[M20-638] A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)

[M20-638] A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1) - [M20-638] EPCORE FL-1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2021230024

Enrollment

520

Registered

2023-09-14

Start date

2023-12-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular Lymphoma

Interventions

Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injecti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2. - Participant has: -- Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND -- >= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI. - Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ on a representative tumor biopsy based on the pathology report. - Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.) - Eligible to receive R2 per investigator determination. - Estimated Creatinine Clearance (CrCl) >= 50 mL/min.

Exclusion criteria

Exclusion criteria: - Documented refractoriness to lenalidomide. - Have lenalidomide exposure within 12 months prior to randomization.

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival (PFS)	—

Secondary

Measure	Time frame
- Percentage of Participants Achieving Complete Response (CR) - Overall Survival (OS) - Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Poland, Puerto Rico, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, UK, US

Contacts

Public ContactContact for Patients and HCP

AbbVie G.K.

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026