Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636734
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Lovastatin and Pembrolizumab for the Treatment of Patients with Recurrent or Metastatic Head and Neck Cancer LAPP Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Trial of Lovastatin and Pembrolizumab in Patients with RM HNSCC LAPP
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests how well lovastatin and pembrolizumab work in treating patients with head and neck cancer that has come back after a period of improvement recurrent or that has spread from where it first started primary site to other places in the body metastatic Lovastatin is a drug used to lower the amount of cholesterol in the blood and may also cause tumor cell death In addition studies have shown that lovastatin may make the tumor cells more sensitive to immunotherapy Immunotherapy with monoclonal antibodies such as pembrolizumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Giving lovastatin and pembrolizumab may kill more tumor cells in patients with recurrent or metastatic head and neck cancer
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate anti-tumor activity of the combination of pembrolizumab and lovastatin by assessing the objective response rate ORR by Response Evaluation Criteria in Solid Tumors RECIST 11
SECONDARY OBJECTIVE
I To evaluate the anti-tumor activity of the combination of by assessing progression-free survival PFS and overall survival OS
TERTIARYEXPLORATORY OBJECTIVES
I To assess the effects of the combination of lovastatin pembrolizumab on immune cells in blood
II To assess the association between efficacy measures and expression in tumors
III To assess the association between anti-tumor activity and immune cells in the blood
OUTLINE
Patients receive lovastatin orally PO once daily QD and pembrolizumab intravenously IV over 60 minutes on day 1 of each cycle Cycles repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity Patients also undergo blood sample collection and computed tomography CT magnetic resonance imaging MRI or positron emission tomography PETCT throughout the study
After completion of study treatment patients are followed for up to 2 years
I To evaluate anti-tumor activity of the combination of pembrolizumab and lovastatin by assessing the objective response rate ORR by Response Evaluation Criteria in Solid Tumors RECIST 11
SECONDARY OBJECTIVE
I To evaluate the anti-tumor activity of the combination of by assessing progression-free survival PFS and overall survival OS
TERTIARYEXPLORATORY OBJECTIVES
I To assess the effects of the combination of lovastatin pembrolizumab on immune cells in blood
II To assess the association between efficacy measures and expression in tumors
III To assess the association between anti-tumor activity and immune cells in the blood
OUTLINE
Patients receive lovastatin orally PO once daily QD and pembrolizumab intravenously IV over 60 minutes on day 1 of each cycle Cycles repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity Patients also undergo blood sample collection and computed tomography CT magnetic resonance imaging MRI or positron emission tomography PETCT throughout the study
After completion of study treatment patients are followed for up to 2 years
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