AzTrials
AzTrials

Follicular Lymphoma (FL)Phase 3EPCORE FL-1NCT05409066

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

A Phase 3 study testing Epcoritamab, Rituximab and Lenalidomide in people with Follicular Lymphoma (FL), run by Genmab at 273 sites in 30 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma (FL)
What is being tested?
Epcoritamab, Rituximab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
549 participants
Where
273 sitesin 30 countries
Study dates
20 Sep 2022to Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

273 sites in 30 countries.

273 sites in 30 countries

United States31 sites

  • Duplicate_Emory University /ID# 227299

    Atlanta, Georgia, 30322-1013

  • University of Maryland, Baltimore /ID# 227191

    Baltimore, Maryland, 21201

  • Our Lady Of The Lake Regional Medical Center /ID# 251393

    Baton Rouge, Louisiana, 70808

  • Alta Bates Summit Medical Center for Research /ID# 229428

    Berkeley, California, 94705

  • Beverly Hills Cancer Center /ID# 231535

    Beverly Hills, California, 90211

  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 251220

    Billings, Montana, 59102

  • Massachusetts General Hospital /ID# 245233

    Boston, Massachusetts, 02114

  • Roswell Park Cancer Institute /ID# 239128

    Buffalo, New York, 14263

  • St. Luke's Hospital - Chesterfield /ID# 247817

    Chesterfield, Missouri, 63017

  • Northwestern University Feinberg School of Medicine /ID# 227248

    Chicago, Illinois, 60611-2927

  • Baylor Sammons Cancer Center /ID# 261584

    Dallas, Texas, 75246

  • Henry Ford Hospital /ID# 227250

    Detroit, Michigan, 48202

  • Goshen Center for Cancer Care /ID# 227189

    Goshen, Indiana, 46526

  • East Carolina University - Brody School of Medicine /ID# 227192

    Greenville, North Carolina, 27834

  • Hawaii Cancer Care - Waterfront Plaza /ID# 262448

    Honolulu, Hawaii, 96813-4920

  • Community Health Network, Inc. /ID# 259756

    Indianapolis, Indiana, 46250-2042

  • University of Arkansas for Medical Sciences /ID# 227198

    Little Rock, Arkansas, 72205

  • Long Beach Memorial Medical Ct /ID# 228997

    Long Beach, California, 90806-1701

  • University of Southern California /ID# 227195

    Los Angeles, California, 90033

  • Valkyrie Clinical Trials /ID# 268502

    Los Angeles, California, 90067

  • NYU Langone Hospital - Long Island /ID# 253343

    Mineola, New York, 11501

  • Morristown Medical Center /ID# 231427

    Morristown, New Jersey, 07960-6136

  • NYU Laura and Isaac Perlmutter Cancer Center /ID# 227322

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai /ID# 227181

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193

    New York, New York, 10065-6007

  • University of Oklahoma, Stephenson Cancer Center /ID# 227325

    Oklahoma City, Oklahoma, 73104-5418

  • Virginia Commonwealth University Medical Center Main Hospital /ID# 227211

    Richmond, Virginia, 23219

  • Intermountain Healthcare LDS Hospital /ID# 259948

    Salt Lake City, Utah, 84143

  • The University of Arizona Cancer Center - North Campus /ID# 228862

    Tucson, Arizona, 85719

  • Texas Oncology - Northeast Texas /ID# 265890

    Tyler, Texas, 75702

  • UMass Memorial Medical Center /ID# 227323

    Worcester, Massachusetts, 01605

Other trials in United States

China24 sites

  • Peking University First Hospital /ID# 250517

    Beijing, Beijing Municipality, 100034

  • Peking University Third Hospital /ID# 230885

    Beijing, Beijing Municipality, 100191

