Clinical Trials for Basal Cell Carcinoma
This article provides information about 9 ongoing clinical trials investigating various treatments for basal cell carcinoma. These trials are taking place in Denmark, France, Germany, Italy, Poland, and Spain, testing medications including cemiplimab, electrochemotherapy, imiquimod, sonidegib, and other innovative approaches for treating this common form of skin cancer.
Clinical trial locations
- Denmark
- France
- Germany
- Italy
- Poland
- Spain
Evaluation of Cemiplimab Safety and Effectiveness as First Treatment for Advanced Basal Cell Carcinoma in Adult Patients
This trial, conducted in Germany, evaluates cemiplimab as a first-line treatment for patients with advanced disease that cannot be treated with surgery or radiation therapy.
Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis verified by central laboratory testing. They must have locally advanced cancer that cannot be treated with surgery or radiation, or where these treatments are not recommended or refused. Patients need a life expectancy of at least 6 months and good physical performance status. Adequate blood test results, including sufficient white blood cells, red blood cells, platelets, and normal liver and kidney function are required. Women who can become pregnant must have a negative pregnancy test within 7 days before starting the study, and both men and women must use effective birth control during treatment and for 6 months after the last dose.
Main exclusion criteria: The trial excludes patients under 18 years old, those who have received previous treatment with Hedgehog pathway inhibitors, patients currently receiving other cancer treatments, and those with active autoimmune disease. Other exclusions include history of organ transplant, untreated brain or spinal cord metastases, active infections requiring systemic therapy, and known HIV or hepatitis infections. Pregnant or breastfeeding women, patients with serious heart conditions, and those with life expectancy less than 3 months cannot participate.
Treatment focus: The study evaluates cemiplimab given as an infusion at a dose of 350 mg every three weeks for up to 51 weeks. Throughout the treatment period, doctors monitor participants’ response to the medication and check for side effects. The trial tracks various aspects of effectiveness, including how many patients show improvement, how long the treatment works, and patient survival rates.
Investigational drug: Cemiplimab is an immunotherapy medication that helps the immune system fight cancer cells by targeting and blocking a protein called PD-1. This allows the body’s immune cells to better recognize and attack cancer cells. The medication is administered through intravenous infusion.
Study Comparing Electrochemotherapy with Bleomycin to Standard Radiotherapy for Treating Basal Cell Carcinoma in Patients with Tumors Less Than 3 cm
This Danish trial compares two treatment approaches: electrochemotherapy and standard radiotherapy for tumors less than 3 cm in size.
Main inclusion criteria: Participants must be 18 years or older with a biopsy-confirmed diagnosis less than 3 cm in size that can be treated with both radiotherapy and electrochemotherapy. Patients must be able to understand the patient information provided and must have signed informed consent.
Main exclusion criteria: The trial excludes patients with tumors larger than 3 cm, those with other types of skin cancer such as melanoma, and patients not within the specified age range. Those who are part of a vulnerable population or have medical conditions that would make participation unsafe are also excluded.
Treatment focus: The study compares electrochemotherapy, which combines chemotherapy with electrical pulses to enhance drug effects on cancer cells, with standard radiotherapy. Bleomycin is administered as a solution for injection or infusion directly into the tumor. The trial monitors side effects, cosmetic outcomes, and participant satisfaction.
Investigational drugs: Electrochemotherapy combines electricity and chemotherapy to help drugs enter cancer cells more effectively, minimizing damage to surrounding healthy tissue. Standard radiotherapy uses high-energy rays to target and destroy cancer cells.
Study of Cemiplimab Combined with Imiquimod and Laser Therapy Before Surgery for High-Risk Skin Basal Cell Carcinoma
This Spanish trial investigates a combination therapy approach using cemiplimab, imiquimod, and laser therapy as a treatment before surgery for high-risk disease.
Main inclusion criteria: Patients must be at least 18 years old with confirmed high-risk disease that is potentially removable by surgery. The cancer must be considered high risk due to size, location, or type. Participants need adequate organ function and must follow contraception requirements if applicable. A tumor tissue sample must be available before treatment starts. Patients must have an ECOG performance status of 0 or 1 and a life expectancy of at least 24 weeks.
Main exclusion criteria: The trial excludes patients who have had treatment for their skin cancer in the last 6 months, those with metastatic disease or cancer that has spread to lymph nodes, and patients currently participating in another clinical trial. Those with weakened immune systems, pregnant or breastfeeding women, and patients with severe heart, liver, or kidney disease are not eligible.
Treatment focus: The study is conducted in two phases: Phase Ib focuses on safety and side effects, while Phase II examines effectiveness at preventing cancer recurrence after surgery. Participants receive combination treatment before undergoing surgical removal of their tumor. The trial monitors for side effects and tracks whether cancer returns over a three-year period.
Investigational drugs: Cemiplimab is an immunotherapy drug given intravenously that blocks PD-1 protein to help the immune system recognize cancer cells. Imiquimod is a cream applied directly to the skin that stimulates the immune system to fight cancer cells. Fractional laser therapy uses laser light to create tiny wounds in the skin, triggering healing responses and potentially helping other treatments penetrate deeper.
Study on BO-112 for Patients with Resectable Low and High Risk Basal Cell Carcinoma
This Spanish trial tests BO-112, a solution containing polyinosinic:polycytidylic acid, administered directly into tumors.
Main inclusion criteria: Participants must be at least 18 years old with resectable disease, either low or high risk. A diagnostic punch biopsy of all lesions intended for injection is required before the first dose. Patients need adequate organ function, and women of childbearing potential must have a negative pregnancy test and agree to use two effective birth control methods during treatment and for 4 weeks after. Male patients with female partners who can have children must also use two effective birth control methods.
Main exclusion criteria: The trial excludes patients with a different type of cancer, those not within the specified age range, and vulnerable populations. Patients unable to follow study procedures, currently participating in another clinical trial, or who have had certain treatments that might interfere with the study cannot participate. Pregnant or breastfeeding women and those with allergies to the study medication are also excluded.
Treatment focus: The study evaluates the safety, tolerability, and preliminary effectiveness of BO-112 treatment over up to three months. The trial assesses cancer response through visual examination and tissue examination after surgery, tracking side effects and adverse events. Follow-up assessments are conducted at 12 and 24 months after surgery to monitor for recurrence.
Investigational drug: BO-112 is administered through direct injection into the lesion. It works by stimulating the immune system to recognize and attack cancer cells. The medication is classified as an immunotherapy agent.
Study on Tirbanibulin for Treating Superficial Basal Cell Carcinoma in Patients
This French trial evaluates tirbanibulin ointment for treating superficial disease on the trunk or limbs.
Main inclusion criteria: Participants must be over 18 years old with one or more primary, superficial tumors on the trunk or limbs. The longest side should be 15 mm or less. Patients must be affiliated with a Social Security scheme and able to understand study instructions. Signed informed consent is required, which may be provided by a legal representative if necessary.
Main exclusion criteria: The trial excludes patients with any other type of skin cancer besides superficial disease, those who have received treatment within the last 4 weeks, and those with a history of allergic reactions to tirbanibulin. Pregnant or breastfeeding women and patients unable to follow study procedures or attend required visits cannot participate.
Treatment focus: The study monitors treatment effectiveness by checking for complete remission, meaning no evidence of cancer remaining. The trial tracks side effects using a standardized scale and measures tumor thickness using special imaging techniques. Treatment is administered in cycles, with assessments after each cycle to determine the need for further treatment.
Investigational drug: Tirbanibulin is applied directly to the skin and works by stopping the growth of cancer cells. It is classified as a microtubule inhibitor, targeting cellular structures necessary for cancer cell division.
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, conducted in Poland and Germany, tests two medications given as injections directly into tumors for patients not eligible for surgery or radiation.
Main inclusion criteria: Patients must have advanced disease or cutaneous squamous cell carcinoma suitable for intratumoral injection. They should not be eligible for surgery or radiation therapy, or must have refused these treatments. Participants must be between 18 and 100 years old with good general health status (ECOG Performance Status 0 or 1). Required blood test parameters include hemoglobin greater than 10.0 g/dL, platelet count greater than 100 billion per liter, and liver enzymes no more than 1.5 times the normal upper limit. Women who can have children must have a negative pregnancy test and use effective birth control.
Main exclusion criteria: The trial excludes patients with metastatic cancer or cancer that has spread to lymph nodes, those eligible for surgery or radiation therapy, and patients without histological evaluation. Vulnerable populations cannot participate.
Treatment focus: The study involves administering Fibromun and Darleukin directly into tumors for up to four months. The trial evaluates how well these treatments work in shrinking or eliminating tumors by assessing overall response, including complete disappearance and partial reduction in size. Safety monitoring throughout the study tracks side effects and reactions.
Investigational drugs: 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, aiming to reduce tumor size and improve overall response.
Study on Balstilimab for Patients with Advanced Non-Melanoma Skin Cancers
This Polish trial investigates balstilimab for advanced forms of non-melanoma skin cancers that have spread or cannot be treated with local therapies.
Main inclusion criteria: Participants must provide signed informed consent and have adequate blood and organ function, including white blood count greater than 3000/µl, hemoglobin greater than 8 g/dl, and platelet count greater than 100,000/µl. Patients must be over 18 years old with 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 lesion. Patients must have ECOG Performance Status of 0-2 and life expectancy over 12 weeks.
