Ongoing Clinical Trials for Skin Cancer
Currently, there are 6 clinical trials investigating new treatments for skin cancer. These studies are taking place across multiple European countries and are testing various investigational therapies, including immunotherapies, electrochemotherapy, and targeted treatments. The trials focus on different types of skin cancer, from common forms like basal cell carcinoma and squamous cell carcinoma to rarer types such as Merkel cell carcinoma and uveal melanoma. Participants in these studies may receive treatments such as Balstilimab, DYP688, L19IL2, L19TNF, JK08, Atezolizumab, or Bleomycin-based electrochemotherapy. These trials aim to evaluate the safety, effectiveness, and optimal dosing of these investigational treatments for patients whose cancer cannot be treated with standard therapies or has progressed after previous treatment.
Clinical trial locations
- Belgium
- Czechia
- Denmark
- France
- Study of DYP688 for Patients with Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas
- Study of L19IL2 and L19TNF for Patients with Skin Cancer Suitable for Direct Tumor Injection
- Study on Atezolizumab and Drug Combinations for Advanced Malignancies in Patients from Previous Atezolizumab Trials
- Germany
- Greece
- Hungary
- Italy
- Latvia
- Netherlands
- Poland
- Romania
- Slovakia
- Spain
- Study of DYP688 for Patients with Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas
- Study of L19IL2 and L19TNF for Patients with Skin Cancer Suitable for Direct Tumor Injection
- Study of JK08, Pembrolizumab, and Lenvatinib for Patients with Advanced or Metastatic Cancer
- Study on Atezolizumab and Drug Combinations for Advanced Malignancies in Patients from Previous Atezolizumab Trials
Study on Reducing Bleomycin Dose in Electrochemotherapy for Patients with Skin Cancer
This trial, known as the BLESS Trial, is investigating electrochemotherapy for patients with cutaneous malignancies. The study is examining whether a reduced dose of the medication bleomycin can still effectively shrink or control tumors when combined with electrical pulses.
Main inclusion criteria: Participants must be over 18 years old and able to understand and sign an informed consent document. They must have a type of cancer affecting the skin or tissue just beneath it, confirmed by biopsy, and have a life expectancy of more than three months. Normal kidney function is required, with creatinine levels within normal limits or creatinine clearance greater than 50 ml/min. Participants can receive other treatments like hormone therapy, chemotherapy, or immunotherapy during the study. Previous electrochemotherapy is allowed if at least three months have passed since the last treatment.
Main exclusion criteria: Patients with any cancer that involves the skin cannot participate in this study.
Focus and goals: The trial aims to determine if using half the standard dose of bleomycin in electrochemotherapy can maintain effectiveness while potentially reducing side effects. The primary endpoint is assessing the overall response rate after three months. Secondary assessments include aesthetic outcomes, remission rates, quality of life, side effects monitoring, and pharmacokinetic analysis of bleomycin concentration in blood and tumors.
Investigational drug: Bleomycin is administered intravenously as part of electrochemotherapy. The study explores whether the dosage can be reduced by half while maintaining its effectiveness in treating tumors. Bleomycin works at the molecular level by binding to DNA and causing breaks in DNA strands, leading to cancer cell death.
Study of DYP688 for Patients with Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas
This clinical trial is studying DYP688 for patients with metastatic uveal melanoma, a form of eye cancer that has spread, as well as other melanomas with specific genetic changes known as GNAQ/11 mutations.
Main inclusion criteria: Patients must be at least 18 years old (or 12 years or older in Phase II, depending on location) and weigh at least 40 kg. They must have confirmed metastatic uveal melanoma or advanced skin or mucosal melanoma with GNAQ/11 mutation. The cancer must have progressed after standard treatments or there must be no satisfactory alternative treatments. Patients need adequate performance status and must be willing to undergo necessary biopsies if safe to do so.
Main exclusion criteria: Patients with other types of cancer unrelated to metastatic uveal melanoma or GNAQ/11 mutant melanomas are excluded. Those who have not recovered from previous cancer treatments, have serious heart problems, uncontrolled infections, are pregnant or breastfeeding, or cannot follow study procedures are also excluded.
