Cutaneous angiosarcoma is a rare cancer for which effective treatment has not been developed sufficiently. Still, because it often occurs in elderly people, the number of patients is increasing due to the aging population. Cutaneous angiosarcoma is difficult to completely remove by surgery, and recurrence and metastasis after surgery are not uncommon. Therefore, chemotherapy, radiation therapy, and a combination of these are currently widely used as treatments. Traditionally, the anticancer drug used for cutaneous angiosarcoma was mainly doxorubicin. In recent years, it has been reported that cancer shrank in 18% of patients after two months of paclitaxel administration in a clinical trial. Therefore, paclitaxel has become more commonly used for cutaneous angiosarcoma. Other options include anthracycline anticancer drugs and gemcitabine. However, even with these anticancer drugs (and radiation therapy), cutaneous angiosarcoma progresses quickly, and some reports have said that the 5-year survival rate is 9%. This study is planned to develop a safer and more effective treatment for cutaneous angiosarcoma and will include 38 participants. In this study, eligible participants will receive combination chemotherapy with 200 mg of pembrolizumab (injection liquid, once every 3 weeks) and 20 mg of lenvatinib (capsule, once daily) for up to approximately two years as protocol treatment unless the criteria for termination meet. Before, during, and after the protocol treatment, participants will undergo many examinations and evaluations, including blood tests, urine tests, and imaging tests (e.g., x-ray, CT scan, or MRI) to assess the safety and efficacy of the protocol treatment.
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Overall Response Rate (ORR) by central review
Timeframe: Overall Response is assessed every 6 weeks until 24 weeks after initiation of protocol treatment and every 12 weeks after 25 weeks until PD confirmation or post-study treatment initiation, an estimated average of 1 year.