Main exclusion criteria: The trial excludes patients with skin cancer treatable with local therapy and those with advanced disease who have not tried at least one systemic therapy. Patients unable to understand or follow study procedures or with medical conditions making participation unsafe cannot participate.
Treatment focus: The study evaluates whether balstilimab can activate the immune system to provide clinical benefits. Participants receive balstilimab through intravenous infusion and are monitored to assess cancer response, tracking how long positive effects last and monitoring side effects. The trial gathers data on overall survival rates at 12 and 24 months and changes in quality of life.
Investigational drug: Balstilimab helps the body’s immune system fight cancer cells by activating immune cells. It is classified as an immunotherapy drug that helps the immune system recognize and attack cancer cells.
Study on Blood Vessel Changes in Basal Cell Carcinoma Patients Treated with Bleomycin or Drug Combination
This Danish trial studies changes in blood vessels using two non-surgical treatments: electrochemotherapy and photodynamic therapy.
Main inclusion criteria: Patients must be mentally capable of understanding information given and must provide written informed consent. They must have clinically diagnosed low-risk disease on the trunk and extremities, with size less than 2 cm. Participants must be at least 18 years old with cases reviewed by a dermatological specialist. They must be classified as ASA class I-III and have no prior history of sensitivity or allergies to the chosen treatment drug. A punch biopsy must be performed at 1-year follow-up. Women of non-childbearing potential must have had a hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or be post-menopausal. Women of childbearing potential need a negative pregnancy test within 2 weeks before treatment.
Main exclusion criteria: The trial excludes patients with other types of skin cancer besides the condition being studied, those younger than 18 or older than 65 years old, and vulnerable populations. Patients with medical conditions making participation unsafe are also excluded.
Treatment focus: The study observes how treatments affect small blood vessels using optical coherence tomography, a non-invasive imaging method. Changes in blood vessels are monitored at different skin depths before and after treatment. The trial also looks at factors like tumor thickness and density, as well as side effects such as skin darkening, to understand treatment outcomes and impact on quality of life.
Investigational drugs: Electrochemotherapy combines chemotherapy drugs with electrical pulses to help drugs enter cancer cells more effectively. Photodynamic therapy uses a special light with a drug that becomes active when exposed to light, killing cancer cells.
Study on Sonidegib for Patients with Locally Advanced Basal Cell Carcinoma
This Italian trial tests sonidegib, taken as a hard capsule, to see how well patients can follow a tailored treatment plan after responding well to similar previous treatment.
Main inclusion criteria: Participants must provide written signed consent, including permission for photographs of lesions. Women of childbearing potential need a negative pregnancy test within 7 days before treatment and must agree not to breastfeed during the study and for 20 months after the last dose. Male participants must agree to use condoms during sexual intercourse while being treated and for 6 months after, and not donate sperm during this period. All participants must agree not to donate blood for at least 20 months after the last dose. Patients must be at least 18 years old with confirmed locally advanced diagnosis, currently receiving Hedgehog inhibitor treatment. They must have shown complete response within 3 months before screening and have ECOG performance status of 0 to 2 with adequate blood cell levels and organ function.
Main exclusion criteria: The trial excludes patients who have not previously achieved complete response with any Hedgehog pathway inhibitor, those not within the specified age range, and vulnerable populations.
Treatment focus: Participants take sonidegib according to a tailored schedule with specific periods on and off medication. The study lasts up to two years, monitoring how well patients stick to the treatment plan and how their condition responds. Regular check-ups assess health and treatment effectiveness, including imaging of affected skin areas. The primary goal is maintaining tailored treatment for 12 months after enrollment.
Investigational drug: Sonidegib is taken orally and works by blocking the Hedgehog signaling pathway, which is often overactive in certain cancers. It belongs to a class of drugs known as Hedgehog pathway inhibitors, helping to slow down or stop cancer cell growth.
Summary
These nine clinical trials represent diverse approaches to treating different stages and types of disease. The trials are distributed across six European countries, with Spain hosting two trials and Denmark, France, Germany, Italy, and Poland each hosting one or two trials. Germany and Poland participate in a multi-country trial testing L19IL2 and L19TNF.
The trials test various treatment approaches, from immunotherapy drugs like cemiplimab and balstilimab to targeted therapies like sonidegib, and innovative local treatments such as electrochemotherapy and photodynamic therapy. Several trials focus on combination approaches, including cemiplimab with imiquimod and laser therapy, while others evaluate single treatments like tirbanibulin ointment or BO-112 injections.
The studies address different disease stages, from superficial forms treatable with topical medications to locally advanced and metastatic disease requiring systemic therapy. Some trials specifically target patients who are not eligible for surgery or radiation, providing alternative treatment options for this patient population. Several trials also emphasize quality of life assessments and long-term follow-up to understand the full impact of treatments on patients.
