Ignite Creation Date:
2024-05-06 @ 7:14 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02497508
Status:
COMPLETED
Last Update Posted:
2017-09-14
First Post:
2015-07-06
Brief Title:
Nivolumab in Patients With Recurrent Malignant Mesothelioma
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
A Single Arm Phase II Study of Nivolumab in Patients With Recurrent Malignant Pleural Mesothelioma Interim Biopsy Analysis to Determine Efficacy Acronym NivoMes Study
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
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:
NivoMes
Brief Summary:
This is a prospective single arm phase II trial in previously treated patients with MPM who are considered candidates for immunotherapy and repeat thoracoscopiestransthoracic biopsies Nivolumab will be administered 3 mgkg q2 weeks by intravenous injection
The administration of nivolumab as monotherapy will improve DCR form 20 to 40 at 12 weeks when compared to DCR of patients treated with best supportive care based on historical controls
The administration of nivolumab as monotherapy will improve DCR form 20 to 40 at 12 weeks when compared to DCR of patients treated with best supportive care based on historical controls
Detailed Description:
Patients will undergo pre- and post-treatment thoracoscopiesbiopsies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None