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Pembrolizumab Plus Lenvatinib in Unresectable Cutaneous Angiosarcoma Patients

NCT06673628 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

  • Angiosarcoma of Skin
  • Angiosarcoma Metastatic

Interventions

DRUG

Pembrolizumab plus Lenvatinib

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2028-11-30
Completion
2029-11-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06673628 on ClinicalTrials.gov