgery to those for whom traditional treatments are not suitable options.

Ongoing Clinical Trials on Squamous cell carcinoma of skin

  • Study on Cemiplimab for Patients with High-Risk Stage III/IV Cutaneous Squamous Cell Carcinoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study of Nivolumab and Nivolumab Plus Relatlimab for Patients with Advanced or Metastatic Skin Squamous Cell Carcinoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

  • A study of cemiplimab in patients with locally advanced cutaneous squamous cell carcinoma

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of L19IL2 and L19TNF for Patients with Advanced Basal Cell Carcinoma or Cutaneous Squamous Cell Carcinoma Not Eligible for Surgery or Radiation

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Poland

  • Study of Cemiplimab Compared to Placebo After Surgery and Radiation for Patients with High-Risk Skin Squamous Cell Carcinoma

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Greece Ireland Italy +2

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