NCT03512834

Paclitaxel-Avelumab for Angiosarcoma

Phase II Trial, Multicenter, First Line Paclitaxel-Avelumab Treatment for Inoperable Angiosarcoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Sung Yong Oh · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy of Avelumab when given in combination with paclitaxel as a first line treatment for the patients with inoperable angiosarcoma.

Detailed description

Angiosarcomas are very rare tumors (incidence \< 1/100.000/year) of vascular or lymphatic origin characterized by a clinical heterogeneity in terms of presentation and behavior.In several prospective and retrospective studies, weekly paclitaxel showed promising activity in patients with advanced or metastatic angiosarcoma. Given the important role of PD-L1 in the suppression of T-cell responses, and the mode of action of avelumab which blocks the interaction between PD-L1 and its receptors, avelumab is being developed as a potential therapy for subjects with various tumors. In prior study cutaneous angiosarcoma patients with a high infiltration of PD-1-positive cells with tumor site PD-L1 expression were more likely to have favorable survival. Therefore, antitumor activity of Avelumab as inhibitor of PD-1/PDL-1 interaction with Paclitaxel, standard chemotherapy, might have more therapeutic improvement.

Conditions

• Angiosarcoma Metastatic

Interventions

Type	Name	Description
DRUG	Avelumab	Avelumab 10mg/kg, administered via I.V infusion over 1hour, every 2weeks until disease progression or unacceptable toxicity
DRUG	Paclitaxel	Paclitaxel 80mg/m2 D1,8 and 15 , administered via I.V infusion, every 4 weeks.

Timeline

• Start date: 2018-06-01
• Primary completion: 2022-11-01
• Completion: 2023-05-01
• First posted: 2018-05-01
• Last updated: 2018-07-11

Locations

1 site across 1 country: South Korea