Ongoing Clinical Trials for Squamous Cell Carcinoma of the Vagina
Currently, there is 1 ongoing clinical trial investigating treatment options for squamous cell carcinoma of the vagina. This trial is testing a combination of immunotherapy medications (Durvalumab and Tremelimumab) alongside targeted radiation therapy for patients with metastatic disease.
Clinical trial locations
Study on the Safety and Effects of Durvalumab and Tremelimumab with Radiotherapy for Patients with Metastatic Squamous Cell Carcinoma
This trial is examining a combination treatment approach for metastatic squamous cell carcinoma, which includes vaginal cancer that has spread to other parts of the body. The study tests two immunotherapy drugs, Durvalumab and Tremelimumab, used together with a precise form of radiation therapy called stereotactic body radiotherapy (SBRT).
Main focus and goals: The trial aims to evaluate how safe this combination treatment is and how well it works in fighting cancer. The study is divided into two phases: the first focuses on safety monitoring, while the second examines how effectively the treatment reduces cancer in areas outside where radiation is applied. Researchers will use imaging tests like CT scans throughout the study to track tumor response and monitor any changes in patients’ conditions.
Investigational drugs: The trial uses Durvalumab (also known by its code name MEDI4736), which works by blocking a protein called PD-L1 that can prevent the immune system from attacking cancer cells. The second medication, Tremelimumab, blocks another protein called CTLA-4, which can slow down immune responses. By blocking these proteins, both drugs help the immune system better recognize and destroy cancer cells. These medications are given as infusions directly into the bloodstream and are used alongside SBRT, which delivers high doses of radiation precisely to cancer cells while minimizing damage to healthy tissue.
Who can participate: Patients must be at least 18 years old with confirmed metastatic squamous cell carcinoma that has been previously treated. They need to have adequate organ function, including sufficient white blood cells (at least 1,500 neutrophils per mm³), platelets (at least 100,000 per mm³), hemoglobin greater than 9 g/dL, and proper kidney function with creatinine clearance greater than 40 mL/min. Liver enzymes (ALT and AST) must be no more than 2.5 times the normal limit, or 5 times if liver metastases are present. Bilirubin should be no more than 1.5 times normal, except for patients with Gilbert’s syndrome.
Patients must have at least one tumor suitable for radiation treatment and another that will not receive radiation for comparison. At least one tumor must be accessible for biopsy both before and after treatment. A previously collected tumor sample must also be available. The tumors need to be measurable according to specific medical criteria called RECIST 1.1. Patients must not have received radiation therapy in the area to be treated and must wait a certain period since their last cancer treatment before joining the study. They should have a performance status of 0-1, meaning they can carry out normal activities or have only minor restrictions.
Women who can become pregnant must have a negative pregnancy test before starting, and both men and women of childbearing potential must use effective birth control during the study and for a period afterward. Patients must be willing to follow study procedures, understand and sign a consent form, and have social security coverage.
Who cannot participate: The trial excludes patients who have had another type of cancer in the past (except for certain treated skin cancers), those with active infections requiring antibiotic treatment, or anyone with a history of severe allergic reactions to similar medications. Pregnant or breastfeeding women cannot participate. Patients with autoimmune diseases, where the body’s immune system attacks its own healthy cells, are not eligible.
The study also excludes those who received a live vaccine within 30 days before the trial start (live vaccines contain small amounts of actual virus or bacteria). Patients with conditions affecting their ability to understand or follow study instructions, serious heart conditions like heart failure or recent heart attack, uncontrolled high blood pressure, or a history of drug or alcohol abuse within the past year cannot join. Those currently participating in another clinical trial are also excluded.
Summary
Currently, only one clinical trial is available for patients with squamous cell carcinoma of the vagina, taking place in France. This trial focuses on an innovative combination approach using two immunotherapy drugs alongside targeted radiation therapy for metastatic disease. The study represents an important investigation into how immunotherapy can be combined with precision radiation to potentially improve outcomes for patients whose cancer has spread beyond its original location. The trial is specifically designed for patients who have already received previous treatment and have disease that meets specific criteria for both radiation and biopsy procedures.
