Cisplatin+Pembrolizumab+RT in Vulvar Cancer

Status Recruiting

Clinical Trial Summary

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)

Clinical Trial Description

This is a single-arm phase 2 clinical trial involving women with unresectable, incompletely resected, recurrent, or metastatic vulva squamous cell carcinoma. This study combines cisplatin, pembrolizumab, and radiation therapy to see if this combination further increases participants' immune system's efficiency in killing their tumor, and if the combination decreases the chances of participants' cancer coming back. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. This research study involves the following: - Cisplatin (standard of care drug) - Pembrolizumab (investigational drug) - Radiation Therapy (standard of care intervention) Participants will receive study treatment for up to 36 weeks and will be followed for up to 3 years. It is expected that about 24 people will take part in this research study. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has approved cisplatin as a treatment option for vulva squamous cell carcinoma. The FDA has not approved pembrolizumab for vulva squamous cell carcinoma, but it has been approved for other uses. Cisplatin is a chemotherapy drug and will be given to participants per standard of care. Radiation therapy will be given to you per standard of care. Pembrolizumab is a drug that may target participants immune systems to increase its efficiency in targeting and killing illnesses and diseases, such as unresectable vulvar squamous cell carcinoma. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04430699
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Oladapo Yeku, MD, PHD
Phone	617-643-9354
Email	oyeku@mgh.harvard.edu
Status	Recruiting
Phase	Phase 2
Start date	July 29, 2020
Completion date	January 30, 2028

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