A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Launched by GENMAB · Jul 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment for adult patients with diffuse large B-cell lymphoma (DLBCL), a type of aggressive cancer affecting immune cells. Researchers want to see how well the investigational drug epcoritamab, given through a subcutaneous injection (a shot under the skin), works when paired with lenalidomide (a pill) compared to the standard treatment of rituximab, gemcitabine, and oxaliplatin, all given through an intravenous (IV) infusion. The trial aims to understand the safety and effectiveness of these treatments in patients who have already experienced a relapse or whose cancer did not respond to previous therapies.

To be eligible for the study, participants must have a confirmed diagnosis of DLBCL and have had at least one prior treatment for their condition. Additionally, they should not have certain complications, such as active central nervous system involvement by cancer or a history of specific previous treatments. Participants will be divided into two groups; one will receive the new combination therapy for up to 12 cycles, while the other will undergo the standard IV treatment for up to 4 cycles. Throughout the trial, participants will have regular check-ups to monitor their health, side effects, and how well the treatment is working. It's important to note that joining this trial may involve more visits and assessments than standard care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Eastern Cooperative Oncology Group Performance status score of 0 to 2.
• • Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documented in the most recent and representative pathology report, inclusive of the following according to the World Health Organization (WHO) 2022 as per the protocol.
• • Must have relapsed or refractory (R/R) disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis.
• * Participant must meet at least 1 of the following criteria:
• • Failed prior autologous stem cell transplant (ASCT), defined as relapsed after ASCT or been refractory to high-dose therapy (HDT)-ASCT.
• • Not be considered a candidate for ASCT due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT.
• * Be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) meeting at least 1 of the following criteria:
• • Unable to receive CAR-T therapy due to fitness and/or comorbidity.
• • Lymphocyte apheresis failure.
• • Unwilling to receive CAR-T therapy.
• • Unable to receive CAR-T therapy due to financial, geographic, insurance, access, and/or manufacturing constraints.
• • Relapsed/progressed after having achieved at least a Partial Response (PR) or Complete Response (CR) while on prior CAR-T therapy.
• • Must have measurable disease.
• • Life expectancy \> 3 months on standard of care treatment at the time of enrolling in the study
• Exclusion Criteria:
• • Current evidence of primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening.
• • History of prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with rituximab plus gemcitabine and oxaliplatin (R-GemOx) or gemcitabine and oxaliplatin (GemOx).
• • Documented refractoriness to lenalidomide.