B-cell Non-Hodgkin's lymphoma, diffuse large B-cell lymphoma MedDRA version: 21.0 Level: PT Classification code 10003903 Term: B-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10012822 Term: Diffuse large B-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: HLGT Class
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male or female, at least 18 years old 2. (Arms 1, 2, 3, and 4) Diagnosis of DLBCL (de novo or histologically transformed from follicular lymphoma or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report: •DLBCL, NOS •High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 (“double-hit” or “triple-hit”) Note: High-grade B-cell lymphomas NOS or other double-/triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible •FL Grade 3B 3. Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2 except for Arms 6 and 7 where ECOG performance status must be 0-1. 4. Subject must have 1 or more measurable disease sites: •A PET/CT scan demonstrating PET-positive lesion(s) AND •At least 1 measurable nodal lesion (long axis = 1.5cm) or = 1 measurable extra-nodal lesion (long axis = 1.0 cm) on CT scan or MRI Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 394 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Diagnosis of High-grade B-cell lymphomas NOS or other double-/triple-hit lymphomas (with histologies not consistent with DLBCL) 2. Subjects who have had prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study are to characterize the safety, toxicity and tolerability profiles of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL and to determine the recommended dose for further investigation of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL. ;Secondary Objective: The secondary objective of the study is to evaluate the anti-NHL activity of epcoritamab when given in combination with anti-neoplastic agents in subjects with B-cell NHL and to characterize the pharmacokinetics of epcoritamab when given in combination with anti-neoplastic agents in subjects with B-cell NHL.;Primary end point(s): The primary endpoint is DLTs of epcoritamab in combination with anti-neoplastic agents. ;Timepoint(s) of evaluation of this end point: Dose limiting toxicities (DLTs) will be assessed during each dose-escalation cohort. For this study, the DLT evaluation period is defined as the first four weeks, i.e., 28 days after the first administration of epcoritamab. After all subjects on a dose level have completed the DLT evaluation period, all available data (including observations occurring beyond the DLT evaluation period) will be evaluated to make a recommendation for the next dose level. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Best overall response by Lugano 2014 criteria (Appendix E) as assessed by investigator for epcoritamab in combination with other anti-neoplastic agents. •Anti-lymphoma activity of epcoritamab in combination with other anti-neoplastic agents: -Duration of response determined per Lugano 2014 criteria as assessed by investigator -Progression free survival determined per Lugano 2014 criteria as assessed by investigator -Complete response (CR) during the study determined per Lugano 2014 criteria as assessed by investigator -Time to response determined per Lugano 2014 criteria as assessed by investigator -Time to next anti-lymphoma therapy -Minimal residual disease negativity -Overall survival ;Timepoint(s) of evaluation of this end point: These will be assessed throughout the study. | — |
Countries
Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Japan, Korea, Republic of, Netherlands, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed