Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma (EPCORE FL-1)

July 6, 2026 updated by: Genmab

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

549

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, 5016
        • Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 229701
      • Santa Fe, Argentina, 3000
        • Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 232124
    • Buenos Aires F.D.
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1114
        • Fundaleu /Id# 229700
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1431
        • Duplicate_CEMIC /ID# 229697
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital /ID# 239272
      • Kingswood, New South Wales, Australia, 2747
        • Nepean Hospital /ID# 239093
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Townsville University Hospital /ID# 231124
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Peninsula Private Hospital /ID# 238796
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital /ID# 231122
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital /ID# 230456
      • Perth, Western Australia, Australia, 6009
        • Hollywood Private Hospital /ID# 251789
  • Austria
      • Salzburg, Austria, 5020
        • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 228366
    • Lower Austria
      • Sankt Pölten, Lower Austria, Austria, 3100
        • Universitaetsklinikum St. Poelten /ID# 234015
    • Upper Austria
      • Linz, Upper Austria, Austria, 4010
        • Ordensklinikum Linz GmbH Elisabethinen /ID# 247510
  • Belgium
      • Anderlecht, Belgium, 1070
        • Institut Jules Bordet /ID# 254676
      • Turnhout, Belgium, 2300
        • AZ Turnhout - Campus Sint-Elisabeth /ID# 231628
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Uza /Id# 228521
    • Hainaut
      • La Louvière, Hainaut, Belgium, 7100
        • Hospital La Louviere Site Jolimont - Helora /ID# 228520
    • Liege
      • Liège, Liege, Belgium, 4000
        • Groupe Sante CHC - Clinique du MontLegia /ID# 230415
    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
        • Vitaz /Id# 228525
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 247780
  • Brazil
      • Rio de Janeiro, Brazil, 20231-050
        • Instituto Nacional de Cancer (INCA) /ID# 228706
      • São Paulo, Brazil, 01323-001
        • Real e Benemérita Associação Portuguesa de Beneficência /ID# 228121
      • São Paulo, Brazil, 01401-002
        • Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 252918
      • São Paulo, Brazil, 04039-901
        • Instituto de Assistencia Medica ao Servidor Publico Estadual /ID# 230182
      • São Paulo, Brazil, 05403-000
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 228127
    • Paraná
      • Curitiba, Paraná, Brazil, 80060-900
        • Hospital de Clinicas da Universidade Federal do Parana /ID# 228123
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-686
        • Upeclin Fmb - Unesp /Id# 252912
      • Jaú, São Paulo, Brazil, 17210-070
        • Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 228129
      • São Paulo, São Paulo, Brazil, 01509-900
        • Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 228130
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute /ID# 249080
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 6V5
        • BC Cancer - Victoria /ID# 228850
    • Quebec
      • Lévis, Quebec, Canada, G6V 3Z1
        • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229896
      • Québec, Quebec, Canada, G1J 1Z4
        • CHUQ- Hôpital de l'Enfant-Jesus /ID# 231537
      • Rimouski, Quebec, Canada, G5L 5T1
        • CISSSBSL -Hopital regional de Rimouski /ID# 229894
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital /ID# 250517
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital /ID# 230885
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital /ID# 233919
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University /ID# 238427
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center /ID# 231463
      • Guangzhou, Guangdong, China, 510120
        • Guangdong Provincial Peoples Hospital（Huifu Campus） /ID# 232512
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University /ID# 230383
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Fourth Hospital of Hebei Medical University /ID# 238657
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital /ID# 230459
