Ongoing Clinical Trials for Squamous Cell Carcinoma of the Cervix

This article provides information about 2 ongoing clinical trials testing new treatment combinations for squamous cell carcinoma of the cervix. These trials are evaluating immunotherapy drugs combined with other medications or radiotherapy to help the body’s immune system fight cancer more effectively.

Clinical trial locations

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

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 treating squamous cell carcinoma that has either returned after treatment or spread to other parts of the body. The study includes cancers of the cervix, as well as other areas such as the head and neck, anus, and genital regions.

Main inclusion criteria: Participants must be at least 18 years old and have confirmed squamous cell carcinoma that has returned or spread. They must have adequate bone marrow, liver, and kidney function, with specific requirements including white blood cell count of at least 1,500/mm³, platelet count of at least 100,000/mm³, and hemoglobin of at least 9 g/dL. The disease must be measurable and accessible for biopsy. Participants must be able to perform daily activities with an ECOG performance score of 0 or 1, meaning they are either fully active or able to carry out light work. Women of childbearing age must have a negative pregnancy test, and both men and women must use effective birth control during the study and for several months afterward. Participants must be able to swallow medications and follow the study schedule.

Main exclusion criteria: The trial excludes individuals who have previously been treated with pembrolizumab or vorinostat. Those with active autoimmune diseases requiring systemic treatment, untreated brain metastases, or active infections are not eligible. People with a history of severe allergic reactions to monoclonal antibody treatments, known active Hepatitis B or C, or HIV infection cannot participate. Individuals who have used corticosteroids or other immune-suppressing medications within 7 days before starting treatment, or who participated in another clinical trial within 4 weeks, are excluded. Pregnant or breastfeeding women, those with significant heart conditions in the past 6 months, and individuals unable to swallow oral medications or with psychiatric conditions that would interfere with participation are also excluded.

Focus and goal: The study evaluates how well pembrolizumab and vorinostat work together in treating various types of squamous cell carcinoma. Treatment may continue for up to 105 weeks, during which doctors monitor how the cancer responds through regular medical examinations and imaging tests. The trial involves receiving pembrolizumab as an intravenous infusion at doses up to 200 mg, along with vorinostat capsules at doses up to 400 mg daily. Participants undergo tumor biopsies to confirm diagnosis, regular blood sampling, and ongoing monitoring for side effects. The study tracks whether tumors shrink completely, partially, or remain stable, providing important information about this combination approach.

Investigational drugs: Pembrolizumab is an immunotherapy medication given through intravenous infusion that helps the immune system recognize and attack cancer cells. It works by blocking a protein called PD-1, which normally prevents immune cells from attacking cancer. Vorinostat is an oral medication taken as capsules that belongs to a group called histone deacetylase inhibitors. It affects how genes behave in cancer cells, which can slow or stop their growth and may make cancer cells more visible to the immune system. Together, these medications aim to provide better results than using either one alone.

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

This clinical trial focuses on metastatic squamous cell carcinoma, which can occur in the cervix and several other areas including the head and neck, lungs, esophagus, vagina, vulva, or anus. The study tests a combination of two medications given together with a specialized form of radiation therapy.

Main inclusion criteria: Patients must be 18 years or older with confirmed metastatic squamous cell carcinoma who have been previously treated. They must have adequate organ function, including neutrophil count of at least 1,500 per mm³, platelet count of at least 100,000 per mm³, and hemoglobin greater than 9 g/dL. Liver function tests must show bilirubin no more than 1.5 times the normal limit, and liver enzymes no more than 2.5 times normal, or 5 times if liver metastases are present. Kidney function must show creatinine clearance greater than 40 mL/min. Patients must have at least one tumor suitable for radiation treatment and another that will not receive radiation, as well as at least one tumor that can be biopsied before and after treatment. A previously collected tumor sample must be available. Tumors must be measurable according to specific criteria, and patients must not have had radiation therapy in the area to be treated. A performance status of 0-1 is required, meaning patients can be fully active or have some restrictions but can still do light work. Female patients must be unable to have children or have a negative pregnancy test, and both men and women of reproductive age must use effective birth control.

Main exclusion criteria: 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, a history of severe allergic reactions to similar medications, or who are pregnant or breastfeeding cannot participate. Patients with autoimmune diseases, those who received a live vaccine within 30 days before starting the study, or those with conditions affecting their ability to understand or follow study instructions are excluded. Individuals with serious heart conditions such as heart failure or recent heart attack, uncontrolled high blood pressure, or a history of drug or alcohol abuse within the past year are not eligible. Those currently participating in another clinical trial are also excluded.

Focus and goal: The study evaluates the safety and effectiveness of durvalumab and tremelimumab when combined with stereotactic body radiotherapy, a precise form of radiation treatment that targets tumors while minimizing damage to surrounding healthy tissue. The trial 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. Throughout the study, participants undergo regular monitoring including imaging tests like CT scans to track cancer progression and any treatment-related side effects. The radiotherapy is applied to specific tumor sites while ensuring at least one tumor remains untreated for comparison purposes. Follow-up visits continue for several months after the last medication dose to monitor long-term effects.

Investigational drugs: Durvalumab is administered intravenously and works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. By blocking this protein, durvalumab helps the immune system recognize and destroy cancer cells more effectively. Tremelimumab is also given intravenously and works by blocking a protein called CTLA-4, which can slow down the immune response. By inhibiting this protein, tremelimumab enhances the immune system’s ability to attack and kill cancer cells. Both medications are monoclonal antibodies designed to boost the immune system’s cancer-fighting abilities. They are used in combination with stereotactic body radiotherapy to enhance treatment effectiveness.

Summary

Both clinical trials for squamous cell carcinoma of the cervix are currently taking place in France. These studies represent important research into combination therapies that aim to harness the power of the immune system to fight cancer more effectively.

The first trial combines pembrolizumab with vorinostat, testing an immunotherapy drug together with a medication that affects gene expression in cancer cells. The second trial combines two immunotherapy drugs, durvalumab and tremelimumab, with precise radiation therapy. Both studies focus on treating cancer that has either returned after previous treatment or spread to other parts of the body.

A notable aspect of these trials is their focus on immunotherapy approaches, which work by helping the body’s own immune system recognize and attack cancer cells rather than directly targeting the cancer. Both studies require participants to have adequate organ function and exclude those with active autoimmune diseases, reflecting the immune-based nature of these treatments. The trials also demonstrate careful attention to safety through detailed exclusion criteria and ongoing monitoring throughout the treatment period.

These trials may offer new treatment options for patients whose cancer has progressed despite previous therapy, though participation requires meeting specific health criteria and the ability to attend regular study visits and follow-up appointments.