Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04710628
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2020-12-03
Brief Title:
Combination of Pembrolizumab and Lenvatinib in Pre-treated Thymic CArcinoma paTIents
Sponsor:
MedSIR
Organization:
MedSIR
Study Overview
Official Title:
A Multicentric Open-Label Single Arm Phase II Study To Evaluate The Efficacy And Safety Of The Combination Of PEmbrolizumab And Lenvatinib In Pre-Treated Thymic Carcinoma PaTIents PECATI
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
PECATI
Brief Summary:
This is a multicentric open-label single arm phase II study to evaluate the efficacy and safety of the combination of pembrolizumab and lenvatinib in pre-treated thymic carcinoma patients who have progressed after at least one line of platinum-based chemotherapy for advanced disease without having received any previous immunotherapy previous bevacizumab allowed but not sunitinib and not amenable to curative-intent radical surgery andor radiotherapy regardless of PD-L1 status
Detailed Description:
Men and women aged 18 years old diagnosed with B3-thymoma or metastatic thymic carcinoma who have progressed after at least one line of platinum-based chemotherapy for advanced disease without having received any previous immunotherapy previous bevacizumab allowed but not sunitinib and not amenable to curative-intent radical surgery andor radiotherapy regardless of PD- L1 status Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors RECIST version v11 criteria Patients are not eligible if they are candidates for a local treatment with a curative intention Patients must present Eastern Cooperative Oncology Group ECOG Performance Status 0-1 and with adequate organ function
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?:
False
Is an FDA AA801 Violation?:
None