NCT04430699

Cisplatin+Pembrolizumab+RT in Vulvar Cancer

A Phase 2 Study of Combined Chemo-immunotherapy With Cisplatin-pembrolizumab and Radiation for Unresectable Vulvar Squamous Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Vulvar Cancer
• Vulvar Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin	Participants will be given Cisplatin by intravenous infusion at a predetermined dose 1x weekly up to 8 weeks.
DRUG	Pembrolizumab	Participants will be given Pembrolizumab by intravenous infusion at a predetermined dose 1x every 3 weeks up to 36 weeks.
RADIATION	Radiation Therapy	Standard of care radiation therapy 1x daily up to 8 weeks.

Timeline

• Start date: 2020-07-29
• Primary completion: 2026-04-30
• Completion: 2028-01-30
• First posted: 2020-06-12
• Last updated: 2026-03-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study