Ignite Creation Date:
2024-05-06 @ 7:56 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02638090
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2015-12-18
Brief Title:
Pembro and Vorinostat for Patients With Stage IV Non-small Cell Lung Cancer NSCLC
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase III Study of Pembrolizumab and Vorinostat in Patients With Immune Therapy Naïve and Immune Therapy Pretreated Stage IV NSCLC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The main purpose of this study is to see whether the combination of two drugs called pembrolizumab and vorinostat can help people with advanced lung cancer Researchers also want to find out if the combination of pembrolizumab and vorinostat is safe and tolerable This study will compare the effects of the combination of two drugs called pembrolizumab and vorinostat with the effects of pembrolizumab alone The US Food and Drug Administration FDA has approved pembrolizumab for use to treat a deadly skin cancer called melanoma and lung cancer and vorinostat to treat some forms of blood and lymph node cancers
Detailed Description:
A Phase IRandomized Phase II clinical trial of pembrolizumab and vorinostat in Eastern Cooperative Oncology Group ECOG 0-1 patients with immune therapy naïve and immune therapy pretreated locally advanced or metastatic NSCLC who have progressed through one prior line of therapy
The begins with a phase I dose escalation utilizing the modified continuous reassessment method OQuigley Pepe Fisher 1990 This would be followed by a phase I expansion at the maximum tolerated dose MTD in 18 NSCLC patients who have been previously treated with anti-PD-1 or anti-PD-L1 therapy In parallel a separate phase II arm will randomize 70 patients to a pembrolizumab alone group and a pembrolizumab plus vorinostat group
The begins with a phase I dose escalation utilizing the modified continuous reassessment method OQuigley Pepe Fisher 1990 This would be followed by a phase I expansion at the maximum tolerated dose MTD in 18 NSCLC patients who have been previously treated with anti-PD-1 or anti-PD-L1 therapy In parallel a separate phase II arm will randomize 70 patients to a pembrolizumab alone group and a pembrolizumab plus vorinostat group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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