  • Hunan Cancer Hospital /ID# 232153

    Changsha, Hunan, 410006

  • Fujian Medical University Union Hospital /ID# 233919

    Fuzhou, Fujian, 350001

  • Sun Yat-Sen University Cancer Center /ID# 231463

    Guangzhou, Guangdong, 510060

  • Guangdong Provincial Peoples Hospital（Huifu Campus） /ID# 232512

    Guangzhou, Guangdong, 510120

  • Nanfang Hospital of Southern Medical University /ID# 230383

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230390

    Hangzhou, Zhejiang, 310003

  • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 231250

    Hangzhou, Zhejiang, 310009

  • Zhejiang Cancer hospital /ID# 231389

    Hangzhou, Zhejiang, 310022

  • Yunnan Cancer Hospital /ID# 232062

    Kunming, Yunnan, 650118

  • The First Affiliated Hospital of Nanchang University /ID# 231047

    Nanchang, Jiangxi, 330006

  • Jiangxi Provincial Cancer Hospital /ID# 232507

    Nanchang, Jiangxi, 330029

  • Fudan University Cancer Hospital /ID# 250475

    Shanghai, Shanghai Municipality, 200032

  • First Affiliated Hospital of China Medical University /ID# 232509

    Shenyang, Liaoning, 110001

  • Fourth Hospital of Hebei Medical University /ID# 238657

    Shijiazhuang, Hebei, 050011

  • The First Affiliated Hospital of Soochow University /ID# 232511

    Suzhou, Jiangsu, 215006

  • Tianjin Cancer Hospital /ID# 230876

    Tianjin, Tianjin Municipality, 300000

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234153

    Wuhan, Hubei, 430048

  • Hubei Cancer Hospital /ID# 232255

    Wuhan, Hubei, 430079

  • Xijing Hospital /ID# 238650

    Xi'an, Shaanxi, 710032

  • The First Affiliated Hospital of Xiamen University /ID# 238427

    Xiamen, Fujian, 361003

  • The Affiliated Hospital of Xuzhou Medical College /ID# 232513

    Xuzhou, Jiangsu, 221006

  • Henan Cancer Hospital /ID# 230459

    Zhengzhou, Henan, 450008

Other trials in China

Japan24 sites

  • National Cancer Center Hospital /ID# 230004

    Chuo-ku, Tokyo, 104-0045

  • National Hospital Organization Kyushu Cancer Center /ID# 252245

    Fukuoka, Fukuoka, 811-1395

  • Kyushu University Hospital /ID# 230136

    Fukuoka, Fukuoka, 812-8582

  • Fukushima Medical University Hospital /ID# 251839

    Fukushima, Fukushima, 960-1295

  • Tokai University Hospital /ID# 252135

    Isehara, Kanagawa, 259-1193

  • Kagoshima University Hospital /ID# 232251

    Kagoshima, Kagoshima-ken, 890-8520

  • National Cancer Center Hospital East /ID# 232423

    Kashiwa-shi, Chiba, 277-8577

  • Kobe City Medical Center General Hospital /ID# 251945

    Kobe, Hyōgo, 650-0047

  • Yamanashi Prefectural Central Hospital /ID# 263715

    Kofu, Yamanashi, 400-0027

  • The Cancer Institute Hospital Of JFCR /ID# 230271

    Koto-ku, Tokyo, 135-8550

  • Kyoto University Hospital /ID# 231156

    Kyoto, Kyoto, 606-8507

  • Shinshu University Hospital /ID# 252246

    Matsumoto-shi, Nagano, 390-8621

  • Matsuyama Red Cross Hospital /ID# 251866

    Matsuyama, Ehime, 790-8524

  • Duplicate_NHO Nagoya Medical Center /ID# 230678

    Nagoya, Aichi-ken, 460-0001

  • Aichi Cancer Center Hospital /ID# 230134

    Nagoya, Aichi-ken, 464-8681

  • Okayama University Hospital /ID# 232009

    Okayama, Okayama-ken, 700-8558

  • Osaka City General Hospital /ID# 264670

    Osaka, Osaka, 534-0021

  • Kitasato University Hospital /ID# 264668

    Sagamihara-shi, Kanagawa, 252-0375

  • Kindai University Hospital /ID# 232152

    Sakai-shi, Osaka, 590-0197

  • Hokkaido University Hospital /ID# 231443