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital /ID# 232255
      • Wuhan, Hubei, China, 430048
        • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234153
    • Hunan
      • Changsha, Hunan, China, 410006
        • Hunan Cancer Hospital /ID# 232153
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University /ID# 232511
      • Xuzhou, Jiangsu, China, 221006
        • The Affiliated Hospital of Xuzhou Medical College /ID# 232513
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University /ID# 231047
      • Nanchang, Jiangxi, China, 330029
        • Jiangxi Provincial Cancer Hospital /ID# 232507
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • First Affiliated Hospital of China Medical University /ID# 232509
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital /ID# 238650
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Cancer Hospital /ID# 250475
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300000
        • Tianjin Cancer Hospital /ID# 230876
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Yunnan Cancer Hospital /ID# 232062
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230390
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 231250
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer hospital /ID# 231389
  • Czechia
      • Prague, Czechia, 150 00
        • Duplicate_Fakultni Nemocnice v Motole /ID# 228272
      • Prague, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady /ID# 228564
    • Hradec Kralove
      • Hradec Králové, Hradec Kralove, Czechia, 500 05
        • Fakultní nemocnice Hradec Králové - Sokolská /ID# 228269
    • Praha 17
      • Prague, Praha 17, Czechia, 128 00
        • Vseobecna Fakultni Nemocnice v Praze /ID# 228565
  • Denmark
    • Central Jutland
      • Herning, Central Jutland, Denmark, 7400
        • Regionshospitalet Godstrup /ID# 227466
    • Region Syddanmark
      • Vejle, Region Syddanmark, Denmark, 7100
        • Vejle Sygehus /ID# 227404
  • France
      • Paris, France, 75010
        • Hôpital Saint-Louis /ID# 232067
    • Auvergne-Rhône-Alpes
      • Clermont, Auvergne-Rhône-Alpes, France, 63100
        • CHU Clermont-Ferrand /ID# 238676
    • Brittany Region
      • Rennes, Brittany Region, France, 35000
        • CHU de Rennes - PONTCHAILLOU /ID# 230356
    • Calvados
      • Caen, Calvados, France, 14033
        • CHU de CAEN - Hopital de la Cote de Nacre /ID# 245929
    • Cote-d Or
      • Dijon, Cote-d Or, France, 21000
        • CHU Dijon /ID# 230354
    • Franche-Comte
      • Limoges, Franche-Comte, France, 87042
        • CHU Limoges - Dupuytren 1 /ID# 231450
    • Gard
      • Nîmes, Gard, France, 30029
        • CHU NIMES - Hopital Caremeau /ID# 230351
    • Marne
      • Reims, Marne, France, 51092
        • CHU Reims - Hôpital Robert Debre /ID# 248710
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
        • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 241595
    • New Aquitaine
      • Pessac, New Aquitaine, France, 33604
        • Centre Hospitalier Universitaire de Bordeaux /ID# 230347
    • Nord
      • Lille, Nord, France, 59037
        • CHRU Lille - Hopital Claude Huriez /ID# 230353
    • Occitanie
      • Toulouse, Occitanie, France, 31059
        • IUCT Oncopole /ID# 233486
    • Paris
      • Créteil, Paris, France, 94010
        • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 230358
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44000
        • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 245928
    • Rhone
      • Lyon, Rhone, France, 69373
        • Centre Leon Berard /ID# 230348
      • Pierre-Bénite, Rhone, France, 69495
        • HCL - Hopital Lyon Sud /ID# 231449
    • Vendee
      • La Roche-sur-Yon, Vendee, France, 85925
        • Centre Hospitalier Departemental Vendee (Chd Vendee) /ID# 234095
    • Vienne
      • Poitiers, Vienne, France, 86000
        • CHU Poitiers - La miletrie /ID# 230357
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75013
        • Hopital Pitie Salpetriere /ID# 230360
  • Germany
      • Bamberg, Germany, 96049
        • Sozialstiftung Bamberg /ID# 229184
      • Berlin, Germany, 13125
        • Helios Klinikum Berlin-Buch /ID# 229178
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen /ID# 229180
      • Trier, Germany, 54290
        • Klinikum Mutterhaus der Borromäerinnen /ID# 232354
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen /ID# 229663