Focus and goals: The study is divided into two phases. Phase I focuses on determining the best dose of DYP688 and monitoring for side effects and tolerability. Phase II evaluates the medication’s effectiveness in reducing tumor size and slowing disease progression. The trial also assesses duration of response, progression-free survival, overall survival, and development of anti-DYP688 antibodies.
Investigational drug: DYP688 is administered orally and is being studied for its effectiveness against metastatic uveal melanoma and other GNAQ/11 mutant melanomas. It works by interfering with specific pathways crucial for cancer cell survival and proliferation. The medication is classified as an anti-cancer agent.
Study of L19IL2 and L19TNF for Patients with Skin Cancer Suitable for Direct Tumor Injection
This trial is evaluating two treatments, Darleukin (L19IL2) and Fibromun (L19TNF), administered directly into tumors for various types of skin cancers including basal cell carcinoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, keratoacanthoma, malignant adnexal tumors, cutaneous T-cell lymphoma, and Kaposi’s sarcoma.
Main inclusion criteria: Patients must be 18 years or older with at least one skin tumor suitable for direct injection, confirmed by biopsy. They need positive evaluation from an interdisciplinary tumor board indicating potential treatment benefit. Patients must have measurable disease with at least one tumor 10 mm or larger, good general health (ECOG Performance Status 1 or less), life expectancy of at least 12 weeks, and adequate blood counts and organ function. They must agree to undergo multiple biopsies during the study.
Main exclusion criteria: Patients whose cancer cannot be treated with direct tumor injection, those not in situations where treatment aims to cure, prepare for surgery, or relieve symptoms, patients not diagnosed with one of the specified skin cancer types, those outside the study age range, and vulnerable populations are excluded.
Focus and goals: The trial aims to evaluate the efficacy of L19IL2 and L19TNF treatments by measuring the best overall response rate, including complete and partial responses. Secondary evaluations include disease control rate, local progression-free survival, progression-free survival, and safety monitoring. Treatment is administered over up to four weeks with regular monitoring of tumor response.
Investigational drugs: L19IL2 is designed to target and stimulate the immune system to attack cancer cells directly at the tumor site. L19TNF works alongside L19IL2 to target cancer cells and help destroy them by promoting inflammation at the tumor site. Both are administered as intratumoral injections and are classified as immunotherapy agents.
Study of JK08, Pembrolizumab, and Lenvatinib for Patients with Advanced or Metastatic Cancer
This clinical trial is testing JK08, an IL-15 antibody fusion protein targeting CTLA-4, both alone and in combination with Keytruda (pembrolizumab) and Lenvima (lenvatinib) for patients with unresectable locally advanced or metastatic cancer, including various advanced cancers such as melanoma.
Main inclusion criteria: Patients must be at least 18 years old and have unresectable locally advanced or metastatic cancer confirmed by diagnosis. They must have tried standard treatments without success or cannot have them for medical reasons. Performance status must be 0 or 1, with life expectancy of at least 12 weeks. Patients need measurable disease, acceptable lab test results including adequate hemoglobin, platelet count, liver and kidney function. They must agree to fresh tumor biopsies and use effective birth control during the study.
Main exclusion criteria: The trial excludes patients with certain types of cancer outside the study scope, those with untreated brain metastases causing symptoms, and patients unable to follow study procedures.
Focus and goals: The study aims to determine the safety and tolerability of JK08 and establish the best dose for patients. Phase 1 focuses on dose-finding and monitoring side effects. Phase 2 evaluates anti-tumor activity and effectiveness when used as a single agent or in combination. The trial monitors dose-limiting toxicities, adverse events, overall response rate, duration of response, progression-free survival, and overall survival.
Investigational drug: JK08 is administered as a subcutaneous injection, typically weekly. It is an IL-15 antibody fusion protein that targets CTLA-4, a protein involved in regulating the immune system, potentially enhancing the body’s ability to fight cancer cells. It is classified as an immunotherapy agent.
Study on Atezolizumab and Drug Combinations for Advanced Malignancies in Patients from Previous Atezolizumab Trials
This extension trial provides continued treatment with atezolizumab-based therapy or comparator agents for patients who participated in earlier studies and still require ongoing therapy but cannot access these medicines locally.
