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

Condition(s) studied

Investigational drug(s) / intervention(s)

rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone: 6 cycles (21-day cycles)

rituximab and lenalidomide: rituximab 6 cycles and lenalidomide 12 cycles (28-day cycles)

rituximab and bendamustine: 6 cycles (28-day cycles)

rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin: 3 cycles (21-day cycles)

gemcitabine and oxaliplatin: 4 cycles (28-day cycles)

Epcoritamab: Every week in cycle 1-4, every 3 weeks in cycle 5 and 6, followed by every 4 weeks in cycle 7 for a total of 1 year.

rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone: 6 cycles (21-day cycles)

Lenalidomide: 12 cycles (28-day cycles)

rituximab, ifosfamide, carboplatin, and etoposide phosphate: 3 cycles (21-day cycles)

Epcoritamab: Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.

Epcoritamab: Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.

Epcoritamab: Every week in cycle 1 and then every 8 weeks for a total of 2 years.

Epcoritamab: Every week in cycles 1 and 2, then every 3 weeks in cycles 3 to 6 and then every 4 weeks for cycles 7 and 8.

Epcoritamab: Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.

Epcoritamab: Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.

Epcoritamab: Eligible participants will receive subcutaneous (SC) epcoritamab in 28-day cycles. Fixed-treatment epcoritamab will be administered following a 2-Set Up Dosing regimen in Cycle 1. There will be 2 cohorts, 2a and 2b with different dosing schedules. Cohort 2a will be dosed weekly (QW) in Cycles 1-3, once every 2 weeks (Q2W) in Cycles 4-9, and once every 4 weeks (Q4W) in Cycle 10 and beyond for up to 2 years. In cohort 2b, an alternate dosing schedule for epcoritamab will be explored: epcoritamab administered QW for Cycles 1-2 only, then Q4W in Cycle 3 and beyond for up to 2 years.

Rituximab and Lenalidomide: Rituximab 375 milligrams per meter squared (mg/m\^2) will be administered intravenously QW in Cycle 1 and Q4W in Cycles 2-5. Lenalidomide 20 mg will be administered orally daily for 21 days for 12 cycles.

Epcoritamab: Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.

Study 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.

Eligibility

Primary outcome measure(s)

• Part 1: Number of Participants With Dose limiting Toxicities (DLTs) — During the first cycle (Cycle length= 28 days) in each cohort
  DLT events are defined as clinically significant adverse events (AEs) or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications as assessed per Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.
• Part 1 and Part 2 (Arms 1-5, 7 and 10): Number of Participants With Adverse Events (AEs) — 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)
  An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign. (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
• Part 2 (Except Arm 7): Overall Response Rate (ORR) — Up to 3 years
  ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria.

Trial sites (57)

+ 17 more sites — see the full list on the official registry below.

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