In short
There is currently 1 ongoing clinical trial for vaginal cancer, testing a combination of immunotherapy treatments for advanced HPV-16 positive cancers. The trial is being conducted in France and Spain.
Clinical trial locations
- France
- Spain
Study of TG4001 and Avelumab for Patients with Advanced HPV-16 Positive Cancers
This trial is testing a combination of two immunotherapy treatments for patients with advanced cancers caused by the HPV-16 virus. The cancers being studied include those affecting the head and neck, cervix, vulva, vagina, penis, and anus. The study aims to understand whether combining two different types of immune system treatments can help fight these cancers more effectively than using one treatment alone.
Main focus: The trial is divided into two main phases. The first phase focuses on evaluating the safety and tolerability of combining TG4001 and avelumab. Researchers want to make sure patients can handle the combination treatment without serious side effects. The second phase compares how well the combination therapy works compared to using avelumab alone, specifically looking at how long patients live without their cancer getting worse.
Investigational drugs: The trial uses two drugs. TG4001 is a therapeutic vaccine given as an injection under the skin. It works by training the immune system to recognize and attack cancer cells linked to the HPV-16 virus. Avelumab is an immunotherapy drug given through an intravenous infusion into the bloodstream. It is a type of checkpoint inhibitor that helps remove barriers that prevent the immune system from attacking cancer cells. By blocking a protein called PD-L1, avelumab allows the immune system to better detect and destroy cancer cells.
Who can participate: The trial is open to adults aged 18 and older with no upper age limit. Patients must have cancer that is positive for HPV-16 and has either come back after treatment or has spread to other parts of the body. The cancer must not be curable by surgery or radiation therapy. Patients should be able to perform light activities and have a life expectancy of at least 3 months. Women who could become pregnant must have a negative pregnancy test, and all patients of childbearing potential must use effective birth control during the study and for 3 months after. Patients may have had up to two previous chemotherapy treatments for advanced or recurrent cancer. Those with cancer that has spread to the liver can participate only if there are no more than 3 liver lesions and the largest is 30 mm or smaller. Patients must have at least one tumor that can be measured by CT scan and must have adequate blood, liver, and kidney function.
Who cannot participate: Patients are excluded if they have liver metastases at the start of the study, meaning cancer has spread to the liver. Those who are not positive for HPV-16 or do not have recurrent or metastatic cancer cannot join. Additionally, patients must have one of the specific cancer types being studied, such as cancers of the oropharynx, cervix, vulva, vagina, penis, or anus.
Summary
Currently, there is one clinical trial available for patients with vaginal cancer, specifically those with advanced HPV-16 positive disease. This trial is being conducted in France and Spain and represents an opportunity for patients whose cancer has spread or returned after previous treatment. The study focuses on testing a combination immunotherapy approach using TG4001, an investigational therapeutic vaccine, together with avelumab, an approved checkpoint inhibitor. This combination aims to harness the immune system's power to fight cancer cells more effectively. The trial is particularly important as it addresses cancers linked to HPV-16 infection across multiple sites, including vaginal cancer, offering a potential new treatment option for patients with limited alternatives.
