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 of epcoritamab in combination with anti-neoplastic agents in
adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease
activity will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of NHL. Study
doctors put the participants in groups called treatment arms. The combination of
epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a
different treatment combination depending on eligibility. Approximately 394 adult
participants with NHL will be enrolled in 100 sites globally.
In both the dose escalation and dose expansion arms participants will receive
subcutaneous (SC) epcoritamab in 28-day or 21 day cycles dependent on the arm in
combination with the anti-neoplastic agents described below:
1: Oral lenalidomide in participants with relapsed/refractory (R/R) diffuse large B-cell
lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in participants with with R/R
DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV
doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in participants with
newly diagnosed treatment-naïve DLBCL; 4: Oral CC-99282 in participants with R/R DLBCL;
5: Oral CC-99282 in participants with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in
participants with R/R mantle cell lymphoma (MCL); 6B: Oral ibrutinib, and oral venetoclax
in participants with R/R MCL; 7: Oral ibrutinib, and oral venetoclax in participants with
newly diagnosed treatment-naïve MCL.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked
by medical assessments, blood tests, questionnaires and side effects.