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
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
3 other identifiers
interventional
264
13 countries
76
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2022
Longer than P75 for phase_2
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedStudy Start
First participant enrolled
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2032
July 7, 2026
July 1, 2026
10.4 years
March 9, 2022
July 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Dose-Limiting Toxicities (DLT)
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Up to Approximately 5 Years
Secondary Outcomes (8)
Best Overall Response (BOR) per Investigator
Up to Approximately 5 Years
Duration of response (DOR) per Investigator
Up to Approximately 5 Years
Number of Participants with Progression-free survival (PFS)
Up to Approximately 5 Years
Percentage of Participants with Complete Response (CR)
Up to Approximately 5 Years
Time-to-response (TTR)
Up to Approximately 5 Years
- +3 more secondary outcomes
Study Arms (13)
Arm 1: Dose Escalation
EXPERIMENTALParticipants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) will receive escalating doses of epcoritamab in combination with lenalidomide in 28 day cycles.
Arm 2: Dose Escalation
EXPERIMENTALParticipants with R/R DLBCL will receive escalating doses of epcoritamab in combination with ibrutinib and lenalidomide in 28 day cycles.
Arm 3: Dose Escalation
EXPERIMENTALParticipants with newly diagnosed treatment-naïve DLBCL will receive escalating doses of epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin hydrochloride (HCl), and prednisone (pola-R-CHP) in 21 day cycles.
Arm 4: Dose Escalation
EXPERIMENTALParticipants with R/R DLBCL will receive escalating doses of epcoritamab in combination with CC-99282 in 28 day cycles.
Arm 5: Dose Escalation
EXPERIMENTALParticipants with R/R follicular lymphoma (FL) will receive escalating doses of epcoritamab in combination with CC-99282 in 28 day cycles.
Arm 6A: Dose Escalation
EXPERIMENTALParticipants with R/R mantle cell lymphoma (MCL) will receive escalating doses of epcoritamab in combination with ibrutinib in 28 day cycles.
Arm 1: Dose Expansion
EXPERIMENTALParticipants with R/R DLBCL will receive the recommended dose of epcoritamab in combination with lenalidomide in 28 day cycles.
Arm 2: Dose Expansion
EXPERIMENTALParticipants with R/R DLBCL will receive the recommended dose of epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.
Arm 3: Dose Expansion
EXPERIMENTALParticipants newly diagnosed treatment-naïve DLBCL will receive the recommended dose of epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin hydrochloride (HCl), and prednisone (pola-R-CHP) in 21 day cycles.
Arm 3B: Dose Expansion
EXPERIMENTALParticipants newly diagnosed treatment-naïve DLBCL will receive the recommended dose of epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin hydrochloride (HCl), and prednisone (pola-R-CHP), in 21 day cycles,until unacceptable toxicity, withdrawal of consent, or completion of treatment.
Arm 4: Dose Expansion
EXPERIMENTALParticipants with R/R DLBCL will receive the recommended dose of epcoritamab in combination with CC-99282 in 28 day cycles.
Arm 5: Dose Expansion
EXPERIMENTALParticipants with R/R FL will receive the recommended dose of epcoritamab in combination with CC-99282 in 28 day cycles.
Arm 6: Dose Expansion
EXPERIMENTALParticipants with R/R MCL will receive the recommended dose of epcoritamab in combination with ibrutinib in 28 day cycles.
Interventions
Subcutaneous Injection (SC)
Oral; Capsule
Oral; Capsule
Intravenous (IV); Injection
IV; Injection
Oral; Capsule
IV; Injection
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (76)
The University of Arizona Cancer Center - North Campus /ID# 242219
Tucson, Arizona, 85719, United States
Yale University School of Medicine /ID# 242089
New Haven, Connecticut, 06510, United States
Christiana Care Health Service /ID# 242301
Newark, Delaware, 19713, United States
Tampa General Hospital /ID# 246748
Tampa, Florida, 33606, United States
Winship Cancer Institute of Emory University /ID# 242153
Atlanta, Georgia, 30322, United States
University of Maryland, Baltimore /ID# 242218
Baltimore, Maryland, 21201, United States
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144
Kansas City, Missouri, 64114-4859, United States
Northwell Health - Monter Cancer Center /ID# 245435
Lake Success, New York, 11042, United States
Icahn School of Medicine at Mount Sinai /ID# 242123
New York, New York, 10029, United States
Novant Health Presbyterian Medical Center /ID# 242148
Charlotte, North Carolina, 28204, United States
East Carolina University - Brody School of Medicine /ID# 242506
Greenville, North Carolina, 27834, United States
Novant Health Forsyth Medical Center /ID# 242198
Winston-Salem, North Carolina, 27103, United States
Thomas Jefferson University Hospital /ID# 242077
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center /ID# 242106
Philadelphia, Pennsylvania, 19111, United States
Thompson Cancer Survival Ctr /ID# 242150
Knoxville, Tennessee, 37916, United States
Joe Arrington Cancer Research /ID# 242226
