Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma

Summary

Follicular lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with previously untreated FL. Adverse events and change in disease condition will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 5 groups, called treatment arms. Each group receives a different treatment. Around 1095 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world.

Participants will receive R2 (intravenous \[IV\] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) \[G-CHOP\]/ R-CHOP or G and IV infusion of bendamustine (Benda) \[G-Benda\]/R-Benda. The total treatment duration will be 120 weeks for all arms except A2, which is 24 weeks of treatment.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions

• Follicular Lymphoma (FL)

Interventions

DRUG

Epcoritamab

Subcutaneous (SC) Injection

DRUG

Prednisone

Oral Tablet

DRUG

Rituximab

Intravenous (IV) Infusion

DRUG

Lenalidomide

Oral Capsule

DRUG

Doxorubicin

IV Injection

DRUG

Vincristine

IV Injection

DRUG

Cyclophosphamide

IV Injection

DRUG

Obinutuzumab

IV Infusion

DRUG

Bendamustine

IV Infusion

Sponsors & Collaborators

• AbbVie

  collaborator INDUSTRY

• Genmab

  lead INDUSTRY

Principal Investigators

• ABBVIE INC. · AbbVie

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-05

Primary Completion

2037-11-30

Completion

2037-11-30

FDA Drug

Yes

Countries

• United States
• Australia
• Belgium
• Brazil
• Bulgaria
• Canada
• China
• Croatia
• Czechia
• Denmark
• France
• Germany
• Greece
• Hungary
• Israel
• Italy
• Japan
• Netherlands
• New Zealand
• Poland
• Portugal
• Puerto Rico
• Romania
• Serbia
• Slovakia
• South Africa
• South Korea
• Spain
• Sweden
• Taiwan
• Turkey (Türkiye)
• United Kingdom

Study Locations