Status:
RECRUITING
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
Lead Sponsor:
Genmab
Collaborating Sponsors:
AbbVie
Conditions:
Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability o...
Eligibility Criteria
Inclusion
- Diagnosis of:
- \-- Diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma (FL) 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, not otherwise specified (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.
- Follicular lymphoma (FL) Grade 3B. OR
- FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR
- Mantle cell lymphoma (MCL) with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2, except for Arm 6A where ECOG performance status must be 0-1.
- Must have 1 or more measurable disease sites:
- A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND
- At least 1 measurable nodal lesion (long axis \> 1.5 cm) or \>= 1 measurable extra-nodal lesion (long axis \> 1.0 cm) on CT scan or magnetic resonance imaging (MRI).
Exclusion
- Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.
- Toxicities from prior anticancer therapy that have not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia. Other eligibility criteria (e.g., laboratory, cardiac criteria) must also be met.
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2032
Estimated Enrollment :
496 Patients enrolled
Trial Details
Trial ID
NCT05283720
Start Date
June 14 2022
End Date
November 1 2032
Last Update
January 7 2026
Active Locations (74)
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1
The University of Arizona Cancer Center - North Campus /ID# 242219
Tucson, Arizona, United States, 85719
2
Yale University School of Medicine /ID# 242089
New Haven, Connecticut, United States, 06510
3
Christiana Care Health Service /ID# 242301
Newark, Delaware, United States, 19713
4
Tampa General Hospital /ID# 246748
Tampa, Florida, United States, 33606