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Vulvar Neoplasms clinical trials

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NCT ID: NCT05105087 Recruiting - Cervical Carcinoma Clinical Trials

Gynecological Sentinel Lymph Nodes CEUS

Start date: April 28, 2022
Phase: Early Phase 1
Study type: Interventional

This clinical trial compares the use of ultrasound for the detection of sentinel lymph nodes (SLNs) to the standard of care (which varies depending on cancer treatment). The ultrasound contrast agent is called Sonazoid and it consists of tiny gas-filled bubbles about the side of red blood cells. Diagnostic procedures, such as ultrasound with Sonazoid, may help identify more SLNs than standard of care in patients with cervical, vaginal, or vulvar cancer.

NCT ID: NCT05076942 Recruiting - Vulvar Cancer Clinical Trials

Groningen International Study on Sentinel Nodes in Vulvar Cancer-III

GROINSS-VIII
Start date: January 1, 2021
Phase: Phase 2
Study type: Interventional

Vulvar cancer patients with SN-metastasis > 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.

NCT ID: NCT05014191 Recruiting - Radiation Toxicity Clinical Trials

Treatment Positioning in Vulvar Cancer Radiation Therapy

Start date: July 1, 2020
Phase:
Study type: Observational

The study investigators will conduct a prospective study on patients with non-metastatic vulvar cancer who will receive radiation treatment using Volumetric Arc Therapy (VMAT) modality with curative intent. Our aim is to compare straight-leg versus frog-leg position in terms of RTOG acute skin toxicity. Also, the study investigators will evaluate if positioning has an impact on the total treatment time and deviation on Cone Beam CT (CBCT) that might warrant re-simulation and consequently re-planning.

NCT ID: NCT05000294 Recruiting - Breast Cancer Clinical Trials

Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types

Start date: December 7, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies. Despite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically "cold" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer. Vascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer. Through the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.

NCT ID: NCT04977453 Recruiting - Clinical trials for Non-small Cell Lung Cancer

GI-101 as a Single Agent or in Combination With Pembrolizumab, Lenvatinib or Local Radiotherapy in Advanced Solid Tumors

Start date: August 2, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A as a single agent or in combination with pembrolizumab, lenvatinib or local radiotherapy (RT) over a range of advanced and/or metastatic solid tumors.

NCT ID: NCT04895020 Recruiting - Cervical Cancer Clinical Trials

Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years

Start date: May 28, 2021
Phase: Phase 3
Study type: Interventional

This phase 3 study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese females aged 9 to 45 years

NCT ID: NCT04761146 Recruiting - Vulva Cancer Clinical Trials

A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer

DaRT-V
Start date: February 28, 2023
Phase: N/A
Study type: Interventional

An investigation to investigate the use of diffusing alpha-emitters radiation therapy (DaRT) for the treatment of new and recurrent squamous cell carcinoma of the vulva.

NCT ID: NCT04708470 Recruiting - Cervical Cancer Clinical Trials

A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers

Start date: October 5, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Often, metastatic human papillomavirus (HPV) associated cancers cannot be cured. They also do not respond well to treatment. Some forms of colon cancer also have poor responses to treatment. Researchers want to see if a new drug treatment can help people with these types of cancers. Objective: To find a safe dose of entinostat in combination with NHS-IL12 and bintrafusp alfa and to see if this treatment will cause tumors to shrink. Eligibility: Adults ages 18 and older who have cervical, oropharyngeal, anal, vulvar, vaginal, penile, squamous cell rectal, or another cancer that may be associated with HPV infection or microsatellite stable small bowel or colorectal cancer. Design: Participants will be screened with a medical history and physical exam. Their ability to do daily activities will be assessed. They may have imaging scans of the brain and/or chest, abdomen, and pelvis. They may have nuclear bone scans. They will have an electrocardiogram to test heart function. They will have blood and urine tests. They may have a tumor biopsy. Participants with skin lesions may have them photographed. Some screening tests will be repeated during the study. Treatment will be done in 28-day cycles. Participants will get bintrafusp alfa through an intravenous catheter every 2 weeks. They will get NHS-IL12 as an injection under the skin every 4 weeks. They will take entinostat by mouth once a week. They will complete a medicine diary. Participants will get treatment for 2 years. They will have 1-2 follow-up visits in the 30 days after treatment ends. Then they will be contacted every 6 months to check on their health.

NCT ID: NCT04663412 Recruiting - Vulvar Cancer Clinical Trials

Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer

Start date: July 9, 2020
Phase: N/A
Study type: Interventional

The potential of the administration of indocyanine green (ICG) allows the execution of SLN biopsy, avoiding the multiple administrations of radiocolloid in the pre-operative phase, painful for the patient, elimination, and exposure to radioactivity. Therefore, while requiring standardization of the methodology and a large-scale application, this procedure could open a new surgical management perspective in patients with early-stage vulvar cancer.

NCT ID: NCT04430699 Recruiting - Vulvar Cancer Clinical Trials

Cisplatin+Pembrolizumab+RT in Vulvar Cancer

Start date: July 29, 2020
Phase: Phase 2
Study type: Interventional

This research is being done to see how well the combination of a standard of care drug, investigational drug, and radiation therapy work against unresectable vulvar squamous cell carcinoma. This research study involves the following: - Cisplatin (standard of care drug) - Pembrolizumab (investigational drug) - Radiation Therapy (standard of care intervention)