A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)
A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)
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.
Inclusion Criteria:
Diagnosis of follicular lymphoma (FL).
Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.
Are willing and able to comply with procedures required in the protocol.
Must have stage, III, IV or II with bulky disease >= 7cm).
Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
Has one or more target lesions:
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: [Arm B] at the discretion of the Investigator, and rituximab and lenalidomide (R2) [Arm C].
Have laboratory values meeting the criteria in the protocol.
Exclusion Criteria:
Jacksonville, Florida 32256, United States
Chicago, Illinois 60611, United States
Fort Wayne, Indiana 46804, United States
Bethesda, Maryland 20817, United States
Billings, Montana 59102, United States
Grand Island, Nebraska 68803, United States
Albany, New York 12206-5013, United States
Nashville, Tennessee 37203, United States
Dallas, Texas 75246-2003, United States
Roanoke, Virginia 98684, United States
Melbourne, New South Wales 3000, Australia
Jaú, São Paulo 17210-070, Brazil
Ribeirão Preto, São Paulo 14049-900, Brazil
São Paulo, São Paulo 01509-900, Brazil
São Paulo, 05403-000, Brazil
Montreal, Quebec H4A 3J1, Canada
Wuhan, Hubei 430048, China
Tianjin, Tianjin Municipality 300020, China
Ürümqi, Xinjiang 830000, China
Hangzhou, Zhejiang 310003, China
Wenzhou, Zhejiang 325000, China
Copenhagen Ø, Capital Region 2100, Denmark
Athens, 10676, Greece
Győr, Győr-Moson-Sopron 9024, Hungary
Budapest, 1097, Hungary
Afula, Haifa District 1834111, Israel
Candiolo, Torino 10060, Italy
Yoshida-gun, Fukui 910-1104, Japan
Hitachi-shi, Ibaraki 317-0077, Japan
Sagamihara-shi, Kanagawa 252-0375, Japan
Hirakata-shi, Osaka 573-1191, Japan
Sakai-shi, Osaka 590-0197, Japan
Bunkyo Ku, Tokyo 113-8677, Japan
Bunkyo-ku, Tokyo 113-8654, Japan
Chuo-shi, Yamanashi 409-3898, Japan
Rotterdam, South Holland 3045 PM, Netherlands
Warsaw, Masovian Voivodeship 02-781, Poland
Lodz, Łódź Voivodeship 93-513, Poland
Kielce, Świętokrzyskie Voivodeship 25-734, Poland
Vila Nova de Gaia, Porto District 4434-502, Portugal
L'Hospitalet de Llobregat, Barcelona 08907, Spain
Istanbul, 34899, Turkey (Türkiye)