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A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
NCT05283720 · Genmab
In plain English
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Official title
Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma
About this study
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 496 adult participants with NHL will be enrolled in 100 sites globally.
In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28 day, 21 day, or 56 day cycles dependent on the arm in combination with the anti-neoplastic agents described below:
1: Oral lenalidomide in participants (PPTS) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in PPTS with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in PPTS with newly diagnosed treatment-naïve DLBCL, or completion of treatment in 3B; 4: Oral CC-99282 in PPTS with R/R DLBCL; 5: Oral CC-99282 in PPTS with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in PPTS with R/R mantle cell lymphoma (MCL).
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.
Eligibility criteria
Inclusion Criteria:
* Diagnosis of:
\-- Diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma (FL) or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:
* DLBCL, not otherwise specified (NOS).
* High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible.
* Follicular lymphoma (FL) Grade 3B. OR
* FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR
* Mantle cell lymphoma (MCL) with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR).
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2, except for Arm 6A where ECOG performance status must be 0-1.
* Must have 1 or more measurable disease sites:
* A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND
* At least 1 measurable nodal lesion (long axis \> 1.5 cm) or \>= 1 measurable extra-nodal lesion (long axis \> 1.0 cm) on CT scan or magnetic resonance imaging (MRI).
Exclusion Criteria:
* Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.
* Toxicities from prior anticancer therapy that have not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia. Other eligibility criteria (e.g., laboratory, cardiac criteria) must also be met.
Study design
Enrollment target: 496 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-06-14
Estimated completion: 2032-11
Last updated: 2026-04-13
Interventions
Drug: EpcoritamabDrug: LenalidomideDrug: IbrutinibDrug: RituximabDrug: CyclophosphamideDrug: Doxorubicin Hydrochloride [HCl]Drug: PrednisoneDrug: Polatuzumab VedotinDrug: CC-99282
Primary outcomes
- • Number of Participants with Dose-Limiting Toxicities (DLT) (Up to Approximately 5 Years)
Sponsor
Genmab · industry
With: AbbVie
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (75)
The University of Arizona Cancer Center - North Campus /ID# 242219Completed
Tucson, Arizona, United States
Yale University School of Medicine /ID# 242089Recruiting
New Haven, Connecticut, United States
Christiana Care Health Service /ID# 242301Recruiting
Newark, Delaware, United States
Tampa General Hospital /ID# 246748Recruiting
Tampa, Florida, United States
Winship Cancer Institute of Emory University /ID# 242153Completed
Atlanta, Georgia, United States
University of Maryland, Baltimore /ID# 242218Recruiting
Baltimore, Maryland, United States
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144Completed
Kansas City, Missouri, United States
Northwell Health - Monter Cancer Center /ID# 245435Recruiting
Lake Success, New York, United States
Icahn School of Medicine at Mount Sinai /ID# 242123Recruiting
New York, New York, United States
Novant Health Presbyterian Medical Center /ID# 242148Completed
Charlotte, North Carolina, United States
East Carolina University - Brody School of Medicine /ID# 242506Recruiting
Greenville, North Carolina, United States
Novant Health Forsyth Medical Center /ID# 242198Completed
Winston-Salem, North Carolina, United States
Thomas Jefferson University Hospital /ID# 242077Completed
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center /ID# 242106Completed
Philadelphia, Pennsylvania, United States
Thompson Cancer Survival Ctr /ID# 242150Completed
Knoxville, Tennessee, United States
Joe Arrington Cancer Research /ID# 242226Completed
Lubbock, Texas, United States
Swedish Medical Center - Seattle /ID# 242269Recruiting
Seattle, Washington, United States
MultiCare Institute for Research & Innovation /ID# 242127Completed
Tacoma, Washington, United States
Beijing Cancer Hospital /ID# 252303Recruiting
Beijing, Beijing Municipality, China
Fakultni Nemocnice Brno - Jihlavska /ID# 242683Recruiting