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Universitaetsklinikum Wuerzburg /ID# 229278
    • Hesse
      • Giessen, Hesse, Germany, 35392
        • Universitaetsklinikum Giessen /ID# 234245
      • Kassel, Hesse, Germany, 34125
        • Klinikum Kassel /ID# 229185
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • Universitaetsmedizin Goettingen /ID# 230411
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Universitaetsklinikum Bonn /ID# 249401
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 229754
      • Leipzig, Saxony, Germany, 04103
        • Universitaetsklinikum Leipzig /ID# 242907
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • Otto-von-Guericke-Universitaet /ID# 230144
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Universitaetsklinikum Jena /ID# 232064
  • Greece
      • Athens, Greece, 10676
        • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 226633
      • Ioannina, Greece, 45500
        • University General Hospital of Ioannina /ID# 226628
      • Thessaloniki, Greece, 54636
        • General University Hospital of Thessaloniki AXEPA /ID# 226630
      • Thessaloniki, Greece, 54639
        • Theageneio Anticancer Hospital /ID# 226627
    • Attica
      • Athens, Attica, Greece, 11527
        • General Hospital of Athens Laiko /ID# 226626
      • Athens, Attica, Greece, 11528
        • Alexandra General Hospital /ID# 226632
      • Athens, Attica, Greece, 12462
        • University General Hospital Attikon /ID# 226629
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 229291
      • Budapest, Hungary, 1097
        • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 229286
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet /ID# 229292
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem /ID# 229289
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Debreceni Egyetem-Klinikai Kozpont /ID# 229287
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246475
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 232203
    • Vas County
      • Szombathely, Vas County, Hungary, 9700
        • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 229290
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus /ID# 227849
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center. /ID# 228043
    • Central District
      • Ẕerifin, Central District, Israel, 70300
        • Yitzhak Shamir Medical Center /ID# 228037
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 91120
        • Hadassah /ID# 227846
    • Northern District
      • Safed, Northern District, Israel, 13100
        • ZIV Medical Center /ID# 232257
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • The Chaim Sheba Medical Center /ID# 228322
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 228529
  • Italy
      • Alessandria, Italy, 15100
        • Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Aless /ID# 227401
      • Bari, Italy, 70124
        • Duplicate_I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 227400
      • Brescia, Italy, 25123
        • ASST degli Spedali Civili di Brescia /ID# 227397
      • Naples, Italy, 80131
        • Duplicate_Azienda Ospedaliera Universitaria Federico II /ID# 230403
      • Novara, Italy, 28100
        • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 227399
      • Palermo, Italy, 90146
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 227402
      • Ravenna, Italy, 48121
        • Ospedale Santa Maria Delle Croci /ID# 227394
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 228458
    • Milano
      • Milan, Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele /ID# 228669
      • Milan, Milano, Italy, 20141
        • Istituto Europeo Di Oncologia /ID# 227396
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229820
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Duplicate_Centro di Riferimento Oncologico /ID# 227395
    • Roma
      • Rome, Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 230402
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 229602
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 460-0001
        • Duplicate_NHO Nagoya Medical Center /ID# 230678
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Aichi Cancer Center Hospital /ID# 230134
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Fujita Health University Hospital /ID# 264541
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East /ID# 232423
    • Ehime
      • Matsuyama, Ehime, Japan, 790-8524
