Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318286
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-27
Brief Title:
Study of Pembrolizumab Plus Chemotherapy With Lenvatinib for Malignant Pleural Mesothelioma
Sponsor:
Hyogo Medical University
Organization:
Hyogo Medical University
Study Overview
Official Title:
First-line Pembrolizumab Plus Platinum Doublet Chemotherapy With Lenvatinib in Unresectable Malignant Pleural MesotheliomaMulti-Institutional Single-Arm Phase 2 Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
PENINSULA
Brief Summary:
In this Phase-II study the investigators will investigate the efficacy and safety of lenvatinib in combination with pembrolizumab and chemotherapy in patients with malignant pleural mesothelioma
Detailed Description:
This is a single-arm open-label study to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab and chemotherapy in patients with malignant pleural mesothelioma The study will consist of a screening phase a treatment phase and a follow-up phase Patients who meet the Inclusion Criteria do not meet the Exclusion Criteria and are judged by the investigator to be eligible for this clinical trial will be included Subjects who meet all of the criteria listed in Criteria for Administration of Investigational Drugs may continue to receive the investigational drug If a subject receiving investigational drugs meets any of the criteria listed in Discontinuation Criteria of Investigational Drugs the subject will be evaluated at the end of the treatment phase at the time of discontinuation and moved to the post-observation phase
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None