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital /ID# 232303

    Sendai, Miyagi, 9808574

  • Fujita Health University Hospital /ID# 264541

    Toyoake, Aichi-ken, 470-1192

  • Mie University Hospital /ID# 251944

    Tsu, Mie-ken, 514-8507

  • Yamagata University Hospital /ID# 230005

    Yamagata, Yamagata, 990-9585

Other trials in Japan

France19 sites

  • CHU de CAEN - Hopital de la Cote de Nacre /ID# 245929

    Caen, Calvados, 14033

  • CHU Clermont-Ferrand /ID# 238676

    Clermont, Auvergne-Rhône-Alpes, 63100

  • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 230358

    Créteil, Paris, 94010

  • CHU Dijon /ID# 230354

    Dijon, Cote-d Or, 21000

  • Centre Hospitalier Departemental Vendee (Chd Vendee) /ID# 234095

    La Roche-sur-Yon, Vendee, 85925

  • CHRU Lille - Hopital Claude Huriez /ID# 230353

    Lille, Nord, 59037

  • CHU Limoges - Dupuytren 1 /ID# 231450

    Limoges, Franche-Comte, 87042

  • Centre Leon Berard /ID# 230348

    Lyon, Rhone, 69373

  • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 245928

    Nantes, Pays de la Loire Region, 44000

  • CHU NIMES - Hopital Caremeau /ID# 230351

    Nîmes, Gard, 30029

  • Hôpital Saint-Louis /ID# 232067

    Paris, 75010

  • Hopital Pitie Salpetriere /ID# 230360

    Paris, Île-de-France Region, 75013

  • Centre Hospitalier Universitaire de Bordeaux /ID# 230347

    Pessac, New Aquitaine, 33604

  • HCL - Hopital Lyon Sud /ID# 231449

    Pierre-Bénite, Rhone, 69495

  • CHU Poitiers - La miletrie /ID# 230357

    Poitiers, Vienne, 86000

  • CHU Reims - Hôpital Robert Debre /ID# 248710

    Reims, Marne, 51092

  • CHU de Rennes - PONTCHAILLOU /ID# 230356

    Rennes, Brittany Region, 35000

  • IUCT Oncopole /ID# 233486

    Toulouse, Occitanie, 31059

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 241595

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511

Other trials in France

Spain15 sites

  • Instituto Catalan de Oncologia (ICO) Badalona /ID# 228108

    Badalona, Barcelona, 08916

  • Hospital Parc de Salut del Mar /ID# 228106

    Barcelona, 08003

  • Hospital Santa Creu i Sant Pau /ID# 229859

    Barcelona, 08041

  • Hospital San Pedro de Alcantara /ID# 248845

    Cáceres, 10003

  • Hospital Universitario Reina Sofia /ID# 228122

    Córdoba, Cordoba, 14004

  • Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 228107

    L'Hospitalet de Llobregat, Barcelona, 08907

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 229157

    Madrid, 28027

  • MD Anderson Madrid /ID# 229860

    Madrid, 28033

  • Hospital Universitario Ramon y Cajal /ID# 228113

    Madrid, 28034

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 228110

    Madrid, 28040

  • Hospital Universitario 12 de Octubre /ID# 228109

    Madrid, 28041

  • Clinica Universidad de Navarra - Pamplona /ID# 228116

    Pamplona, Navarre, 31008

  • Hospital Universitario de Salamanca /ID# 228117

    Salamanca, 37711

  • Hospital Universitario Marques de Valdecilla /ID# 228984

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio /ID# 228118

    Seville, 41013

Other trials in Spain

Germany14 sites

  • Sozialstiftung Bamberg /ID# 229184

    Bamberg, 96049

  • Helios Klinikum Berlin-Buch /ID# 229178

    Berlin, 13125

  • Universitaetsklinikum Bonn /ID# 249401

    Bonn, North Rhine-Westphalia, 53127

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 229754

    Dresden, Saxony, 01307

  • Universitaetsklinikum Essen /ID# 229180

