Epcoritamab and Tazemetostat for the Treatment of Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
NCT Number: NCT06575686
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Recurrent Grade 1 Follicular Lymphoma|Recurrent Grade 2 Follicular Lymphoma|Recurrent Grade 3a Follicular Lymphoma|Refractory Grade 1 Follicular Lymphoma|Refractory Grade 2 Follicular Lymphoma|Refractory Grade 3a Follicular Lymphoma
Interventions: PROCEDURE: Biospecimen Collection|PROCEDURE: Bone Marrow Biopsy|PROCEDURE: Computed Tomography|BIOLOGICAL: Epcoritamab|PROCEDURE: Positron Emission Tomography|DRUG: Tazemetostat
Sponsor: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-23
Completion Date: 2027-06-15
Locations: City of Hope Medical Center, Duarte, California, 91010, United States|City of Hope at Irvine Lennar, Irvine, California, 92618, United States

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 body's 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 and/or effective in treating patients with relapsed or refractory grade I-IIIa follicular lymphoma.

Primary Outcome Measures: Incidence of unacceptable adverse events (Safety lead-in), Observed toxicities will be summarized by type, severity, and attribution. (each cycle is 28 days), up to first 2 cycles of study treatment|Complete response (CR) rate, CR rate will be defined as a best response of CR according to Lugano criteria before any documented disease progression or any subsequent non-Hodgkin lymphoma (NHL) treatment. CR rate will be estimated along with the 95% exact binomial confidence interval., Up to 3 years
Secondary Outcome Measures: Overall response rate (ORR), ORR will be defined as a best response of CR or partial response (PR) according to Lugano 2016 guidelines on study before any documented disease progression or any subsequent NHL treatment. ORR will be estimated along with the 95% exact binomial confidence interval., Up to 3 years|Duration of response (DOR), DOR will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error, and 95% confidence interval will be constructed based on log-log transformation. Median DOR will be estimated when possible., From CR or PR to disease progression/relapse or death, up to 3 years|Progression-free survival (PFS), PFS will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error, and 95% confidence interval will be constructed based on log-log transformation. Median PFS will be estimated when possible., From start of protocol treatment to disease relapse/progression or death, up to 3 years|Overall survival (OS), OS will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error, and 95% confidence interval will be constructed based on log-log transformation. Median OS will be estimated when possible., From start of protocol treatment to death, up to 3 years|Incidence of adverse events, Adverse events will be evaluated and graded using Common Terminology Criteria for Adverse Events version 5.0. Cytokine release syndrome and or immune effector cell associated neurotoxicity syndrome will be evaluated using American Society for Transplantation and Cellular Therapy Consensus grading criteria. Observed toxicities will be summarized by type, severity, and attribution., Up to 60 days after last dose of study drug