Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06242834
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2024-01-29
Brief Title:
Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-cell Therapy in Patients With Aggressive B-Cell Non-Hodgkins Lymphoma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase II Single Arm Open Label Study of the Combination of Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-Cell Therapy in Patients With Aggressive B-Cell Non-Hodgkins Lymphoma
Status:
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 pembrolizumab and tazemetostat work to treat patients who have received autologous stem cell transplantation ASCT or chimeric antigen receptor CAR T cell therapy for aggressive non hodgkins lymphoma A monoclonal antibody such as pembrolizumab is a type of protein that can bind to certain targets in the body such as molecules that cause the body to make an immune response antigens Tazemetostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving pembrolizumab and tazemetostat may work better to treat patients who have received ASCT or CAR-T cell therapy for aggressive non hodgkins lymphoma
Detailed Description:
PRIMARY OBJECTIVE
I To assess the event-free survival EFS for the combination of pembrolizumab and tazemetostat as maintenance for 12 months in patients with aggressive B-cell Non- Hodgkins Lymphoma following ASCT or CAR T-cell therapy
SECONDARY OBJECTIVES
I To assess the progression-free survival PFS for the combination of pembrolizumab and tazemetostat as maintenance for 12 months in patients with aggressive B-cell Non-Hodgkins Lymphoma following ASCT or CAR T-cell therapy
II To assess the overall survival OS for the combination of pembrolizumab and tazemetostat as maintenance for 12 months in patients with aggressive B-cell Non-Hodgkins Lymphoma following ASCT or CAR T-cell therapy
III To evaluate the safety and toxicity of the combination of pembrolizumab and tazemetostat as maintenance therapy for 12 months following ASCT or CAR T cell therapy
IV To determine the objective response rate ORR complete response CR rate and partial response PR rate in patients receiving CAR T-cell therapy during maintenance phase as assessed by Lugano Criteria
EXPLORATORY OBJECTIVES
I To assess the change in immune cell subsets and cytokines measured by flow and proteomics with pembrolizumab alone and in combination with tazemetostat
II To determine survival outcomes event free survival EFS PFS and OS by type of treatment and line of therapy ASCT CAR T-cell therapy in second and third line
OUTLINE
Starting on day 14 after standard of care ASCT or CAR-T cell treatment patients receive pembrolizumab intravenously IV on day 1 of each cycle Starting cycle 2 patients receive tazemetostat orally PO twice dailyBID on days 1-21 of each cycle Cycles repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity Patients undergo echocardiography during screening computed tomography CT scan positron emission tomography PET scan and blood sample collection throughout the study
After completion of study treatment patients are followed up within 90 days and periodically for up to 18 months
I To assess the event-free survival EFS for the combination of pembrolizumab and tazemetostat as maintenance for 12 months in patients with aggressive B-cell Non- Hodgkins Lymphoma following ASCT or CAR T-cell therapy
SECONDARY OBJECTIVES
I To assess the progression-free survival PFS for the combination of pembrolizumab and tazemetostat as maintenance for 12 months in patients with aggressive B-cell Non-Hodgkins Lymphoma following ASCT or CAR T-cell therapy
II To assess the overall survival OS for the combination of pembrolizumab and tazemetostat as maintenance for 12 months in patients with aggressive B-cell Non-Hodgkins Lymphoma following ASCT or CAR T-cell therapy
III To evaluate the safety and toxicity of the combination of pembrolizumab and tazemetostat as maintenance therapy for 12 months following ASCT or CAR T cell therapy
IV To determine the objective response rate ORR complete response CR rate and partial response PR rate in patients receiving CAR T-cell therapy during maintenance phase as assessed by Lugano Criteria
EXPLORATORY OBJECTIVES
I To assess the change in immune cell subsets and cytokines measured by flow and proteomics with pembrolizumab alone and in combination with tazemetostat
II To determine survival outcomes event free survival EFS PFS and OS by type of treatment and line of therapy ASCT CAR T-cell therapy in second and third line
OUTLINE
Starting on day 14 after standard of care ASCT or CAR-T cell treatment patients receive pembrolizumab intravenously IV on day 1 of each cycle Starting cycle 2 patients receive tazemetostat orally PO twice dailyBID on days 1-21 of each cycle Cycles repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity Patients undergo echocardiography during screening computed tomography CT scan positron emission tomography PET scan and blood sample collection throughout the study
After completion of study treatment patients are followed up within 90 days and periodically for up to 18 months
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-00285 | REGISTRY | None | None |
| STU00220351 | None | None | None |
| NU 23H05 | OTHER | None | None |
| P30CA060553 | NIH | Northwestern University | httpsreporternihgovquickSearchP30CA060553 |