View clinical trials related to Vulva Cancer.
Filter by:Doctors typically use blue dye to assist in locating and extracting lymph nodes for biopsy. However, this process can prove somewhat challenging for both patients and medical teams due to its need for extensive coordination and the assistance of a nuclear medicine team. Some studies have talked about using a different method to find these lymph nodes using a special dye called Indocyanine Green (ICG). This method involves shining a special camera on the skin. So far, no studies have directly compared the ICG method to the standard blue dye. The ICG camera could make things easier for patients and doctors, and more patients might choose to have their lymph nodes checked with this new method. The goal of our study is to see if using the ICG dye is just as good as the standard method of blue dye.
Rationale: Vulvar squamous cell carcinoma (VSCC) is a rare cancer with a rising incidence. Standard treatment comprises wide local excision of the primary tumour and inguinal lymph nodes and sometimes (chemo) radiotherapy. Treatment is associated with impressive and long-lasting morbidity, sexual and psychological dysfunction and wound healing disorders. Recurrent disease develops in up to 40% of all treated patients. The unmet need, therefore, is a less radical and more effective treatment for VSCC. Hypothesis: Based on the local immune profile in a large fraction of patients with primary VSCC the investigators hypothesize that neoadjuvant PD-1 checkpoint inhibition may reinvigorate tumor-specific T cells resulting in a reduced tumor load, potentially leading to less radical surgery and reduces the recurrence rate. The primary objectives of this trial are to study clinical efficacy and immune activation of neoadjuvant PD-1 blockade in VSCC. Study design: This is a prospective, multicenter phase II non-controlled clinical trial in 40 VSCC patients. Study population: Clinically diagnosed FIGO I-III primary VSCC patients to be treated with surgery with curative intent. Intervention (if applicable): Anti-PD1 antibody pembrolizumab, 200 mg IV Q3W for a total of 2 administrations per patient over a period of 6 weeks prior to surgery. Main study parameters/endpoints: The primary endpoints are: - Clinical efficacy of neoadjuvant PD-1 blockade in VSCC, measured by objective change in tumour size (according to RECIST1.1) - The activation, proliferation and migration of the CD4+CD39+PD-1+ intratumoral T-cell population.