        • Matsuyama Red Cross Hospital /ID# 251866
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center /ID# 252245
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital /ID# 230136
    • Fukushima
      • Fukushima, Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital /ID# 251839
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital /ID# 231443
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Kobe City Medical Center General Hospital /ID# 251945
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-8520
        • Kagoshima University Hospital /ID# 232251
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Tokai University Hospital /ID# 252135
      • Sagamihara-shi, Kanagawa, Japan, 252-0375
        • Kitasato University Hospital /ID# 264668
    • Kyoto
      • Kyoto, Kyoto, Japan, 606-8507
        • Kyoto University Hospital /ID# 231156
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Mie University Hospital /ID# 251944
    • Miyagi
      • Sendai, Miyagi, Japan, 9808574
        • Tohoku University Hospital /ID# 232303
    • Nagano
      • Matsumoto-shi, Nagano, Japan, 390-8621
        • Shinshu University Hospital /ID# 252246
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8558
        • Okayama University Hospital /ID# 232009
    • Osaka
      • Osaka, Osaka, Japan, 534-0021
        • Osaka City General Hospital /ID# 264670
      • Sakai-shi, Osaka, Japan, 590-0197
        • Kindai University Hospital /ID# 232152
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital /ID# 230004
      • Koto-ku, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital Of JFCR /ID# 230271
    • Yamagata
      • Yamagata, Yamagata, Japan, 990-9585
        • Yamagata University Hospital /ID# 230005
    • Yamanashi
      • Kofu, Yamanashi, Japan, 400-0027
        • Yamanashi Prefectural Central Hospital /ID# 263715
  • Netherlands
      • Deventer, Netherlands, 7416 SE
        • Deventer Ziekenhuis /ID# 247853
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen /ID# 247741
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6532 SZ
        • Canisius-Wilhelmina Ziekenhuis /ID# 248138
    • North Brabant
      • Breda, North Brabant, Netherlands, 4818 CK
        • Amphia Ziekenhuis /ID# 247739
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1091 AC
        • Olvg /Id# 247899
      • Hoorn, North Holland, Netherlands, 1624 NP
        • Dijklander Ziekenhuis /ID# 248993
    • Overijssel
      • Enschede, Overijssel, Netherlands, 7512 KZ
        • Medisch Spectrum Twente /ID# 247854
    • South Holland
      • Dordrecht, South Holland, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis /ID# 247740
      • Leiden, South Holland, Netherlands, 2333 ZA
        • Leids Universitair Medisch Centrum /ID# 247742
      • Rotterdam, South Holland, Netherlands, 3045 PM
        • Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 248139
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3435 CM
        • St. Antonius Ziekenhuis /ID# 248644
    • Zeeland
      • Goes, Zeeland, Netherlands, 4462 RA
        • Admiraal de Ruyter Ziekenhuis /ID# 247692
  • New Zealand
    • Auckland
      • Papatoetoe, Auckland, New Zealand, 2025
        • Aotearoa Clinical Trials /ID# 228509
      • Takapuna, Auckland, New Zealand, 0622
        • North Shore Hospital /ID# 228508
    • Manawatu-Wanganui
      • Palmerston North, Manawatu-Wanganui, New Zealand, 4442
        • Palmerston North Hospital /ID# 232352
  • Poland
    • Greater Poland Voivodeship
      • Piła, Greater Poland Voivodeship, Poland, 64-920
        • ARS-MEDICAL Sp. z o.o. /ID# 229601
      • Skórzewo, Greater Poland Voivodeship, Poland, 60-185
        • Aidport Sp. z o.o. /ID# 229299
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Pratia MCM Krakow /ID# 229121
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-519
        • Szpitale Pomorskie Sp. z o.o /ID# 229122
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 229362
  • Puerto Rico
      • Manati, Puerto Rico, 00674
        • Hematology and Oncology Institute /ID# 230056
      • Rio Piedras, Puerto Rico, 00935
        • Pan American Center for Oncology Trials, LLC /ID# 230055
      • San Juan, Puerto Rico, 00918
        • Auxilio Mutuo Cancer Center /ID# 248721
  • Slovakia
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 833 10
        • Narodny onkologicky ustav /ID# 239510
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1864
