At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed cutaneous angiosarcoma
- ✓Unresectable primary or metastatic disease
- ✓Age 18-85 years
- ✓ECOG performance status 0 or 1
- ✕Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or other co-inhibitory T-cell receptor agents (CTLA-4, OX-40, CD137)
- ✕Prior lenvatinib or other angiogenesis inhibitors for any cancer
- ✕Likely to be cured with chemoradiotherapy per treating physician discretion
- ✕Radiation therapy within 14 days prior or with radiation therapy-related toxicities at enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Phase II Study of Pembrolizumab Plus Lenvatinib in Patients With Unresectable Cutaneous Angiosarcoma
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab plus Lenvatinib for Angiosarcoma of Skin and Angiosarcoma Metastatic. Currently recruiting, targeting 38 participants across 6 sites.
Signals
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
Interventions
One course is fixed at 21 days, and the length of course is not extended or shortened. Participants receive 200 mg of pembrolizumab injection intravenously over approximately 30 minutes on day 1 of each course, and take 20 mg of lenvatinib capsules orally once daily, preferably at the same time each day. Treatment with pembrolizumab and lenvatinib will be continued for up to 35 courses unless the criteria for termination of protocol treatment are met.