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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
Sponsor: Genmab
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
496
Start Date
2022-06-14
Completion Date
2032-11
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
Epcoritamab
Subcutaneous Injection (SC)
Lenalidomide
Oral; Capsule
Ibrutinib
Oral; Capsule
Rituximab
Intravenous (IV); Injection
Cyclophosphamide
IV; Injection
Doxorubicin Hydrochloride [HCl]
IV; Injection
Prednisone
Oral; Tablet
Polatuzumab Vedotin
IV; Injection
CC-99282
Oral; Capsule
Locations (75)
The University of Arizona Cancer Center - North Campus /ID# 242219
Tucson, Arizona, United States
Yale University School of Medicine /ID# 242089
New Haven, Connecticut, United States
Christiana Care Health Service /ID# 242301
Newark, Delaware, United States
Tampa General Hospital /ID# 246748
Tampa, Florida, United States
Winship Cancer Institute of Emory University /ID# 242153
Atlanta, Georgia, United States
University of Maryland, Baltimore /ID# 242218
Baltimore, Maryland, United States
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144
Kansas City, Missouri, United States
Northwell Health - Monter Cancer Center /ID# 245435
Lake Success, New York, United States
Icahn School of Medicine at Mount Sinai /ID# 242123
New York, New York, United States
Novant Health Presbyterian Medical Center /ID# 242148
Charlotte, North Carolina, United States
East Carolina University - Brody School of Medicine /ID# 242506
Greenville, North Carolina, United States
Novant Health Forsyth Medical Center /ID# 242198
Winston-Salem, North Carolina, United States
Thomas Jefferson University Hospital /ID# 242077
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center /ID# 242106
Philadelphia, Pennsylvania, United States
Thompson Cancer Survival Ctr /ID# 242150
Knoxville, Tennessee, United States
Joe Arrington Cancer Research /ID# 242226
Lubbock, Texas, United States
Swedish Medical Center - Seattle /ID# 242269
Seattle, Washington, United States
MultiCare Institute for Research & Innovation /ID# 242127
Tacoma, Washington, United States
Beijing Cancer Hospital /ID# 252303
Beijing, Beijing Municipality, China
Fakultni Nemocnice Brno - Jihlavska /ID# 242683
Brno, Brno-mesto, Czechia
Fakultní nemocnice Hradec Králové - Sokolská /ID# 241722
Hradec Králové, Hradec Kralove, Czechia
Fakultni Nemocnice Ostrava /ID# 242684
Ostrava, Ostrava-mesto, Czechia
Vseobecna Fakultni Nemocnice v Praze /ID# 242685
Prague, Praha 17, Czechia
Aarhus Universitetshospital - Skejby /ID# 242670
Aarhus, Central Jutland, Denmark
Aalborg University Hospital /ID# 242734
Aalborg, North Denmark, Denmark
CHU Clermont-Ferrand /ID# 242344
Clermont, Auvergne-Rhône-Alpes, France
CHU de Rennes - PONTCHAILLOU /ID# 242339
Rennes, Brittany Region, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 242342
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHRU Lille - Hopital Claude Huriez /ID# 242335
Lille, Nord, France
IUCT Oncopole /ID# 242340
Toulouse, Occitanie, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 242337
Créteil, Paris, France
Hopital Saint-Louis /ID# 242336
Paris, Paris, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 242345
Nantes, Pays de la Loire Region, France
HCL - Hopital Lyon Sud /ID# 242349
Pierre-Bénite, Rhone, France
Hopital Pitie Salpetriere /ID# 242343
Paris, Île-de-France Region, France
Universitaetsklinikum Ulm /ID# 244265
Ulm, Baden-Wurttemberg, Germany
Klinikum Augsburg /ID# 244523
Augsburg, Bavaria, Germany
Universitaetsklinikum Wuerzburg /ID# 245453
Würzburg, Bavaria, Germany
Universitaetsklinikum Giessen und Marburg /ID# 245308
Marburg, Hesse, Germany
Universitaetsklinikum Leipzig /ID# 245513
Leipzig, Saxony, Germany
Universitaetsklinikum Regensburg /ID# 244517
Regensburg, Germany
Semmelweis Egyetem /ID# 242454
Budapest, Budapest, Hungary
Debreceni Egyetem-Klinikai Kozpont /ID# 242450
Debrecen, Hajdú-Bihar, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935
Kaposvár, Somogy County, Hungary
Orszagos Onkologiai Intezet /ID# 242458
Budapest, Hungary
Hadassah Medical Center-Hebrew University /ID# 243013
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 243010
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 243012
Tel Aviv, Tel Aviv, Israel
Rabin Medical Center. /ID# 243014
Petah Tikva, Israel
Hokkaido University Hospital /ID# 248999
Sapporo, Hokkaido, Japan
Kyoto University Hospital /ID# 248997
Kyoto, Kyoto, Japan
National Cancer Center Hospital /ID# 248995
Chuo-ku, Tokyo, Japan
Maastricht Universitair Medisch Centrum /ID# 243317
Maastricht, Limburg, Netherlands
Vrije Universiteit Medisch Centrum /ID# 243319
Amsterdam, North Holland, Netherlands
Universitair Medisch Centrum Groningen /ID# 243318
Groningen, Provincie Groningen, Netherlands
Leids Universitair Medisch Centrum /ID# 243316
Leiden, South Holland, Netherlands
Duplicate_Erasmus Medisch Centrum /ID# 243315
Rotterdam, South Holland, Netherlands
Seoul National University Bundang Hospital /ID# 242404
Seongnam-si, Gyeonggido, South Korea
Seoul National University Hospital /ID# 242402
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 242400
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 242401
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 242403
Seoul, Seoul Teugbyeolsi, South Korea
Instituto Catalan de Oncologia (ICO) Badalona /ID# 243265
Badalona, Barcelona, Spain
Hospital Universitario Vall de Hebron /ID# 243260
Barcelona, Barcelona, Spain
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 243261
L'Hospitalet de Llobregat, Barcelona, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 243268
Madrid, Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 243264
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 243262
Madrid, Madrid, Spain
Clinica Universidad de Navarra - Pamplona /ID# 245031
Pamplona, Navarre, Spain
Hospital Universitario de Salamanca /ID# 243368
Salamanca, Salamanca, Spain
Hospital Universitario Virgen del Rocio /ID# 243267
Seville, Sevilla, Spain
Hospital Clinico Universitario de Valencia /ID# 243269
Valencia, Valencia, Spain
China Medical University Hospital /ID# 242893
Taichung, Taichung, Taiwan
National Cheng Kung University Hospital /ID# 242894
Tainan, Tainan, Taiwan
Taipei Veterans General Hosp /ID# 242892
Taipei, Taipei, Taiwan