unresectable cutaneous angiosarcoma cutaneous angiosarcoma, angiosarcoma
Conditions
Interventions
Each course is set at 21 days. Pembrolizumab 200 mg will be administered intra-venously on day 1 of each course (every 21 days). Lenvatinib 20 mg will be taken orally on days 1 to 21 (daily).
pembrolizumab, immune checkpoint inhibitor, lenvatinib, molecularly targeted drug, combination therapy
Sponsors
Ogata Dai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically diagnosed with cutaneous angiosarcoma, and having an unresectable primary or metastatic lesion 2)Having at least one measurable lesion on the body surface that was confirmed by contrast-enhanced CT/MRI or visual inspection within 14 days before enrollment 3)18 to 85 years old at enrollment 4)With stable blood pressure at 150/90 mmHg or lower within 7 days before enrollment 5)With healed wounds (if any) at enrollment 6)Cooperative with highly effective contraception methods 7)Having given written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2, other agents targeting co-inhibitory T-cell receptors, or angiogenesis inhibitors 2)Patients who received chemotherapy or radiotherapy within 28 days before enrollment, or who have not recovered from those toxicities 3)Patients who used other investigational drugs or investigational medical devices within 28 days before enrollment 4)Patients who received live or live attenuated vaccines within 30 days before enrollment 5)Patients with other malignant tumors progressive or requiring aggressive treatment within the past 3 years 6)Patients with active CNS metastasis or carcinomatous meningitis 7)Patients with active autoimmune disease within 2 years before enrollment 8)Patients with clinically significant cardiovascular diseases at NYHA class III or IV within 12 months before enrollment 9)Patients with encasement or invasion of a major blood vessel, or intratumoral cavitation that was diagnosed radiographically within 14 days before enrollment 10)Patients with active infections, gastrointestinal ulcer of Grade 3-4 or fistula, or conditions that might affect gastrointestinal absorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate (centrally assessed) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate (investigator assessed), progression-free survival, overall survival, disease control rate, incidence of adverse events, incidence of adverse (drug) reactions, incidence of serious adverse events/reactions, duration of response, and time to response | — |
Contacts
Public ContactNCCH2213 Clinical Trial Coordinating Office
National Cancer Center Hospital
Outcome results
None listed