    Essen, 45147

  • Universitaetsklinikum Giessen /ID# 234245

    Giessen, Hesse, 35392

  • Universitaetsmedizin Goettingen /ID# 230411

    Göttingen, Lower Saxony, 37075

  • Universitaetsklinikum Jena /ID# 232064

    Jena, Thuringia, 07747

  • Klinikum Kassel /ID# 229185

    Kassel, Hesse, 34125

  • Universitaetsklinikum Leipzig /ID# 242907

    Leipzig, Saxony, 04103

  • Otto-von-Guericke-Universitaet /ID# 230144

    Magdeburg, Saxony-Anhalt, 39120

  • Klinikum Mutterhaus der Borromäerinnen /ID# 232354

    Trier, 54290

  • Universitaetsklinikum Tuebingen /ID# 229663

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Wuerzburg /ID# 229278

    Würzburg, Bavaria, 97080

Other trials in Germany

Italy14 sites

  • Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Aless /ID# 227401

    Alessandria, 15100

  • Duplicate_Centro di Riferimento Oncologico /ID# 227395

    Aviano, Pordenone, 33081

  • Duplicate_I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 227400

    Bari, 70124

  • ASST degli Spedali Civili di Brescia /ID# 227397

    Brescia, 25123

  • Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 229602

    Candiolo, Torino, 10060

  • IRCCS Ospedale San Raffaele /ID# 228669

    Milan, Milano, 20132

  • Istituto Europeo Di Oncologia /ID# 227396

    Milan, Milano, 20141

  • Duplicate_Azienda Ospedaliera Universitaria Federico II /ID# 230403

    Naples, 80131

  • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 227399

    Novara, 28100

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 227402

    Palermo, 90146

  • Ospedale Santa Maria Delle Croci /ID# 227394

    Ravenna, 48121

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 230402

    Rome, Roma, 00168

  • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 228458

    San Giovanni Rotondo, Foggia, 71013

  • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229820

    Turin, Piedmont, 10126

Other trials in Italy

Netherlands12 sites

  • Olvg /Id# 247899

    Amsterdam, North Holland, 1091 AC

  • Amphia Ziekenhuis /ID# 247739

    Breda, North Brabant, 4818 CK

  • Deventer Ziekenhuis /ID# 247853

    Deventer, 7416 SE

  • Albert Schweitzer Ziekenhuis /ID# 247740

    Dordrecht, South Holland, 3318 AT

  • Medisch Spectrum Twente /ID# 247854

    Enschede, Overijssel, 7512 KZ

  • Admiraal de Ruyter Ziekenhuis /ID# 247692

    Goes, Zeeland, 4462 RA

  • Universitair Medisch Centrum Groningen /ID# 247741

    Groningen, 9713 GZ

  • Dijklander Ziekenhuis /ID# 248993

    Hoorn, North Holland, 1624 NP

  • Leids Universitair Medisch Centrum /ID# 247742

    Leiden, South Holland, 2333 ZA

  • St. Antonius Ziekenhuis /ID# 248644

    Nieuwegein, Utrecht, 3435 CM

  • Canisius-Wilhelmina Ziekenhuis /ID# 248138

    Nijmegen, Gelderland, 6532 SZ

  • Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 248139

    Rotterdam, South Holland, 3045 PM

Other trials in Netherlands

United Kingdom11 sites

  • University Hospitals Birmingham NHS Foundation Trust /ID# 230043

    Birmingham, B15 2TH

  • East Suffolk and North Essex NHS Foundation Trust /ID# 230040

    Colchester, CO4 5JL

  • Gartnavel General Hospital /ID# 230027

    Glasgow, Glasgow City, G12 0YN

  • Leeds Teaching Hospitals NHS Trust /ID# 230471

    Leeds, West Yorkshire, LS9 7TF

  • Clatterbridge Cancer Centre - Liverpool /ID# 230036

    Liverpool, L7 8YA

  • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 230028

    London, Greater London, E1 2ES

  • The Christie Hospital /ID# 230124

