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

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.

Conditions

• Diffuse Large B-Cell Lymphoma
• Follicular Lymphoma

Interventions

BIOLOGICAL

Epcoritamab

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

DRUG

rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone

6 cycles (21-day cycles)

DRUG

rituximab and lenalidomide

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

DRUG

rituximab and bendamustine

6 cycles (28-day cycles)

DRUG

rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin

3 cycles (21-day cycles)

DRUG

gemcitabine and oxaliplatin

4 cycles (28-day cycles)

BIOLOGICAL

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.

DRUG

rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone

6 cycles (21-day cycles)

DRUG

Lenalidomide

12 cycles (28-day cycles)

DRUG

rituximab, ifosfamide, carboplatin, and etoposide phosphate

3 cycles (21-day cycles)

BIOLOGICAL

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.

BIOLOGICAL

Epcoritamab

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

BIOLOGICAL

Epcoritamab

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

BIOLOGICAL

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.

BIOLOGICAL

Epcoritamab

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

BIOLOGICAL

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.

DRUG

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.

BIOLOGICAL

Epcoritamab

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

Sponsors & Collaborators

• AbbVie

  collaborator INDUSTRY

• Genmab

  lead INDUSTRY

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-03

Primary Completion

2027-09-30

Completion

2027-09-30

FDA Drug

Yes

Countries

• United States
• Australia
• Belgium
• Czechia
• Denmark
• Finland
• France
• Italy
• Netherlands
• Norway
• Spain
• Sweden
• United Kingdom

Study Locations