Actively Recruiting
Pembrolizumab Plus Lenvatinib in Unresectable Cutaneous Angiosarcoma Patients
Led by National Cancer Center, Japan · Updated on 2025-11-18
38
Participants Needed
5
Research Sites
260 weeks
Total Duration
On this page
Sponsors
N
National Cancer Center, Japan
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pembrolizumab Plus Lenvatinib in Unresectable Cutaneous Angiosarcoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of cutaneous angiosarcoma
- Disease that cannot be removed surgically (unresectable primary or metastatic)
- No spinal metastases needing radiotherapy or surgery
- No pericardial, pleural effusion, or ascites requiring treatment
- Age between 18 and 85 years at enrollment
- ECOG performance status score of 0 or 1 within 14 days before enrollment
- Recent contrast-enhanced CT or MRI within 14 days before enrollment, or at least one measurable lesion visible on the body surface
- Belong to Cohort A (no prior therapy) or Cohort B (previously treated)
- Controlled blood pressure (≤150/90 mmHg) with or without up to two antihypertensive medications and no medication changes within 7 days before enrollment
- Healed wounds from surgery or trauma at enrollment
- No major surgery within 21 days prior to first study dose, with adequate wound healing
- Laboratory tests within 14 days before enrollment meeting specified blood counts and organ function levels
- Male participants agree to use highly effective contraception and avoid sperm donation during treatment and 120 days after last dose
- Female participants not pregnant or breastfeeding and agree to use contraception or abstain from heterosexual intercourse during treatment and post-treatment periods
- At least 28 days since last chemotherapy and recovery from related toxicities except alopecia and mild blood toxicity
- Provided written informed consent
You will not qualify if you...
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other co-inhibitory T-cell receptor agents
- Previous treatment with lenvatinib or other angiogenesis inhibitors
- Likely curable with chemoradiotherapy per physician judgment
- Radiation therapy within 14 days before enrollment or radiation-related toxicities at enrollment
- Positive for HIV antibody, HBs antigen, or HCV antibody
- HBV-DNA positive despite negative HBs antigen and positive HBV antibodies
- Received live or live attenuated vaccines within 30 days before enrollment
- Use of other investigational drugs or devices within 28 days before enrollment
- Immunocompromised state or recent long-term steroid or immunosuppressive therapy
- Other malignancies requiring aggressive treatment within past 3 years
- Active central nervous system metastases or carcinomatous meningitis
- Severe hypersensitivity to pembrolizumab or lenvatinib additives
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of interstitial lung disease or pneumonitis requiring steroids
- Active infections needing systemic treatment at enrollment
- Grade 3 or higher fistula at enrollment
- Gastrointestinal malabsorption or conditions affecting lenvatinib absorption
- Recent acute coronary events or clinically significant cardiovascular disease
- Left ventricular ejection fraction below 50%
- Complications requiring hospitalization
- Radiographic evidence of major blood vessel invasion or tumor cavitation
- QTcF interval prolongation beyond 480 msec
- Active hemoptysis within 21 days before enrollment
- Psychotic, psychiatric, or substance use disorders interfering with daily life
- History of allogeneic transplantation
AI-Screening
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Trial Site Locations
Total: 5 locations
1
National Cancer Center Hospital East
Kashiwa, Japan
Actively Recruiting
2
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Japan
Actively Recruiting
3
Nagoya City University Hospital
Nagoya, Japan
Actively Recruiting
4
Keio University Hospital
Tokyo, Japan
Actively Recruiting
5
National Cancer Center Hospital
Tokyo, Japan
Actively Recruiting
Research Team
D
Dai Ogata, M.D., Ph.D.
CONTACT
E
Eiji Nakano, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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