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)
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)
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 relapsed or refractory (R/R) 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 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world.
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).
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:
Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
Participant has:
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+ disease on most recent 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:
Tucson, Arizona 85719, United States
Chicago, Illinois 60611-2927, United States
Billings, Montana 59102, United States
New York, New York 10065-6007, United States
Greenville, North Carolina 27834, United States
Oklahoma City, Oklahoma 73104-5418, United States
Richmond, Virginia 23219, United States
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1114, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1431, Argentina
Córdoba, 5016, Argentina
Santa Fe, 3000, Argentina
Curitiba, Paraná 80060-900, Brazil
Jaú, São Paulo 17210-070, Brazil
São Paulo, São Paulo 01509-900, Brazil
São Paulo, 04039-901, Brazil
São Paulo, 05403-000, Brazil
Wuhan, Hubei 430048, China
Hangzhou, Zhejiang 310003, China
Hangzhou, Zhejiang 310009, China
Hradec Králové, Hradec Kralove 500 05, Czechia
Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54511, France
Nantes, Pays de la Loire Region 44000, France
La Roche-sur-Yon, Vendee 85925, France
Athens, 10676, Greece
Nyíregyháza, Szabolcs-Szatmár-Bereg 4400, Hungary
Budapest, 1097, Hungary
San Giovanni Rotondo, Foggia 71013, Italy
Turin, Piedmont 10126, Italy
Rome, Roma 00168, Italy
Candiolo, Torino 10060, Italy
Alessandria, 15100, Italy
Kashiwa-shi, Chiba 277-8577, Japan
Sagamihara-shi, Kanagawa 252-0375, Japan
Matsumoto-shi, Nagano 390-8621, Japan
Sakai-shi, Osaka 590-0197, Japan
Chuo-ku, Tokyo 104-0045, Japan
Koto-ku, Tokyo 135-8550, Japan
Rotterdam, South Holland 3045 PM, Netherlands
Kielce, Świętokrzyskie Voivodeship 25-734, Poland
Daegu, Gyeongsangbuk-do 42601, South Korea
Seoul, Seoul Teugbyeolsi 06591, South Korea
L'Hospitalet de Llobregat, Barcelona 08907, Spain
Istanbul, 34098, Turkey (Türkiye)
Istanbul, 34899, Turkey (Türkiye)
London, Greater London E1 2ES, United Kingdom
Oxford, Oxfordshire OX3 9DU, United Kingdom
Newcastle upon Tyne, NE3 3HD, United Kingdom