        • Wits Clinical Research /ID# 228895
      • Pretoria, Gauteng, South Africa, 0044
        • Alberts Cellular Therapy /ID# 228896
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • University of Cape Town /ID# 228900
      • Kuils River, Western Cape, South Africa, 7580
        • Haemalife Inc. /ID# 243392
  • South Korea
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, South Korea, 47392
        • Inje University - Busan Paik Hospital /ID# 230293
      • Busan, Busan Gwang Yeogsi, South Korea, 49201
        • Dong-A University Medical Center /ID# 228638
      • Busan, Busan Gwang Yeogsi, South Korea, 49241
        • Pusan National University Hospital /ID# 229798
    • Gyeonggido
      • Seongnam-si, Gyeonggido, South Korea, 13620
        • Seoul National University Bundang Hospital /ID# 228448
    • Gyeongsangbuk-do
      • Daegu, Gyeongsangbuk-do, South Korea, 42601
        • Keimyung University Dongsan Hospital /ID# 229800
    • Jeonrabugdo
      • Jeonju, Jeonrabugdo, South Korea, 54907
        • Jeonbuk National University Hospital /ID# 228908
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital /ID# 228446
      • Seoul, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center /ID# 228444
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Samsung Medical Center /ID# 228445
      • Seoul, Seoul Teugbyeolsi, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 228447
  • Spain
      • Barcelona, Spain, 08003
        • Hospital Parc de Salut del Mar /ID# 228106
      • Barcelona, Spain, 08041
        • Hospital Santa Creu i Sant Pau /ID# 229859
      • Cáceres, Spain, 10003
        • Hospital San Pedro de Alcantara /ID# 248845
      • Madrid, Spain, 28027
        • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 229157
      • Madrid, Spain, 28033
        • MD Anderson Madrid /ID# 229860
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal /ID# 228113
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz /ID# 228110
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre /ID# 228109
      • Salamanca, Spain, 37711
        • Hospital Universitario de Salamanca /ID# 228117
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio /ID# 228118
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Instituto Catalan de Oncologia (ICO) Badalona /ID# 228108
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 228107
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla /ID# 228984
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia /ID# 228122
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universidad de Navarra - Pamplona /ID# 228116
  • Sweden
    • Norrbotten County
      • Luleå, Norrbotten County, Sweden, 971 80
        • Sunderby sjukhus /ID# 228165
    • Västra Götaland County
      • Borås, Västra Götaland County, Sweden, 501 82
        • Sodra Alvsborgs sjukhus /ID# 228886
    • Östergötland County
      • Linköping, Östergötland County, Sweden, 581 85
        • Linkoping University Hospital /ID# 233520
  • Switzerland
    • Canton Ticino
      • Bellinzona, Canton Ticino, Switzerland, 6500
        • EOC Ospedale Regionale di Bellinzona e Valli /ID# 228922
    • Canton of Aargau
      • Aarau, Canton of Aargau, Switzerland, 5001
        • Kantonsspital Aarau AG /ID# 229113
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen /ID# 229117
    • Kanton Graubünden
      • Chur, Kanton Graubünden, Switzerland, 7000
        • Kantonsspital Graubünden /ID# 253862
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital /ID# 227379
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital /ID# 227383
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital /ID# 227381
    • Kaohsiung
      • Kaohsiung City, Kaohsiung, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital /ID# 227384
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06620
        • Ankara Universitesi Fakultesi /ID# 227790
      • Antalya, Turkey (Türkiye), 07059
        • Akdeniz Universitesi Tip Fakul /ID# 227791
      • Diyarbakır, Turkey (Türkiye), 21200
        • Dicle Universitesi Tip /ID# 230087
      • Istanbul, Turkey (Türkiye), 34098
        • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 248202
      • Istanbul, Turkey (Türkiye), 34200
        • Istanbul Florence Nightingale Hastanesi /ID# 229546
      • Istanbul, Turkey (Türkiye), 34899
        • Duplicate_Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 227855
      • Izmir, Turkey (Türkiye), 35040
