Ongoing Clinical Trials for Anaplastic Thyroid Cancer
Two clinical trials are currently ongoing for anaplastic thyroid cancer, exploring innovative treatment approaches including targeted therapies and immunotherapy combinations. These studies are being conducted in France and the Netherlands, offering potential new treatment options for patients with this aggressive form of thyroid cancer.
Clinical trial locations
- France
- Netherlands
Study on the Safety and Effectiveness of Domvanalimab and Zimberelimab for Adults with Advanced Rare Cancers Resistant to Standard Treatment
This trial is testing a combination of two immunotherapy medications called Domvanalimab (also known as AB154) and Zimberelimab (also known as AB122) for patients with advanced forms of five rare cancers, including anaplastic thyroid carcinoma. The study focuses on patients whose cancer has continued to grow or has become resistant to at least one standard treatment.
Main inclusion criteria: Patients must be at least 18 years old with one of the five rare cancers specified in the study, including anaplastic thyroid carcinoma. The cancer must be advanced or metastatic, meaning it has spread to other parts of the body, and must have progressed after at least one previous standard treatment. Patients need to have a life expectancy of at least 16 weeks and be able to perform daily activities (ECOG performance status of 0 or 1). They must have adequate bone marrow, kidney, and liver function, and be willing to provide a tumor tissue sample. Patients must also agree to use effective contraception if of childbearing age and be affiliated with the French social security system.
Main exclusion criteria: Patients who do not have one of the specified rare cancers, including anaplastic thyroid carcinoma, cannot participate. Those whose cancer is not advanced or metastatic, or has not progressed after standard treatment, are not eligible. The study does not accept participants under 18 years old or those who are part of vulnerable populations such as pregnant women or people unable to make decisions for themselves.
Focus of the trial: The study aims to evaluate how well the combination of Domvanalimab and Zimberelimab works in treating patients with rare cancers that have not responded well to other treatments. Both medications are given through intravenous infusion directly into a vein. The treatment period lasts up to 24 weeks, during which researchers will monitor how effective the combination is and assess safety. The goal is to determine if this immunotherapy combination can provide a new treatment option for patients with these challenging conditions.
Investigational drugs: Domvanalimab is an antibody medication that helps the immune system recognize and attack cancer cells by blocking specific proteins that allow cancer cells to hide from the immune system. Zimberelimab is another antibody medication that boosts the immune response against cancer cells by targeting and blocking a protein that helps cancer cells evade the immune system. Together, these medications work to enhance the body’s natural ability to fight cancer.
Study of dabrafenib and trametinib combination therapy before and after surgery in patients with BRAF-mutated anaplastic thyroid cancer
This study focuses specifically on anaplastic thyroid cancer and tests a combination of two targeted therapy medications: dabrafenib and trametinib. These medications are designed for patients whose tumor has a specific genetic change called a BRAF mutation. The treatment is given both before and after surgery to help shrink the tumor and prevent the cancer from returning.
Main inclusion criteria: Patients must be over 18 years old and provide informed consent to participate. They must have confirmed thyroid cancer with a specific genetic mutation called BRAFV600E/K in the tumor tissue. The cancer must not have spread to distant parts of the body. Patients need to have good physical function (WHO Performance Status 0 or 1), meaning they are able to perform daily activities. They must not have received any previous cancer treatments, including chemotherapy, immunotherapy, radiation therapy, or other systemic treatments. Patients must be able to swallow pills, have clear or protected airways, and have acceptable blood test results including blood cell counts, liver function, kidney function, and blood clotting tests.
Main exclusion criteria: Patients who have previously been treated with BRAF or MEK inhibitors or received any cancer treatments within the last 14 days cannot participate. Those with other types of cancer besides anaplastic thyroid cancer, severe heart conditions, or severe liver problems are not eligible. Pregnant or breastfeeding women, patients unable to swallow oral medications, or those with known allergies to the study medications cannot join. Participation in another clinical trial within 30 days before this study also excludes patients, as do any medical or mental health conditions that could interfere with the study treatment or prevent understanding of study requirements.
Focus of the trial: The purpose of this research is to determine if giving these medications before surgery can help more patients have successful tumor removal. Patients take both medications by mouth daily, with dabrafenib at a dose of up to 300 mg per day and trametinib at a dose of up to 2 mg per day. The treatment period may last up to 12 months. After surgery, patients continue taking the medications to help prevent the cancer from returning. Throughout the treatment, doctors monitor patients’ health and how well the medications are working.
Investigational drugs: Dabrafenib is a BRAF inhibitor medication that blocks a specific abnormal protein (BRAF) in some thyroid cancers, helping to slow down or stop cancer cell growth. Trametinib is a MEK inhibitor that works together with dabrafenib by blocking a different protein in the same pathway that helps cancer cells grow. When used together, these medications can make the treatment more effective and help prevent resistance to therapy.
Summary
Currently, two clinical trials are exploring different treatment approaches for anaplastic thyroid cancer. The trials are taking place in two European countries: France and the Netherlands. One study focuses on immunotherapy using a combination of Domvanalimab and Zimberelimab for patients with advanced disease that has resisted standard treatments. This trial includes patients with several rare cancers, including anaplastic thyroid carcinoma. The other study specifically targets patients with BRAF-mutated anaplastic thyroid cancer, testing a combination of dabrafenib and trametinib given both before and after surgery.
These trials represent different therapeutic approaches: immunotherapy that helps the body’s immune system fight cancer, and targeted therapy that specifically blocks proteins involved in cancer cell growth. The availability of these studies in different countries provides potential options for patients with this aggressive form of thyroid cancer, which often has limited treatment choices. Patients interested in participating should discuss eligibility criteria with their healthcare providers to determine which trial might be appropriate for their specific situation.