    Manchester, M20 4BX

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 230123

    Newcastle upon Tyne, NE3 3HD

  • Oxford University Hospitals NHS Foundation Trust /ID# 230035

    Oxford, Oxfordshire, OX3 9DU

  • Derriford Hospital and the Royal Eye Infirmary /ID# 230038

    Plymouth, Devon, PL6 8DH

  • Portsmouth Hospitals University NHS Trust /ID# 230044

    Portsmouth, PO6 3LY

Other trials in United Kingdom

South Korea10 sites

  • Inje University - Busan Paik Hospital /ID# 230293

    Busan, Busan Gwang Yeogsi, 47392

  • Dong-A University Medical Center /ID# 228638

    Busan, Busan Gwang Yeogsi, 49201

  • Pusan National University Hospital /ID# 229798

    Busan, Busan Gwang Yeogsi, 49241

  • Keimyung University Dongsan Hospital /ID# 229800

    Daegu, Gyeongsangbuk-do, 42601

  • Jeonbuk National University Hospital /ID# 228908

    Jeonju, Jeonrabugdo, 54907

  • Seoul National University Bundang Hospital /ID# 228448

    Seongnam-si, Gyeonggido, 13620

  • Seoul National University Hospital /ID# 228446

    Seoul, Seoul Teugbyeolsi, 03080

  • Asan Medical Center /ID# 228444

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center /ID# 228445

    Seoul, Seoul Teugbyeolsi, 06351

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 228447

    Seoul, Seoul Teugbyeolsi, 06591

Other trials in South Korea

Brazil9 sites

  • Upeclin Fmb - Unesp /Id# 252912

    Botucatu, São Paulo, 18618-686

  • Hospital de Clinicas da Universidade Federal do Parana /ID# 228123

    Curitiba, Paraná, 80060-900

  • Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 228129

    Jaú, São Paulo, 17210-070

  • Instituto Nacional de Cancer (INCA) /ID# 228706

    Rio de Janeiro, 20231-050

  • Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 228130

    São Paulo, São Paulo, 01509-900

  • Real e Benemérita Associação Portuguesa de Beneficência /ID# 228121

    São Paulo, 01323-001

  • Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 252918

    São Paulo, 01401-002

  • Instituto de Assistencia Medica ao Servidor Publico Estadual /ID# 230182

    São Paulo, 04039-901

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 228127

    São Paulo, 05403-000

Other trials in Brazil

Turkey (Türkiye)9 sites

  • Ankara Universitesi Fakultesi /ID# 227790

    Ankara, 06620

  • Akdeniz Universitesi Tip Fakul /ID# 227791

    Antalya, 07059

  • Dicle Universitesi Tip /ID# 230087

    Diyarbakır, 21200

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 248202

    Istanbul, 34098

  • Istanbul Florence Nightingale Hastanesi /ID# 229546

    Istanbul, 34200

  • Duplicate_Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 227855

    Istanbul, 34899

  • Ege University Medical Faculty /ID# 227792

    Izmir, 35040

  • Kocaeli University Med Faculty /ID# 227854

    Kocaeli, 41380

  • Ondokuz mayis University Facul /ID# 227794

    Samsun, 55200

Other trials in Turkey (Türkiye)

Hungary8 sites

  • Semmelweis Egyetem /ID# 229291

    Budapest, 1085

  • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 229286

    Budapest, 1097

  • Orszagos Onkologiai Intezet /ID# 229292

    Budapest, 1122

  • Debreceni Egyetem-Klinikai Kozpont /ID# 229287

    Debrecen, Hajdú-Bihar, 4032

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246475

    Kaposvár, Somogy County, 7400

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 232203

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Szegedi Tudomanyegyetem /ID# 229289