Lubbock, Texas, 79410, United States
Swedish Medical Center - Seattle /ID# 242269
Seattle, Washington, 98104, United States
MultiCare Institute for Research and Innovation /ID# 242127
Tacoma, Washington, 98405, United States
Beijing Cancer Hospital /ID# 252303
Beijing, Beijing Municipality, 100142, China
Fudan University Shanghai Cancer Center /ID# 252292
Shanghai, Shanghai Municipality, 200032, China
Fakultni Nemocnice Brno - Jihlavska /ID# 242683
Brno, Brno-mesto, 625 00, Czechia
Fakultni Nemocnice Ostrava /ID# 242684
Ostrava, Ostrava-mesto, 708 52, Czechia
Vseobecna Fakultni nemocnice v Praze /ID# 242685
Prague, Praha 17, 128 00, Czechia
Fakultni nemocnice Hradec Kralove - Sokolska /ID# 241722
Hradec Králové, 500 05, Czechia
Aarhus Universitetshospital - Skejby /ID# 242670
Aarhus, Central Jutland, 8200, Denmark
Aalborg University Hospital /ID# 242734
Aalborg, North Denmark, 9000, Denmark
CHU Clermont-Ferrand /ID# 242344
Clermont, Auvergne-Rhône-Alpes, 63100, France
CHU de Rennes - PONTCHAILLOU /ID# 242339
Rennes, Brittany Region, 35000, France
Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 242342
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France
CHRU Lille - Hopital Claude Huriez /ID# 242335
Lille, Nord, 59037, France
IUCT Oncopole /ID# 242340
Toulouse, Occitanie, 31059, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 242337
Créteil, Paris, 94010, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 242345
Nantes, Pays de la Loire Region, 44000, France
HCL - Hopital Lyon Sud /ID# 242349
Pierre-Bénite, Rhone, 69495, France
Hopital Saint-Louis /ID# 242336
Paris, 75010, France
Hopital Pitie Salpetriere /ID# 242343
Paris, Île-de-France Region, 75013, France
Universitaetsklinikum Ulm /ID# 244265
Ulm, Baden-Wurttemberg, 89081, Germany
Klinikum Augsburg /ID# 244523
Augsburg, Bavaria, 86156, Germany
Universitaetsklinikum Regensburg /ID# 244517
Regensburg, Bavaria, 93042, Germany
Universitaetsklinikum Wuerzburg /ID# 245453
Würzburg, Bavaria, 97080, Germany
Universitaetsklinikum Giessen und Marburg /ID# 245308
Marburg, Hesse, 35043, Germany
Universitaetsklinikum Leipzig /ID# 245513
Leipzig, Saxony, 04103, Germany
Debreceni Egyetem-Klinikai Kozpont /ID# 242450
Debrecen, Hajdú-Bihar, 4032, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935
Kaposvár, Somogy County, 7400, Hungary
Semmelweis Egyetem /ID# 242454
Budapest, 1085, Hungary
Orszagos Onkologiai Intezet /ID# 242458
Budapest, 1122, Hungary
Rabin Medical Center. /ID# 243014
Petah Tikva, Central District, 4941492, Israel
Hadassah Medical Center-Hebrew University /ID# 243013
Jerusalem, Jerusalem, 91120, Israel
The Chaim Sheba Medical Center /ID# 243010
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 243012
Tel Aviv, Tel Aviv, 6423906, Israel
Hokkaido University Hospital /ID# 248999
Sapporo, Hokkaido, 060-8648, Japan
Kyoto University Hospital /ID# 248997
Kyoto, Kyoto, 606-8507, Japan
National Cancer Center Hospital /ID# 248995
Chuo-ku, Tokyo, 104-0045, Japan
Maastricht Universitair Medisch Centrum /ID# 243317
Maastricht, Limburg, 6229 HX, Netherlands
Vrije Universiteit Medisch Centrum /ID# 243319
Amsterdam, North Holland, 1081 HV, Netherlands
Leids Universitair Medisch Centrum /ID# 243316
Leiden, South Holland, 2333 ZA, Netherlands
Duplicate_Erasmus Medisch Centrum /ID# 243315
Rotterdam, South Holland, 3015 GD, Netherlands
Universitair Medisch Centrum Groningen /ID# 243318
Groningen, 9713 GZ, Netherlands
Seoul National University Bundang Hospital /ID# 242404
Seongnam-si, Gyeonggido, 13620, South Korea
Seoul National University Hospital /ID# 242402
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Asan Medical Center /ID# 242400
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Samsung Medical Center /ID# 242401
Seoul, Seoul Teugbyeolsi, 06351, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 242403
Seoul, Seoul Teugbyeolsi, 06591, South Korea
Instituto Catalan de Oncologia (ICO) Badalona /ID# 243265
Badalona, Barcelona, 08916, Spain
Institut Catala dOncologia - LHospitalet /ID# 243261
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Clinica Universidad de Navarra - Pamplona /ID# 245031
Pamplona, Navarre, 31008, Spain
Hospital Universitario Vall de Hebron /ID# 243260
Barcelona, 08035, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 243268
Madrid, 28027, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 243264
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre /ID# 243262
Madrid, 28041, Spain
Hospital Universitario de Salamanca /ID# 243368
Salamanca, 37711, Spain
Hospital Universitario Virgen del Rocio /ID# 243267
Seville, 41013, Spain
Hospital Clinico Universitario de Valencia /ID# 243269
Valencia, 46010, Spain
China Medical University Hospital /ID# 242893
Taichung, 40447, Taiwan
National Cheng Kung University Hospital /ID# 242894
Tainan, 704, Taiwan
Taipei Veterans General Hosp /ID# 242892
Taipei, 11217, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2022
First Posted
March 17, 2022
Study Start
June 14, 2022
Primary Completion (Estimated)
November 1, 2032
Study Completion (Estimated)
November 1, 2032
Last Updated
July 7, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.