Main inclusion criteria: Patients must have signed the extension study informed consent form and be eligible to continue receiving atezolizumab-based therapy or comparator agents from their parent study. They must not have local access to the study treatment. The first dose in this extension must be received within 7 days of the treatment interruption window allowed by the parent study. Patients must still be benefiting from the treatment as determined by the study doctor and be able to follow study requirements. Women of childbearing potential must have a negative pregnancy test within 7 days before starting treatment.
Main exclusion criteria: Patients with different types of cancer than those being studied, not currently receiving the specific treatment being studied, having local access to the study treatment, outside the specified age range, unable to follow study procedures, with medical conditions making participation unsafe, or who are pregnant or breastfeeding are excluded.
Focus and goals: The trial aims to provide continued atezolizumab-based therapy or comparator treatments to patients who continue to benefit from them. Regular monitoring and assessment by investigators determine whether treatment continuation is appropriate based on clinical benefit. The study tracks patient responses over the long term.
Investigational drug: Atezolizumab is administered as an intravenous infusion in a clinical setting. It is an immune checkpoint inhibitor that works by blocking the interaction between PD-L1 on cancer cells and PD-1 on immune cells, allowing the immune system to better attack cancer. The trial may also involve comparator agents such as sunitinib, alectinib, cobimetinib, vemurafenib, paclitaxel, venetoclax, and cabozantinib.
Study on Balstilimab for Patients with Advanced Non-Melanoma Skin Cancers
This clinical trial is investigating Balstilimab as a single agent for patients with advanced non-melanoma skin cancers that have spread or cannot be treated with local therapies like surgery or radiation. The study includes various types such as basal cell carcinoma, squamous cell carcinoma, Merkel cell carcinoma, Kaposi sarcoma, and angiosarcoma.
Main inclusion criteria: Patients must be over 18 years old and provide signed informed consent. They must have confirmed non-melanoma skin cancer (except cutaneous lymphomas) that has spread or recurred locally, with at least one measurable or targetable lesion. Patients must be unable to undergo surgery, radiotherapy, or other local treatments, or have progressed on systemic treatment. Adequate blood and organ function is required, including appropriate white blood cell count, hemoglobin levels, platelet count, liver and kidney function. Patients must be able to provide a fresh tumor biopsy, have ECOG Performance Status of 0-2, and estimated life expectancy greater than 12 weeks. Effective contraception is required for those at risk of pregnancy.
Main exclusion criteria: Patients whose cancer can be treated with local therapy, those who have not tried at least one systemic therapy for advanced basal cell carcinoma, patients unable to understand or follow study procedures, and those with medical conditions making participation unsafe are excluded.
Focus and goals: The trial aims to determine if Balstilimab can activate the immune system to provide clinical benefits for patients with advanced non-melanoma skin cancers. The study monitors how well the cancer responds to treatment, duration of positive effects, overall survival rates at 12 and 24 months, side effects, quality of life, and general health changes. Regular assessments include physical examinations, blood tests, imaging studies, and patient-reported outcomes.
Investigational drug: Balstilimab is administered as an intravenous infusion. It is an immunotherapy drug that helps the immune system recognize and attack cancer cells more effectively by activating immune cells. The trial studies its potential for treating advanced or metastatic non-melanoma skin cancers that cannot be treated with local therapies.
Summary
These six clinical trials represent diverse approaches to treating various forms of skin cancer across multiple European countries. The trials are notably concentrated in countries such as France, Spain, and Germany, with Poland being the sole location for the Balstilimab study and Denmark exclusively hosting the bleomycin electrochemotherapy trial.
The investigational treatments span several therapeutic approaches. Immunotherapy features prominently, with studies testing Balstilimab, DYP688, L19IL2, L19TNF, JK08, and Atezolizumab, all designed to enhance the body’s immune response against cancer cells. The BLESS Trial takes a different approach by examining electrochemotherapy using bleomycin with electrical pulses.
The trials address both common and rare forms of the disease. Several studies focus on frequently occurring types like basal cell carcinoma and squamous cell carcinoma, while others target less common forms such as Merkel cell carcinoma, uveal melanoma, Kaposi sarcoma, and cutaneous T-cell lymphoma. Most trials are open to patients whose cancer has progressed after standard treatments or cannot be treated with conventional approaches like surgery or radiation.
These studies aim to provide valuable information about new treatment options, their safety profiles, and their effectiveness in managing various forms of skin cancer. The results may lead to improved therapeutic choices for patients who currently have limited treatment options.
