Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575686
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Epcoritamab and Tazemetostat for the Treatment of Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study of Epcoritamab Plus Tazemetostat for Treatment of RelapsedRefractory Follicular Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 the safety side effects and effectiveness of epcoritamab and tazemetostat in treating patients with grade I-IIIa follicular lymphoma that has come back after a period of improvement relapsed or that has not responded to previous treatment refractory Epcoritamab is a bispecific monoclonal antibody that binds to two different antigens on the surface of cancer cells that may help the bodys immune system attack the cancer and may interfere with the ability of the cancer cells to grow and spread Tazemetostat a EZH2 inhibitor may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving epcoritamab and tazemetostat may be safe tolerable andor effective in treating patients with relapsed or refractory grade I-IIIa follicular lymphoma
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safetytolerability of epcoritamab in combination with tazemetostat in patients with relapsedrefractory follicular lymphoma FL Safety lead-In II To evaluate the anti-tumor activity of epcoritamab in combination with tazemetostat in patients with relapsedrefractory FL by complete response rate Phase II
SECONDARY OBJECTIVES
I To estimate overall response rate ORR duration of response DOR of the combination of epcoritamab and tazemetostat
II To estimate progression-free survival and overall survival of the combination of epcoritamab and tazemetostat
III To assess the toxicities of the combination of epcoritamab and tazemetostat
EXPLORATORY OBJECTIVES
I To characterize the T-cell population balance in patients treated with epcoritamab and tazemetostat in different compartments peripheral blood tumor
II To explore correlation between response and presence of EZH2 mutations III To evaluate minimal residual disease MRD dynamics during treatment and explore the correlation of MRD kinetics with response
OUTLINE
Patients receive tazemetostat orally PO twice daily BID on days 1-28 of each cycle Patients also receive epcoritamab subcutaneously SC on days 1 8 15 and 22 of cycles 2-4 then on day 1 of remaining cycles Cycles repeat every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo collection of blood samples on study and undergo bone marrow biopsy and computed tomography CT or positron emission tomography PETCT throughout the study
After completion of study treatment patients are followed up at 30 and 60 days then for up to 2 years
I To assess the safetytolerability of epcoritamab in combination with tazemetostat in patients with relapsedrefractory follicular lymphoma FL Safety lead-In II To evaluate the anti-tumor activity of epcoritamab in combination with tazemetostat in patients with relapsedrefractory FL by complete response rate Phase II
SECONDARY OBJECTIVES
I To estimate overall response rate ORR duration of response DOR of the combination of epcoritamab and tazemetostat
II To estimate progression-free survival and overall survival of the combination of epcoritamab and tazemetostat
III To assess the toxicities of the combination of epcoritamab and tazemetostat
EXPLORATORY OBJECTIVES
I To characterize the T-cell population balance in patients treated with epcoritamab and tazemetostat in different compartments peripheral blood tumor
II To explore correlation between response and presence of EZH2 mutations III To evaluate minimal residual disease MRD dynamics during treatment and explore the correlation of MRD kinetics with response
OUTLINE
Patients receive tazemetostat orally PO twice daily BID on days 1-28 of each cycle Patients also receive epcoritamab subcutaneously SC on days 1 8 15 and 22 of cycles 2-4 then on day 1 of remaining cycles Cycles repeat every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo collection of blood samples on study and undergo bone marrow biopsy and computed tomography CT or positron emission tomography PETCT throughout the study
After completion of study treatment patients are followed up at 30 and 60 days then 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