Outpatient Epcoritamab as 2L in NTE R/R DLBCL

Conditions

• Refractory Large B-cell Lymphoma
• Relapsed Large B-cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Epcoritamab — DRUG
  Bispecific IgG1 antibody

Study Details

The purpose of this study is to measure the efficacy of the study drug, epcoritamab, in participants with relapsed/refractory large B-cell lymphoma.

Key Dates

Start date

Jun 5, 2025

Status verified

Feb 2026

Primary completion

Oct 1, 2026

Completion

Oct 1, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Epcoritamab
  Epcoritamab will be a subcutaneous injection on cycle 1-3 days 1, 8, 15, and 22, cycle 4-9 days 1 and 15, and cycle 10 and onwards day 1. Participants in a complete response will discontinue epcoritamab therapy after 12 cycles. Participants in a partial response or with stable disease at 1 year will continue epcoritamab and will discontinue at 18 or 24 months if in a complete response by those timepoints, otherwise they will continue until progression or intolerance. Dexamethasone (prophylactic corticosteroid) will be given during initial doses of study treatment. Dexamethasone will be taken either once daily or twice daily while receiving epcoritamab. A drug diary will be provided to participants to document information about dexamethasone being taken.

Primary Outcome Measure

12-month progression free survival (PFS) [ Time Frame: Day 1 until date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 12 months after initial dose of study treatment. ]

Central Contacts

• Julie E. Haydu, MD, PhD
  617-724-4000
  [email protected]

Locations (2)

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