Metastatic squamous cell carcinoma Trials in Disease

Study on Rigosertib Sodium for Patients with Recessive Dystrophic Epidermolysis Bullosa and Advanced Squamous Cell Carcinoma

This clinical trial is taking place in Austria and focuses on a very specific patient population: people with a rare genetic skin condition called Recessive Dystrophic Epidermolysis Bullosa (RDEB) who have developed advanced squamous cell carcinoma. The study is testing a medication called Rigosertib Sodium, which is being evaluated in two different forms – as an intravenous solution and as oral capsules.

Who can participate: To be eligible for this trial, patients must be between 18 and 79 years old and have a confirmed diagnosis of RDEB through genetic testing or a specialized skin biopsy. They must also have squamous cell carcinoma that cannot be removed by surgery, is locally advanced, or has spread to other parts of the body. Importantly, the cancer must not have responded to standard treatments such as surgery, radiotherapy, or traditional chemotherapy drugs including cisplatin, carboplatin, 5-fluorouracil, and others. Patients who have not responded to newer treatments like epidermal growth factor inhibitors or immune checkpoint inhibitors may also qualify. Participants must not be receiving any other cancer treatment at the time of enrollment and must have measurable disease according to standard cancer measurement guidelines.

Who cannot participate: Patients who do not have RDEB associated with the specific type of squamous cell carcinoma being studied are excluded. Those outside the specified age range, pregnant or breastfeeding women, and patients participating in another clinical trial simultaneously cannot join. People who have had recent major surgery, have a history of allergic reactions to the study medication, have not recovered from side effects of previous treatments, or have certain infections or other medical conditions that could interfere with the study are also excluded.

Study focus and treatment: The main goal of this trial is to assess the safety and effectiveness of Rigosertib Sodium in patients whose cancer has not responded to standard treatments. The medication works by blocking certain pathways in the body that cancer cells use to grow. Participants will receive the treatment either orally or through an infusion. The oral form involves taking capsules daily for three weeks followed by a one-week break. The infusion form is given continuously over 72 hours on the first three days of treatment cycles. The study will last up to 52 weeks, during which doctors will monitor how well the cancer responds using imaging scans like CT or MRI. The trial will also evaluate the impact on patients' quality of life and analyze biological markers related to the disease.

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

This clinical trial is being conducted in France and studies a combination treatment approach for patients with metastatic squamous cell carcinoma that can occur in various parts of the body including the head and neck, lungs, esophagus, cervix, vagina, vulva, or anus. The study tests two medications – Durvalumab and Tremelimumab – given together with a precise form of radiation therapy called stereotactic body radiotherapy (SBRT).

Who can participate: Patients must be at least 18 years old and have adequate organ function, including sufficient levels of white blood cells, platelets, hemoglobin, and proper liver and kidney function. They must have a confirmed diagnosis of metastatic squamous cell carcinoma in one of the specified areas and must have been previously treated with other therapies. Eligible patients need to have at least one tumor that can be treated with radiation and another that will not receive radiation, as well as at least one tumor that can be biopsied before and after treatment. The cancer must be measurable according to standard criteria, and patients must not have had radiation therapy in the area to be treated. Patients need to be fully active or have only minimal restrictions in their daily activities. Both men and women of childbearing potential must use effective birth control during the study.

Who cannot participate: Patients who have had another type of cancer in the past (with some exceptions for certain treated skin cancers) are excluded. Those with active infections requiring antibiotics, a history of severe allergic reactions to similar medications, or autoimmune diseases cannot participate. Pregnant or breastfeeding women are excluded, as are patients who have received a live vaccine within 30 days before starting the study. People with serious heart conditions, uncontrolled high blood pressure, recent drug or alcohol abuse, or those currently participating in another clinical trial are also not eligible.

Study focus and treatment: The trial aims to evaluate the safety and effectiveness of combining two immune system-boosting medications with radiation therapy. Durvalumab works by blocking a protein called PD-L1, which helps the immune system recognize and destroy cancer cells more effectively. Tremelimumab blocks a different protein called CTLA-4, enhancing the immune system's ability to attack cancer cells. These medications are given as infusions directly into the bloodstream. The stereotactic body radiotherapy delivers high doses of radiation precisely to cancer cells while minimizing damage to surrounding healthy tissue. Throughout the trial, regular monitoring is conducted to assess safety, side effects, and how the tumors respond to treatment. The study includes both a safety evaluation phase and a phase that looks at how well the treatment works in reducing cancer outside the area that receives radiation.

Summary

These two ongoing clinical trials represent different approaches to treating metastatic squamous cell carcinoma in distinct patient populations. The Austrian trial focuses on a very specific group of patients with a rare genetic skin condition who have developed cancer, testing a single investigational drug that can be given orally or intravenously. The French trial takes a combination approach, using two immune-boosting medications together with targeted radiation therapy for a broader population of patients with metastatic squamous cell carcinoma in various body locations.

Both studies are designed for patients whose cancer has not responded to standard treatments, offering potential new options where conventional therapies have been unsuccessful. The trials are conducted in different European countries and use different treatment mechanisms – one focusing on blocking cancer growth pathways directly, while the other aims to enhance the body's immune response against cancer cells. Patients interested in participating should discuss their eligibility with their healthcare providers, as each trial has specific requirements regarding previous treatments, organ function, and other health factors.