        • Ege University Medical Faculty /ID# 227792
      • Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli University Med Faculty /ID# 227854
      • Samsun, Turkey (Türkiye), 55200
        • Ondokuz mayis University Facul /ID# 227794
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust /ID# 230043
      • Colchester, United Kingdom, CO4 5JL
        • East Suffolk and North Essex NHS Foundation Trust /ID# 230040
      • Liverpool, United Kingdom, L7 8YA
        • Clatterbridge Cancer Centre - Liverpool /ID# 230036
      • Manchester, United Kingdom, M20 4BX
        • The Christie Hospital /ID# 230124
      • Newcastle upon Tyne, United Kingdom, NE3 3HD
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 230123
      • Portsmouth, United Kingdom, PO6 3LY
        • Portsmouth Hospitals University NHS Trust /ID# 230044
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Derriford Hospital and the Royal Eye Infirmary /ID# 230038
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • Gartnavel General Hospital /ID# 230027
    • Greater London
      • London, Greater London, United Kingdom, E1 2ES
        • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 230028
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust /ID# 230035
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust /ID# 230471
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • The University of Arizona Cancer Center - North Campus /ID# 228862
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences /ID# 227198
    • California
      • Berkeley, California, United States, 94705
        • Alta Bates Summit Medical Center for Research /ID# 229428
      • Beverly Hills, California, United States, 90211
        • Beverly Hills Cancer Center /ID# 231535
      • Long Beach, California, United States, 90806-1701
        • Long Beach Memorial Medical Ct /ID# 228997
      • Los Angeles, California, United States, 90033
        • University of Southern California /ID# 227195
      • Los Angeles, California, United States, 90067
        • Valkyrie Clinical Trials /ID# 268502
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Duplicate_Emory University /ID# 227299
    • Hawaii
      • Honolulu, Hawaii, United States, 96813-4920
        • Hawaii Cancer Care - Waterfront Plaza /ID# 262448
    • Illinois
      • Chicago, Illinois, United States, 60611-2927
        • Northwestern University Feinberg School of Medicine /ID# 227248
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Goshen Center for Cancer Care /ID# 227189
      • Indianapolis, Indiana, United States, 46250-2042
        • Community Health Network, Inc. /ID# 259756
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady Of The Lake Regional Medical Center /ID# 251393
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore /ID# 227191
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital /ID# 245233
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial Medical Center /ID# 227323
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital /ID# 227250
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • St. Luke's Hospital - Chesterfield /ID# 247817
    • Montana
      • Billings, Montana, United States, 59102
        • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 251220
    • New Jersey
      • Morristown, New Jersey, United States, 07960-6136
        • Morristown Medical Center /ID# 231427
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute /ID# 239128
      • Mineola, New York, United States, 11501
        • NYU Langone Hospital - Long Island /ID# 253343
      • New York, New York, United States, 10016
        • NYU Laura and Isaac Perlmutter Cancer Center /ID# 227322
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai /ID# 227181
      • New York, New York, United States, 10065-6007
        • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • East Carolina University - Brody School of Medicine /ID# 227192
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104-5418
        • University of Oklahoma, Stephenson Cancer Center /ID# 227325
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Sammons Cancer Center /ID# 261584
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Northeast Texas /ID# 265890
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • Intermountain Healthcare LDS Hospital /ID# 259948
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University Medical Center Main Hospital /ID# 227211

