[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)

JRCT ID: jRCT2021230024

Registered date:14/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Follicular Lymphoma
• Date of first enrollment: 27/12/2023
• Target sample size: 520
• Countries of recruitment: Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Netherlands,Japan,New Zealand,Japan,Poland,Japan,South Africa,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,Taiwan,Japan,Turkey,Japan,Argentina,Japan,China,Japan,Puerto Rico,Japan,UK,Japan,US,Japan
• Study type: Interventional
• Intervention(s): 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 injections of epcoritamab for up to 12 cycles (each cycle is 28 days).

Outcome(s)

• Primary Outcome: Progression-Free Survival (PFS)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude criteria

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

Related Information

• Primary Sponsor: Satomi Natsuko
• Secondary Sponsor: Genmab K.K.
• Secondary ID(s): NCT05409066