A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally.
In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.
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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Inclusion Criteria:
Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.
Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:
Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.
Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.
Availability of archival or fresh or paraffin embedded tissue at Screening.
Must have an IPI score of 2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.
Has at least one target lesion defined as:
Laboratory values meeting the criteria laid out in the protocol.
Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.
Exclusion Criteria:
Tucson, Arizona 85719-1478, United States
Los Alamitos, California 90720-3309, United States
Aurora, Colorado 80014, United States
Ann Arbor, Michigan 48109, United States
Saint Louis Park, Minnesota 55416, United States
Billings, Montana 59102, United States
East Brunswick, New Jersey 08816, United States
New Hyde Park, New York 11042, United States
New York, New York 10016-4744, United States
New York, New York 10065-6007, United States
Port Jefferson Station, New York 11776-8060, United States
The Bronx, New York 10469, United States
Greenville, North Carolina 27834, United States
Oklahoma City, Oklahoma 73104-5418, United States
Charlottesville, Virginia 22903-3363, United States
Richmond, Virginia 23219, United States
Woluwe-Saint-Lambert, Brussels Capital 1200, Belgium
Yvoir, Namur 5530, Belgium
Curitiba, Paraná 80060-900, Brazil
Jaú, São Paulo 17210-070, Brazil
São Paulo, São Paulo 01509-900, Brazil
São Paulo, São Paulo 05652-900, Brazil
São Paulo, 05403-000, Brazil
Beijing, Beijing Municipality 100071, China
Wuhan, Hubei 430022, China
Tianjin, Tianjin Municipality 300020, China
Hangzhou, Zhejiang 310003, China
Hangzhou, Zhejiang 310009, China
Hradec Králové, Hradec Kralove 500 05, Czechia
Copenhagen Ø, Capital Region 2100, Denmark
Athens, 10676, Greece
Győr, Győr-Moson-Sopron 9024, Hungary
Tel Aviv, Central District 6971028, Israel
Bologna, Emilia-Romagna 40138, Italy
San Giovanni Rotondo, Foggia 71013, Italy
Turin, Piedmont 10126, Italy
Meldola, Reggio Emilia 47014, Italy
Candiolo, Torino 10060, Italy
Alessandria, 15100, Italy
Kashiwa-shi, Chiba 277-8577, Japan
Osakasayama-shi, Osaka 589-8511, Japan
Suita-shi, Osaka 565-0871, Japan
Chuo-ku, Tokyo 104-0045, Japan
Koto-ku, Tokyo 135-8550, Japan
Słupsk, Pomeranian Voivodeship 76-200, Poland
Olsztyn, Warmian-Masurian Voivodeship 10-228, Poland
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
Dilovası, Kocaeli 41455, Turkey (Türkiye)
Yüreğir, 01240, Turkey (Türkiye)
Norwich, Norfolk NR4 7UY, United Kingdom