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.

  • Participant has:

    • Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
    • >= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI.
  • 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:

  • Documented refractoriness to lenalidomide.
  • Have lenalidomide exposure within 12 months prior to randomization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epcoritamab Dose A in Combination With R2
Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
Drug: Epcoritamab
Subcutaneous Injection
Other Names:
  • GEN3013
Drug: Rituximab
Intravenous Infusion
Drug: Lenalidomide
Oral Capsules
Active Comparator: Lenalidomide and Rituximab (R2)
Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
Drug: Rituximab
Intravenous Infusion
Drug: Lenalidomide
Oral Capsules
Experimental: Epcoritamab Dose B in Combination With R2
Participants will receive epcoritamab Dose B in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days). Enrollment is closed for this arm.
Drug: Epcoritamab
Subcutaneous Injection
Other Names:
  • GEN3013
Drug: Rituximab
Intravenous Infusion
Drug: Lenalidomide
Oral Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Best Overall Response (BOR)
Time Frame: Up to approximately 2 years and 3 months
BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria, as assessed by an IRC.
Up to approximately 2 years and 3 months
Progression-Free Survival (PFS)
Time Frame: Up to approximately 2 years and 3 months
PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by independent review committee (IRC) or death (whichever occurs first).
Up to approximately 2 years and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 8 years from randomization
Overall survival is defined as the duration from the date of randomization to the date of the participant's death.
Up to approximately 8 years from randomization
Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity
Time Frame: Up to approximately 5 years
MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of subsequent anti-lymphoma therapy.
Up to approximately 5 years
Percentage of Participants Achieving CR
Time Frame: Up to approximately 5 years
Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy.
Up to approximately 5 years
Change in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
Time Frame: Up to approximately 8 years
The objective of the FACT-Lym patient-reported outcome (PRO) is to address health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Like-type scale, with a higher score signifying a higher quality of life.
Up to approximately 8 years
PFS as Assessed by Investigator
Time Frame: Up to approximately 5 years
PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by investigator or death (whichever occurs first).
Up to approximately 5 years
Percentage of Participants Achieving BOR as Assessed by Investigator
Time Frame: Up to approximately 5 years
BOR is defined as CR PR, determined by Lugano criteria, as assessed by an investigator.
Up to approximately 5 years
Percentage of Participants Achieving CR as Assessed by Investigator
Time Frame: Up to approximately 5 years
Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the investigator prior to the initiation of subsequent anti-lymphoma therapy.
Up to approximately 5 years
Duration of Response (DOR)
Time Frame: Up to approximately 8 years
DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.
Up to approximately 8 years
Duration of Complete Response (DOCR)
Time Frame: Up to approximately 8 years
DOR is defined as the time from the first occurrence of CR to disease progression or death, whichever occurs first.
Up to approximately 8 years
Time to Progression (TTP)
Time Frame: Up to approximately 8 years
Time to progression is defined as the number of days from the date of study drug start to the date of the first documented disease progression or relapse.
Up to approximately 8 years
Time to Next Anti-Lymphoma Treatment (TTNLT)
Time Frame: Up to approximately 8 years
Time to next anti-lymphoma treatment is defined as the number of days from the date of the first documented disease progression or relapse to the date of next anti-lymphoma treatment.
Up to approximately 8 years
Percentage of Participants Achieving CR at the End of Treatment
Time Frame: Up to approximately 5 years
Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy.
Up to approximately 5 years
Time to Response (TTR)
Time Frame: Up to approximately 8 years
Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.
Up to approximately 8 years
Time to Complete Response (TTCR)
Time Frame: Up to approximately 8 years
Time to complete response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.
Up to approximately 8 years
Event-Free Survival (EFS)
Time Frame: Up to approximately 8 years
EFS is defined as the duration from randomization to disease progression determined by Lugano criteria as assessed by the investigator, initiation of any non-protocol-specified new anti-lymphoma therapy for any reason, or death (whichever occurs first).
Up to approximately 8 years
Time to next anti-lymphoma treatment (TTNLT)
Time Frame: Up to approximately 8 years
Up to approximately 8 years
Change in Patient's Global Impression of Severity (PGIS)
Time Frame: Up to approximately 8 years
PGIS is a self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity. Participants rate their lymphoma symptoms severity as none, mild, moderate, severe, or very severe.
Up to approximately 8 years
Change in Patient's Global Impression of Change (PGIC)
Time Frame: Up to approximately 8 years
PGIS is a self-report measure PGIC reflects a participant's belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement since start of treatment. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
Up to approximately 8 years
Change in EuroQol 5-Dimension Questionnaire, 5-level (EQ-5D-5L)
Time Frame: Up to approximately 8 years
The EQ-5D-5L descriptive system measures health status and comprises 5 health aspects including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each parameter has 5 response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. This instrument will not be administered during the Survival Follow-Up.
Up to approximately 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genmab

Collaborators

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2022

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

June 3, 2022

First Submitted That Met QC Criteria

June 3, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M20-638
  • 2023-505628-67 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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