    Szeged, 6720

  • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 229290

    Szombathely, Vas County, 9700

Other trials in Hungary

Australia7 sites

  • Royal Prince Alfred Hospital /ID# 239272

    Camperdown, New South Wales, 2050

  • Townsville University Hospital /ID# 231124

    Douglas, Queensland, 4814

  • Peninsula Private Hospital /ID# 238796

    Frankston, Victoria, 3199

  • Nepean Hospital /ID# 239093

    Kingswood, New South Wales, 2747

  • Fiona Stanley Hospital /ID# 231122

    Murdoch, Western Australia, 6150

  • Royal Perth Hospital /ID# 230456

    Perth, Western Australia, 6000

  • Hollywood Private Hospital /ID# 251789

    Perth, Western Australia, 6009

Other trials in Australia

Belgium7 sites

  • Institut Jules Bordet /ID# 254676

    Anderlecht, 1070

  • Uza /Id# 228521

    Edegem, Antwerpen, 2650

  • Hospital La Louviere Site Jolimont - Helora /ID# 228520

    La Louvière, Hainaut, 7100

  • Universitair Ziekenhuis Leuven /ID# 247780

    Leuven, Vlaams-Brabant, 3000

  • Groupe Sante CHC - Clinique du MontLegia /ID# 230415

    Liège, Liege, 4000

  • Vitaz /Id# 228525

    Sint-Niklaas, Oost-Vlaanderen, 9100

  • AZ Turnhout - Campus Sint-Elisabeth /ID# 231628

    Turnhout, 2300

Other trials in Belgium

Greece7 sites

  • General Hospital of Athens Laiko /ID# 226626

    Athens, Attica, 11527

  • Alexandra General Hospital /ID# 226632

    Athens, Attica, 11528

  • University General Hospital Attikon /ID# 226629

    Athens, Attica, 12462

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 226633

    Athens, 10676

  • University General Hospital of Ioannina /ID# 226628

    Ioannina, 45500

  • General University Hospital of Thessaloniki AXEPA /ID# 226630

    Thessaloniki, 54636

  • Theageneio Anticancer Hospital /ID# 226627

    Thessaloniki, 54639

Other trials in Greece

Israel7 sites

  • Rambam Health Care Campus /ID# 227849

    Haifa, 3109601

  • Hadassah /ID# 227846

    Jerusalem, Jerusalem, 91120

  • Rabin Medical Center. /ID# 228043

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 228322

    Ramat Gan, Tel Aviv, 5265601

  • ZIV Medical Center /ID# 232257

    Safed, Northern District, 13100

  • Tel Aviv Sourasky Medical Center /ID# 228529

    Tel Aviv, Tel Aviv, 6423906

  • Yitzhak Shamir Medical Center /ID# 228037

    Tsrifin, Central District, 70300

Other trials in Israel

Canada5 sites

  • Cross Cancer Institute /ID# 249080

    Edmonton, Alberta, T6G 1Z2

  • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229896

    Lévis, Quebec, G6V 3Z1

  • CHUQ- Hôpital de l'Enfant-Jesus /ID# 231537

    Québec, Quebec, G1J 1Z4

  • CISSSBSL -Hopital regional de Rimouski /ID# 229894

    Rimouski, Quebec, G5L 5T1

  • BC Cancer - Victoria /ID# 228850

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

Poland5 sites

  • Szpitale Pomorskie Sp. z o.o /ID# 229122

    Gdynia, Pomeranian Voivodeship, 81-519

  • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 229362

    Kielce, Świętokrzyskie Voivodeship, 25-734

  • Pratia MCM Krakow /ID# 229121

    Krakow, Lesser Poland Voivodeship, 30-727

  • ARS-MEDICAL Sp. z o.o. /ID# 229601

    Piła, Greater Poland Voivodeship, 64-920

  • Aidport Sp. z o.o. /ID# 229299

    Skórzewo, Greater Poland Voivodeship, 60-185

Other trials in Poland

Argentina4 sites

  • Fundaleu /Id# 229700

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1114

  • Duplicate_CEMIC /ID# 229697

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1431

  • Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 229701

    Córdoba, 5016

  • Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 232124

    Santa Fe, 3000

Other trials in Argentina

Czechia4 sites

  • Fakultní nemocnice Hradec Králové - Sokolská /ID# 228269

    Hradec Králové, Hradec Kralove, 500 05

  • Vseobecna Fakultni Nemocnice v Praze /ID# 228565

    Prague, Praha 17, 128 00

  • Fakultni nemocnice Kralovske Vinohrady /ID# 228564

    Prague, 100 34

  • Duplicate_Fakultni Nemocnice v Motole /ID# 228272

    Prague, 150 00

Other trials in Czechia

South Africa4 sites

  • University of Cape Town /ID# 228900

    Cape Town, Western Cape, 7925

  • Wits Clinical Research /ID# 228895

    Johannesburg, Gauteng, 1864

  • Haemalife Inc. /ID# 243392

    Kuils River, Western Cape, 7580

  • Alberts Cellular Therapy /ID# 228896

    Pretoria, Gauteng, 0044

Other trials in South Africa

Switzerland4 sites

  • Kantonsspital Aarau AG /ID# 229113

    Aarau, Canton of Aargau, 5001

  • EOC Ospedale Regionale di Bellinzona e Valli /ID# 228922

    Bellinzona, Canton Ticino, 6500

  • Kantonsspital Graubünden /ID# 253862

