This phase II trial compares epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy. Epcoritamab is a bispecific antibody. It works by simultaneously attaching to a molecule called CD20 on cancerous B-cells and a molecule called CD3 on effector T-cells, which are a type of immune cell. When epcoritamab binds to CD20 and CD3, it brings the two cells together and activates the T-cells to kill the cancerous B-cells. Epcoritamab may increase a patient's chances of achieving complete remission after CD19-directed CAR-T therapy, compared to standard observation.
Men and women >= 18 years of age
Documented histological confirmation of diffuse large b-cell lymphoma not otherwise specified [DLBCL NOS], primary mediastinal large b-cell lymphoma (LBCL), or transformations of indolent B-cell lymphomas, according to the 5th edition of World Health Organization (WHO) classification of lymphoid neoplasms, with CD20 positivity as determined by assessment of tumor cells =< 6 months prior to registration pre- CAR-T biopsy specimen by immunohistochemistry or flow cytometry
Patients treated with the commercially available CD19-directed CAR-T products axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel), and who have a partial response at day 30 +/- 7 days PET- CT assessment based on Lugano criteria (Deauville score of 4 or 5)
Documented measurable disease
Patients post CAR-T who have bulky disease defined as a disease focus >= 7.5cm in diameter at day 30 +/- 7 days PET-CT assessment
Patients post CAR-T who have progressive disease, stable disease or complete response at day 30 +/- 7 days PET-CT assessment based on Lugano criteria
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effect on the developing fetus and newborn are unknown
Pregnant persons
Parallel
Biopsy
Procedure/SurgeryUndergo biopsy
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Computed Tomography
Procedure/SurgeryUndergo PET/CT and/or CT
Epcoritamab
Biological/VaccineGiven SC
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Patient Observation
Other interventionUndergo observation
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Objective status of complete response (CR)
CR will be assessed using Lugano 2014 criteria. Complete response rate is defined as the number of patients who achieve objective status of CR divided by the total number patients in each arm. Primary analysis population will be used for this endpoint. The proportion of CR rate in each arm with corresponding confidence interval and p-value comparing the CR rate will be reported.
Progression free survival
Disease progression will be defined by Lugano 2014 criteria. Primary analysis population will be used for this endpoint. The distribution of progression free survival will be estimated using the method of Kaplan-Meier. Progression free survival will be compared between the 2 treatment arms using the log-rank test. The median progression free survival and corresponding 95% confidence intervals will be reported.
Event free survival
Disease progression will be defined by Lugano 2014 criteria. Primary analysis population will be used for this endpoint. The distribution of event free survival will be estimated using the method of Kaplan-Meier. Event free survival will be compared between the 2 treatment arms using the log-rank test. The median event free survival and corresponding 95% confidence intervals will be reported.
Overall survival
Primary analysis population will be used for this endpoint. The distribution of overall survival will be estimated using the method of Kaplan-Meier. Overall survival will be compared between the 2 treatment arms using the log-rank test. The median overall survival and corresponding 95% confidence intervals will be reported.
Duration of response
Disease progression will be defined by Lugano 2014 criteria. Primary analysis population achieving response of CR or PR will be used for this endpoint. The distribution of duration of response will be estimated using the method of Kaplan-Meier. Duration of response will be compared between the 2 treatment arms using the log-rank test. The median duration of response and corresponding 95% confidence intervals will be reported.
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Academic and Community Cancer Research United
Lead sponsor
National Cancer Institute (NCI)
Collaborator
