臨床研究等提出・公開システム

The phase II study of pembrolizumab plus lenvatinib for patients with unresectable cutaneous angiosarcoma (Pembro-Lenva for cAS / PLAS trial)

NCCH2213 trial (PLAS trial)

Ogata Dai

National Cancer Center Hospital

5-1-1 Tsukiji, Chuo-ku, Tokyo 1040045, Japan

ncch2213_office@ml.res.ncc.go.jp

NCCH2213 Clinical Trial Coordinating Office

National Cancer Center Hospital

5-1-1 Tsukiji, Chuo-ku, Tokyo 1040045, Japan

+81-3-3542-2511

ncch2213_office@ml.res.ncc.go.jp

Recruiting

Dec. 01, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

unresectable cutaneous angiosarcoma

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).

cutaneous angiosarcoma, angiosarcoma

pembrolizumab, immune checkpoint inhibitor, lenvatinib, molecularly targeted drug, combination therapy

objective response rate (centrally assessed)

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

+81-3-3542-2511

July. 10, 2024

No

none