View clinical trials related to Vulvar Neoplasms.
Filter by:This is a multicenter, open-label, phase II clinical study, aiming to the evaluate the efficacy and safety of AK104, an anti- PD-1 and CTLA-4 bispecific antibody, in subjects with recurrent or metastatic vulvar cancer not amenable to curative surgery or radiotherapy.
Electrochemotherapy is a local treatment modality with effectiveness comparable to other local ablation techniques. With electrochemotherapy 80% objective response can be achieved and is suitable for the treatment of different types of tumors. The method is based on increased drug delivery to cells previously exposed to electroporation. The most commonly used cytotoxic agents are bleomycin and cisplatin. The aim of the proposed clinical trial is to determine the efficacy, feasibility and safety of electrochemotherapy in the treatment of vulvar cancer.
ICK-Gyn is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under immune checkpoint inhibitor (ICI) therapy on the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).
A phase 2 randomised controlled trial will be performed in which the efficacy and safety of standard treatment (primary chemoradiation; consisting of 64.5 Gy in 30 fractions of external beam radiotherapy with weekly cisplatin for six weeks) and experimental treatment (NACT; consisting of carboplatin and paclitaxel in a 3-weekly scheme) will be compared in 98 patients with LAVC, registered from eight national medical centres.
Evaluation of efficacy and safety of pembrolizumab in combination with lenvatinib in patients with recurrent, persistent, metastatic or locally advanced vulva cancer.
This prospective study evaluated the clinical implementation value of an optical surface monitoring system (OSMS) in the radiotherapy setup for patients with vulvar cancer, compared to standard laser-based setup
A single center, open, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of HRYZ-T101 TCR-T cell for HPV18 positive advanced solid tumor. The study will investigate DLT of HRYZ-T101 TCR-T cell injection.
This clinical trial studies how well an electronic (e)-health intervention (day-by-day) woks in managing fears or worries about cancer growing, spreading, or getting worse (progression) in patients with stage III or IV gynecologic cancer. Fear and worries about cancer progression or recurrence (coming back) are common concerns. This may contribute to concerns related to illness, worries, and uncertainty about the future. Day by Day is adapted from a program called "Conquer Fear" which was shown to benefit patients with early-stage cancer. Day-by-day intervention may help refocus patient thoughts and help patients learn skills to manage anxiety and fears.
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.
The primary purpose of the study is to determine which of four components (symptom-burden tailored app, exercise partner, oncology provider engagement, coaching) added to a core intervention of a wearable activity tracker and commercially available app, will improve physical activity. The findings will generate meaningful knowledge about how to best increase physical activity in older gynecologic cancer patients receiving systemic cancer therapies to improve quality of life and cancer-specific survival.