Study on Cisplatin, Pembrolizumab, and Radiation Therapy for Vulvar Cancer

Sponsor: Massachusetts General Hospital

Sponsor score: 0

ClinicalTrials ID:NCT04430699

This clinical trial is exploring a combination of standard and investigational treatments, including cisplatin, pembrolizumab, and radiation therapy, to see how well they work together against vulvar squamous cell carcinoma that cannot be surgically removed.

Patient Parameters

Parameter	Options

Program Overview

The purpose of this study is to find out if combining a standard chemotherapy drug (cisplatin), an investigational drug (pembrolizumab), and radiation therapy can effectively treat vulvar squamous cell carcinoma that cannot be removed by surgery. The study will involve screening for eligibility, receiving the treatment, and attending follow-up visits. Participants will receive the treatment for up to 36 weeks and will be monitored for up to 3 years. About 24 people are expected to participate in this study. Cisplatin is already approved for treating vulvar cancer, while pembrolizumab is approved for other uses but is still being studied for this type of cancer.

Description

This study is a Phase II clinical trial for women with vulvar squamous cell carcinoma that cannot be fully removed by surgery, has returned, or has spread to other parts of the body. The trial combines cisplatin, pembrolizumab, and radiation therapy to see if this combination can help the immune system fight the cancer more effectively and reduce the chances of the cancer coming back. Participants will be screened to ensure they meet the study criteria and will receive the treatment for up to 36 weeks, with follow-up visits for up to 3 years. The study aims to test the safety and effectiveness of this treatment combination. Cisplatin is a chemotherapy drug that is part of the standard care for this cancer, while pembrolizumab is an investigational drug that may help the immune system target and kill cancer cells. Radiation therapy is also part of the standard care and will be used in this study.

Eligibility Criteria

Inclusion Criteria

Have a confirmed diagnosis of vulvar squamous cell carcinoma that cannot be fully removed by surgery, has returned, or has spread.
Have measurable cancer that can be tracked using standard criteria.
Provide a tumor sample from a biopsy or surgery.
Have not received more than two lines of chemotherapy for recurrent cancer.
Be 18 years or older.
Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Have adequate organ and blood function as determined by specific tests.
Be female, not pregnant or breastfeeding, and agree to use effective contraception if of childbearing potential.
Understand the study and agree to sign informed consent.

Exclusion Criteria

Cannot safely receive a minimum of 30 Gy in 10 fractions of radiation.
Have received other cancer treatments within 4 weeks before starting the study treatment.
Have not recovered from side effects of previous treatments to a mild level.
Have received radiation therapy within 2 weeks before starting the study treatment.
Have received a live vaccine within 30 days before starting the study treatment.
Have certain types of vulvar cancer, such as melanomas or sarcomas.
Have a history of certain medical conditions, such as autoimmune diseases requiring treatment, active infections, or other cancers within the last 5 years.
Have active brain metastases or a history of pneumonitis.
Have a known history of Hepatitis B, Hepatitis C, or active tuberculosis.
Be pregnant or breastfeeding.
Have any condition that might interfere with the study or is not in the best interest of the participant to join, according to the investigator.

Locations

FACILITY	ZIP	CITY	STATE
Massachusetts General Hospital Cancer Center	02114	Boston	Massachusetts

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.