Ongoing Clinical Trials for Vulval Cancer
This article provides detailed information about 6 ongoing clinical trials for vulval cancer (also known as vulvar cancer). These studies are testing different treatment approaches including chemotherapy combined with radiation, immunotherapy drugs, and combinations of targeted therapies. The trials are being conducted across multiple countries in Europe.
Clinical trial locations
- Belgium
- Czechia
- France
- Germany
- Italy
- Netherlands
- Study Comparing Chemoradiation and Chemotherapy with Cisplatin, Paclitaxel, and Carboplatin for Patients with Advanced Vulvar Cancer
- Study of Pembrolizumab for Patients with Vulvar Squamous Cell Carcinoma
- Study on the Safety of Using Chemoradiation with Cisplatin and Carboplatin for Early-Stage Vulvar Cancer Patients with Macrometastasis in Sentinel Lymph Node
- Spain
- Sweden
Study Comparing Chemoradiation and Chemotherapy with Cisplatin, Paclitaxel, and Carboplatin for Patients with Advanced Vulvar Cancer
This trial is comparing two different treatment approaches for locally advanced disease. Patients must be women aged 18 or older with a confirmed diagnosis of squamous cell carcinoma at FIGO stage Ib to IVa. The cancer must require either primary chemoradiation or extensive surgery. Eligible patients need to have good overall health, with adequate blood, liver, and kidney function. Women who can become pregnant must use highly effective birth control and have a Beta HCG level below 14 mIU/mL.
The trial excludes patients who do not have locally advanced disease requiring the specified treatments, those who are not female, and those considered part of a vulnerable population requiring special care.
The study focuses on evaluating two treatment strategies: primary chemoradiation versus neoadjuvant chemotherapy followed by surgery. The goal is to determine which approach is more effective in treating locally advanced disease while preserving quality of life and organ function. The trial also examines how HPV status influences treatment outcomes.
The investigational drugs used include cisplatin, paclitaxel, and carboplatin. These chemotherapy medications are given through intravenous infusion. Cisplatin and carboplatin work by stopping cancer cell growth, while paclitaxel helps prevent cancer cells from dividing. The trial is expected to continue until 2029.
Study of Pembrolizumab and Lenvatinib for Patients with Advanced Vulvar Cancer Not Suitable for Surgery or Radiotherapy
This German trial is designed for patients with recurrent, persistent, or metastatic disease that cannot be treated with curative surgery or radiation. Patients must be women at least 18 years old who have had no more than two previous chemotherapy treatments for advanced or spreading cancer. The disease must be measurable, and participants need good organ function and an ECOG performance status that allows them to carry out light activities. Women who can become pregnant must use effective birth control and not be pregnant or breastfeeding. A tumor tissue sample must be provided.
Exclusions include patients without the specified cancer types, males, and those in vulnerable populations.
The main focus is evaluating how well the combination of pembrolizumab and lenvatinib works in treating advanced disease. The study measures how many patients experience a reduction or complete disappearance of their cancer within 24 weeks of starting treatment. Quality of life assessments are also conducted throughout the trial.
The trial uses pembrolizumab, an immunotherapy given by intravenous infusion that helps the immune system fight cancer by blocking the PD-1 pathway. Lenvatinib is taken orally as capsules and works by blocking proteins that help cancer cells grow and interfering with their blood supply.
Study of Pembrolizumab for Patients with Vulvar Squamous Cell Carcinoma
This Dutch trial is for patients with vulvar squamous cell carcinoma that is suitable for primary surgery. Women must be at least 18 years old with a confirmed diagnosis and at least one measurable tumor of 10mm or larger. The cancer should be at FIGO stage I-III without distant spread. Patients need good organ function and an ECOG performance status of 0-1, meaning they can be fully active or have some symptoms but can still do light work. Women who can become pregnant must use highly effective birth control or abstain from heterosexual intercourse.
The trial excludes males, patients without vulvar squamous cell carcinoma, and those in vulnerable populations.
This study explores using pembrolizumab before surgery to reduce tumor size. Researchers monitor how effector T cells, which are part of the immune system, respond to treatment. The first tumor assessment occurs approximately six weeks after the first dose. The trial gathers information on the safety and effectiveness of this approach.
The investigational drug is pembrolizumab (KEYTRUDA), given as an intravenous infusion. It works by blocking the PD-1 pathway, enhancing the immune system’s ability to detect and attack cancer cells.
Study on the Safety of Using Chemoradiation with Cisplatin and Carboplatin for Early-Stage Vulvar Cancer Patients with Macrometastasis in Sentinel Lymph Node
This trial is investigating whether chemoradiation can safely replace inguinofemoral lymphadenectomy, a surgical procedure that removes groin lymph nodes. It is for early-stage patients with a macrometastasis (cancer spread larger than 2mm) in the sentinel lymph node. Eligible patients must be women 18 or older with confirmed primary squamous cell carcinoma, a single T1 tumor less than 4cm in diameter, and good performance status. They must have adequate organ function and no enlarged or suspicious groin lymph nodes on imaging tests.
