Squamous cell carcinoma of the vulva Trials in Disease

Study of pembrolizumab and vorinostat combination therapy in patients with recurrent or metastatic squamous cell carcinoma of head and neck, cervix, anus, and genital areas

This trial is testing a combination of two medications for patients whose cancer has returned or spread after previous treatment. The study includes various types of squamous cell carcinomas, including those affecting the vulva and vagina, as well as the head and neck, cervix, anus, and penis.

Who can participate: Adults aged 18 years or older with confirmed squamous cell carcinoma that has returned or spread are eligible. Participants must have disease that can be measured and biopsied. Good overall health is required, including adequate bone marrow function with normal white blood cell counts (at least 1,500/mm³), platelet counts (at least 100,000/mm³), and hemoglobin levels (at least 9 g/dL). Normal kidney and liver function are also necessary. Participants must be able to perform daily activities independently or with minimal restrictions. The ability to swallow oral medications is essential, as is the ability to follow the study schedule and attend appointments. Women who can become pregnant must have a negative pregnancy test within 72 hours before starting treatment. Both men and women must agree to use effective birth control during the study and for several months afterward. Participants must also consent to tumor biopsies and blood sample collection throughout the study.

Who cannot participate: Patients who have previously been treated with pembrolizumab or vorinostat are excluded. Those with active autoimmune diseases requiring systemic treatment or untreated brain metastases cannot participate. A history of severe allergic reactions to monoclonal antibody treatments is also grounds for exclusion. Active infections requiring systemic therapy, known active Hepatitis B or C infection, or known HIV infection disqualify patients from the study. Recent use of corticosteroids or other immunosuppressive medications within 7 days before treatment, or participation in another clinical trial within 4 weeks are not allowed. Pregnant or breastfeeding women are excluded, as are patients with significant heart conditions within the past 6 months. Any condition that could interfere with the ability to swallow oral medications or with understanding study requirements will result in exclusion.

Treatment approach: The study evaluates how well pembrolizumab and vorinostat work together in treating these cancers. Pembrolizumab is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells by blocking a protein called PD-1. It is given through an intravenous infusion at a dose of up to 200 mg. Vorinostat belongs to a group of medications called histone deacetylase inhibitors that affect how genes behave in cancer cells, potentially slowing or stopping their growth. It is taken as oral capsules at a dose of up to 400 mg daily. The treatment period may continue for up to 105 weeks. Throughout the study, doctors monitor how the cancer responds through regular medical examinations and imaging tests. This combination approach aims to provide better results than using either medication alone by combining immune system activation with changes to cancer cell behavior.

Study on the Safety and Effects of Durvalumab and Tremelimumab with Radiotherapy for Patients with Metastatic Squamous Cell Carcinoma

This clinical trial focuses on testing a combination of immunotherapy medications together with a specialized form of radiation therapy for metastatic squamous cell carcinoma. The study includes cancers affecting the vulva, vagina, head and neck, lungs, esophagus, cervix, and anus.

Who can participate: Patients must be 18 years of age or older with confirmed metastatic squamous cell carcinoma in specific areas and must have received previous treatments. Adequate organ function is essential, including sufficient white blood cells called neutrophils (at least 1,500 per mm³), platelets (at least 100,000 per mm³), and hemoglobin levels greater than 9 g/dL. Liver function is assessed through bilirubin levels no more than 1.5 times the normal limit and liver enzyme levels within acceptable ranges. Kidney function must show creatinine clearance greater than 40 mL/min. Participants must have at least one tumor that can be treated with radiation and another that will remain untreated for comparison purposes. At least one tumor must be accessible for biopsy both before and after treatment. A previously collected tumor sample must be available, and tumors must be measurable according to specific medical criteria. Patients must not have had radiation therapy in the area to be treated. A performance status of 0-1 is required, meaning patients are fully active or have some restrictions but can still do light work. Women who can become pregnant must have a negative pregnancy test before starting, and both men and women capable of reproduction must use effective birth control during the study and afterward. Participants must have social security coverage and must be able to understand and follow study procedures.

Who cannot participate: Patients who have had another type of cancer in the past are excluded, with exceptions for certain treated skin cancers. Active infections requiring antibiotic treatment disqualify patients, as do severe allergic reactions to similar medications used in the study. Pregnant or breastfeeding women cannot participate. Autoimmune diseases, where the body's immune system attacks its own healthy cells, are grounds for exclusion. Patients who have received a live vaccine within 30 days before the study start date are not eligible. Serious heart conditions such as heart failure or recent heart attacks, uncontrolled high blood pressure, or a history of drug or alcohol abuse within the past year result in exclusion. Any condition affecting the ability to understand or follow study instructions disqualifies patients. Current participation in another clinical trial is not permitted.

Treatment approach: The trial evaluates the safety and effectiveness of combining two immunotherapy medications with stereotactic body radiotherapy. Durvalumab works by blocking a protein called PD-L1, which helps the immune system recognize and destroy cancer cells more effectively. Tremelimumab blocks a protein called CTLA-4, enhancing the immune system's ability to attack and kill cancer cells. Both medications are administered intravenously directly into the bloodstream. Stereotactic body radiotherapy is a type of radiation treatment that delivers high doses of radiation to cancer cells with precision, minimizing damage to surrounding healthy tissue. The radiation is applied to specific tumor sites while ensuring at least one tumor remains unirradiated for comparison. Throughout the trial, regular monitoring assesses safety and effectiveness, including evaluation of side effects and tumor responses through imaging tests such as CT scans. The study is divided into two phases: the first focuses on safety, while the second examines how well the treatment works in reducing cancer outside the area receiving radiation. Follow-up visits continue for several months after the last dose to monitor long-term health effects.

Summary

Both ongoing clinical trials for squamous cell carcinoma of the vulva are being conducted in France, offering patients access to innovative treatment combinations. The first trial tests pembrolizumab combined with vorinostat, pairing immunotherapy with an oral medication that affects cancer cell genes. The second trial evaluates durvalumab and tremelimumab combined with precision radiation therapy. Both studies focus on immunotherapy approaches that help the body's own immune system fight cancer, representing current advances in cancer treatment. These trials are designed for patients whose cancer has returned or spread after previous treatments, and both require adequate organ function and good overall health status. The availability of these studies in France provides treatment options for patients who meet the specific eligibility criteria and are seeking participation in cutting-edge cancer research.