Active — Not RecruitingPhase 1/2

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

United States543 participantsStarted 2020-11-03

Plain-language summary

The purpose of this trial is to measure the safety and effectiveness of epcoritamab (EPKINLY™), either by itself or together with other therapies, when treating participants with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to identify the most appropriate dose of epcoritamab, and the aim of the second part of the trial is to assess the selected epcoritamab dose in a larger group of participants with B-NHL. All participants in this trial will receive either epcoritamab alone, or epcoritamab combined with another standard treatment regimen, with a total of 10 different treatment arms being studied. Trial details include: * The treatment duration for each participant depends upon which arm of treatment they are assigned to. * The visit frequency for each participant depends upon which arm of treatment they are assigned to, but will be weekly to start for all participants, then will decrease to either: every 2 weeks, or every 3 weeks, or every 4 weeks, or every 8 weeks. * All participants will receive active drug; no one will be given placebo. Participants who receive treatment with epcoritamab will have it injected right under the skin. Participants will receive a different regimen of epcoritamab depending upon which arm of treatment they are assigned. Participants who receive standard treatments will have intravenous (IV) infusions and/or oral administration of those treatments. Participants will receive a different standard treatment regimen depending upon which arm of treatment they are assigned.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Measurable disease defined as ≥1 measurable nodal lesion (long axis \>1.5 cm and short axis \>1.0 cm) or ≥1 measurable extra-nodal lesion (long axis \>1.0 cm) on computed tomography (CT) or magnetic resonance imaging (MRI). Applies to all arms except arm 7.
✓. Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2
✓. Acceptable organ function at screening
✓. CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy
✓. If of childbearing potential participant must practicing a highly effective method of birth control
✓. A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control

Exclusion criteria

✕. Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
✕. Any prior treatment with a bispecific antibody targeting CD3 and CD20.
✕

What they're measuring

Part 1: Number of Participants With Dose limiting Toxicities (DLTs)

Timeframe: During the first cycle (Cycle length= 28 days) in each cohort

Part 1 and Part 2 (Arms 1-5, 7 and 10): Number of Participants With Adverse Events (AEs)

Timeframe: From first dose of drug until either 60 days after last dose, date participant withdraws consent, date participant starts a new systemic anticancer therapy, or date participant dies, whichever occurs first (up to approximately 3 years)

Part 2 (Except Arm 7): Overall Response Rate (ORR)

Timeframe: Up to 3 years

Trial details

NCT IDNCT04663347

SponsorGenmab

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09-30

View on ClinicalTrials.gov More Diffuse Large B-Cell Lymphoma trials