Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT03512834
Status:
UNKNOWN
Last Update Posted:
2018-07-11
First Post:
2018-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paclitaxel-Avelumab for Angiosarcoma
Sponsor:
Sung Yong Oh
Organization:
Study Overview
Official Title:
Phase II Trial, Multicenter, First Line Paclitaxel-Avelumab Treatment for Inoperable Angiosarcoma
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASAP
Brief 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.
Therefore, antitumor activity of Avelumab as inhibitor of PD-1/PDL-1 interaction with Paclitaxel, standard chemotherapy, might have more therapeutic improvement.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: