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

Conditions

• Diffuse Large B-Cell Lymphoma
• Follicular Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone — DRUG
  6 cycles (21-day cycles)
• rituximab and lenalidomide — DRUG
  rituximab 6 cycles and lenalidomide 12 cycles (28-day cycles)
• rituximab and bendamustine — DRUG
  6 cycles (28-day cycles)
• rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin — DRUG
  3 cycles (21-day cycles)
• gemcitabine and oxaliplatin — DRUG
  4 cycles (28-day cycles)
• Epcoritamab — BIOLOGICAL
  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 — DRUG
  6 cycles (21-day cycles)
• Lenalidomide — DRUG
  12 cycles (28-day cycles)
• rituximab, ifosfamide, carboplatin, and etoposide phosphate — DRUG
  3 cycles (21-day cycles)
• Epcoritamab — BIOLOGICAL
  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 — BIOLOGICAL
  Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
• Epcoritamab — BIOLOGICAL
  Every week in cycle 1 and then every 8 weeks for a total of 2 years.
• Epcoritamab — BIOLOGICAL
  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 — BIOLOGICAL
  Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
• Epcoritamab — BIOLOGICAL
  Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
• Epcoritamab — BIOLOGICAL
  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 — DRUG
  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 — BIOLOGICAL
  Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.

Study Details

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.

Key Dates

Start date

Nov 3, 2020

Status verified

Jun 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

543 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1 - Epcoritamab + R-CHOP
  In participants with previously untreated DLBCL.
• Experimental: Arm 2 - Epcoritamab + R2
  In participants with R/R FL.
• Experimental: Arm 3 - Epcoritamab + BR
  In participants with previously untreated FL.
• Experimental: Arm 4 - Epcoritamab + R-DHAX/C
  In participants with R/R DLBCL eligible for ASCT.
• Experimental: Arm 5 - Epcoritamab + GemOx
  In participants with R/R DLBCL ineligible ASCT.
• Experimental: Arm 6 - Epcoritamab + R2
  In participants with previously untreated FL.
• Experimental: Arm 7 - Epcoritamab maintenance
  In participants with FL who achieved a CR or PR after receiving SOC treatment in 1L or 2L.
• Experimental: Arm 8 - Epcoritamab + R mini-CHOP
  In participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline.
• Experimental: Arm 9 - Epcoritamab + Lenalidomide
  In participants with R/R FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy.
• Experimental: Arm 10 - Epcoritamab + R-ICE
  In participants with R/R DLBCL eligible for ASCT.

Primary Outcome Measure

Part 1: Number of Participants With Dose limiting Toxicities (DLTs) [ Time Frame: During the first cycle (Cycle length= 28 days) in each cohort ]

Locations (11)

Find similar trials in Birmingham, AL

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