Exclusions include patients who don’t have the specified cancer type, are not female, don’t have macrometastasis in the sentinel lymph node, or are in vulnerable populations.
The study’s main goal is to see if chemoradiation can prevent cancer recurrence in the groin area while also examining treatment-related side effects, disease-specific survival, and quality of life. The trial continues until March 2029.
The investigational drugs are cisplatin and carboplatin, both given as intravenous infusions. These chemotherapy drugs work by damaging the DNA of cancer cells, preventing them from growing and dividing. The trial also involves radiation therapy, which uses high-energy rays to destroy cancer cells.
Study of pembrolizumab and lenvatinib treatment for patients with vulvar cancer
This Italian trial tests a combination treatment for different patient groups: those with tumors that cannot be surgically removed, those who have never received chemotherapy for recurrent or spreading cancer, and those whose cancer has returned after previous treatment or has spread despite chemotherapy. Eligible participants must be female, at least 18 years old, with confirmed cancer that has spread or returned. They must have at least one measurable tumor, good physical function, normal organ and bone marrow function, and well-controlled blood pressure (140/90 or lower). Women who can become pregnant must have a negative pregnancy test and use highly effective birth control.
Exclusions include patients under 18, males, pregnant or breastfeeding women, those with active or untreated brain metastases, other cancers within the past 2 years, severe heart conditions, severe kidney disease requiring dialysis, active autoimmune disease, active infections requiring systemic treatment, previous treatment with similar medications, and various other medical or social conditions that would interfere with participation.
The trial evaluates how well the medications work together and their safety. Response to treatment is evaluated after 4 cycles for patients with primary tumors. The study continues until September 2031, with regular monitoring throughout.
The trial uses pembrolizumab (KEYTRUDA), given by intravenous infusion at 200 mg, which blocks the PD-1 protein to help the immune system attack cancer cells. Lenvatinib is taken daily as 20 mg capsules and works by blocking proteins that help cancer cells grow and survive, specifically interfering with new blood vessel formation that feeds tumors.
Study of TG4001 and Avelumab for Patients with Advanced HPV-16 Positive Cancers
This trial, conducted in France and Spain, studies cancers linked to HPV-16, including those affecting the head and neck, cervix, vulva, vagina, penis, and anus. Patients must be at least 18 years old with HPV-16 positive cancer that has spread or returned after treatment. They need an ECOG performance status of 0 or 1, a life expectancy of at least 3 months, and at least one lesion measurable by CT scan. For patients with liver spread, there should be no more than 3 liver lesions, with the largest being 30mm or smaller. Women who can become pregnant must have a negative pregnancy test and use highly effective birth control during the study and for 3 months afterward. Patients must have adequate blood, liver, and kidney function. The number of prior chemotherapy treatments allowed varies by study phase.
Exclusions include patients with liver metastases at the start, those not positive for HPV-16, and those without recurrent or metastatic cancer of the specified types.
The study has two phases. Phase Ib focuses on understanding the safety and tolerability of the combination treatment. Phase II evaluates how well the combination works in slowing cancer progression compared to using avelumab alone. The trial is expected to conclude by December 31, 2026.
The investigational drugs are TG4001, a therapeutic vaccine given as a subcutaneous injection that stimulates the immune system to recognize and attack HPV-16 positive cancer cells, and avelumab, given as an intravenous infusion at 20 mg/mL. Avelumab is a checkpoint inhibitor that blocks the PD-L1 protein, helping the immune system detect and destroy cancer cells.
Summary
Currently, there are 6 ongoing clinical trials for vulval cancer being conducted across Europe. The Netherlands has the highest concentration of trials with 3 studies, followed by Belgium, France, and Spain with 2 trials each. Single trials are taking place in Germany, Italy, Sweden, and Czechia.
A notable trend is the focus on immunotherapy approaches, with 4 out of 6 trials involving pembrolizumab, either alone or in combination with other drugs. Three trials specifically test the combination of pembrolizumab with lenvatinib for different patient populations. Traditional chemotherapy combined with radiation remains an important treatment option, as shown by two trials investigating chemoradiation with cisplatin and carboplatin.
The trials address different stages and situations: some focus on early-stage disease, others on locally advanced cases, and several target recurrent, persistent, or metastatic disease. One innovative trial explores HPV-16 positive cancers using a therapeutic vaccine approach. The diversity of these studies reflects ongoing efforts to find more effective and less invasive treatment options while preserving quality of life for patients.