Brno, Brno-mesto, Czechia
Fakultní nemocnice Hradec Králové - Sokolská /ID# 241722Recruiting
Hradec Králové, Hradec Kralove, Czechia
Fakultni Nemocnice Ostrava /ID# 242684Recruiting
Ostrava, Ostrava-mesto, Czechia
Vseobecna Fakultni nemocnice v Praze /ID# 242685Recruiting
Prague, Praha 17, Czechia
Aarhus Universitetshospital - Skejby /ID# 242670Recruiting
Aarhus, Central Jutland, Denmark
Aalborg University Hospital /ID# 242734Completed
Aalborg, North Denmark, Denmark
CHU Clermont-Ferrand /ID# 242344Recruiting
Clermont, Auvergne-Rhône-Alpes, France
CHU de Rennes - PONTCHAILLOU /ID# 242339Recruiting
Rennes, Brittany Region, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 242342Recruiting
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHRU Lille - Hopital Claude Huriez /ID# 242335Completed
Lille, Nord, France
IUCT Oncopole /ID# 242340Recruiting
Toulouse, Occitanie, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 242337Recruiting
Créteil, Paris, France
Hopital Saint-Louis /ID# 242336Recruiting
Paris, Paris, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 242345Recruiting
Nantes, Pays de la Loire Region, France
HCL - Hopital Lyon Sud /ID# 242349Recruiting
Pierre-Bénite, Rhone, France
Hopital Pitie Salpetriere /ID# 242343Recruiting
Paris, Île-de-France Region, France
Universitaetsklinikum Ulm /ID# 244265Recruiting
Ulm, Baden-Wurttemberg, Germany
Klinikum Augsburg /ID# 244523Recruiting
Augsburg, Bavaria, Germany
Universitaetsklinikum Regensburg /ID# 244517Recruiting
Regensburg, Bavaria, Germany
Universitaetsklinikum Wuerzburg /ID# 245453Recruiting
Würzburg, Bavaria, Germany
Universitaetsklinikum Giessen und Marburg /ID# 245308Recruiting
Marburg, Hesse, Germany
Universitaetsklinikum Leipzig /ID# 245513Recruiting
Leipzig, Saxony, Germany
Semmelweis Egyetem /ID# 242454Recruiting
Budapest, Budapest, Hungary
Debreceni Egyetem-Klinikai Kozpont /ID# 242450Recruiting
Debrecen, Hajdú-Bihar, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935Recruiting
Kaposvár, Somogy County, Hungary
Orszagos Onkologiai Intezet /ID# 242458Recruiting
Budapest, Hungary
Hadassah Medical Center-Hebrew University /ID# 243013Recruiting
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 243010Recruiting
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 243012Recruiting
Tel Aviv, Tel Aviv, Israel
Rabin Medical Center. /ID# 243014Recruiting
Petah Tikva, Israel
Hokkaido University Hospital /ID# 248999Recruiting
Sapporo, Hokkaido, Japan
Kyoto University Hospital /ID# 248997Completed
Kyoto, Kyoto, Japan
National Cancer Center Hospital /ID# 248995Recruiting
Chuo-ku, Tokyo, Japan
Maastricht Universitair Medisch Centrum /ID# 243317Completed
Maastricht, Limburg, Netherlands
Vrije Universiteit Medisch Centrum /ID# 243319Recruiting
Amsterdam, North Holland, Netherlands
Universitair Medisch Centrum Groningen /ID# 243318Completed
Groningen, Provincie Groningen, Netherlands
Leids Universitair Medisch Centrum /ID# 243316Completed
Leiden, South Holland, Netherlands
Duplicate_Erasmus Medisch Centrum /ID# 243315Completed
Rotterdam, South Holland, Netherlands
Seoul National University Bundang Hospital /ID# 242404Recruiting
Seongnam-si, Gyeonggido, South Korea
Seoul National University Hospital /ID# 242402Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 242400Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 242401Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 242403Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Instituto Catalan de Oncologia (ICO) Badalona /ID# 243265Recruiting
Badalona, Barcelona, Spain
Hospital Universitario Vall de Hebron /ID# 243260Recruiting
Barcelona, Barcelona, Spain
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 243261Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 243268Recruiting
Madrid, Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 243264Recruiting
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 243262Recruiting
Madrid, Madrid, Spain
Clinica Universidad de Navarra - Pamplona /ID# 245031Recruiting
Pamplona, Navarre, Spain
Hospital Universitario de Salamanca /ID# 243368Recruiting
Salamanca, Salamanca, Spain
Hospital Universitario Virgen del Rocio /ID# 243267Recruiting
Seville, Sevilla, Spain
Hospital Clinico Universitario de Valencia /ID# 243269Recruiting
Valencia, Valencia, Spain
China Medical University Hospital /ID# 242893Recruiting
Taichung, Taichung, Taiwan
National Cheng Kung University Hospital /ID# 242894Recruiting
Tainan, Tainan, Taiwan
Taipei Veterans General Hosp /ID# 242892Recruiting
Taipei, Taipei, Taiwan