    Chur, Kanton Graubünden, 7000

  • Kantonsspital St. Gallen /ID# 229117

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

Taiwan4 sites

  • Kaohsiung Chang Gung Memorial Hospital /ID# 227384

    Kaohsiung City, Kaohsiung, 833

  • China Medical University Hospital /ID# 227379

    Taichung, 40447

  • Taichung Veterans General Hospital /ID# 227383

    Taichung, 40705

  • National Cheng Kung University Hospital /ID# 227381

    Tainan, 704

Other trials in Taiwan

Austria3 sites

  • Ordensklinikum Linz GmbH Elisabethinen /ID# 247510

    Linz, Upper Austria, 4010

  • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 228366

    Salzburg, 5020

  • Universitaetsklinikum St. Poelten /ID# 234015

    Sankt Pölten, Lower Austria, 3100

Other trials in Austria

New Zealand3 sites

  • Palmerston North Hospital /ID# 232352

    Palmerston North, Manawatu-Wanganui, 4442

  • Aotearoa Clinical Trials /ID# 228509

    Papatoetoe, Auckland, 2025

  • North Shore Hospital /ID# 228508

    Takapuna, Auckland, 0622

Other trials in New Zealand

Puerto Rico3 sites

  • Hematology and Oncology Institute /ID# 230056

    Manati, 00674

  • Pan American Center for Oncology Trials, LLC /ID# 230055

    Rio Piedras, 00935

  • Auxilio Mutuo Cancer Center /ID# 248721

    San Juan, 00918

Other trials in Puerto Rico

Sweden3 sites

  • Sodra Alvsborgs sjukhus /ID# 228886

    Borås, Västra Götaland County, 501 82

  • Linkoping University Hospital /ID# 233520

    Linköping, Östergötland County, 581 85

  • Sunderby sjukhus /ID# 228165

    Luleå, Norrbotten County, 971 80

Other trials in Sweden

Denmark2 sites

  • Regionshospitalet Godstrup /ID# 227466

    Herning, Central Jutland, 7400

  • Vejle Sygehus /ID# 227404

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

Slovakia1 site

  • Narodny onkologicky ustav /ID# 239510

    Bratislava, Bratislava Region, 833 10

Other trials in Slovakia

About this study

Official title: 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.

Read more

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.

Being tested
Epcoritamab, Rituximab, Lenalidomide
Keywords
Follicular Lymphoma (FL), Non-Hodgkin's lymphoma (NHL), Lymphoma, Cancer, Epcoritamab, Rituximab, Lenalidomide, EPCORE FL-1, EPCORE
Medical subject headings
Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05409066
Study groupRoleWhat they receive
Epcoritamab Dose A in Combination With R2ExperimentalParticipants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
Receives: Drug: Epcoritamab; Drug: Rituximab; Drug: Lenalidomide
Epcoritamab Dose B in Combination With R2ExperimentalParticipants 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.
Receives: Drug: Epcoritamab; Drug: Rituximab; Drug: Lenalidomide
Lenalidomide and Rituximab (R2)Active comparatorParticipants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
Receives: Drug: Rituximab; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Best Overall Response (BOR)

    BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria, as assessed by an IRC.

    Measured: Up to approximately 2 years and 3 months

  2. Progression-Free Survival (PFS)

    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).

    Measured: Up to approximately 2 years and 3 months

Secondary outcomes (19)

  1. Percentage of Participants Achieving CR

    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.

    Measured: Up to approximately 5 years

  2. Overall Survival (OS)

    Overall survival is defined as the duration from the date of randomization to the date of the participant's death.

    Measured: Up to approximately 8 years from randomization

  3. Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity

    MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of subsequent anti-lymphoma therapy.

    Measured: Up to approximately 5 years

  4. Change in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

    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.

    Measured: Up to approximately 8 years

  5. PFS as Assessed by Investigator

    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).

    Measured: Up to approximately 5 years

  6. Percentage of Participants Achieving BOR as Assessed by Investigator

    BOR is defined as CR PR, determined by Lugano criteria, as assessed by an investigator.

    Measured: Up to approximately 5 years

  7. Percentage of Participants Achieving CR as Assessed by Investigator

    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.

    Measured: Up to approximately 5 years

  8. Duration of Response (DOR)

    DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.

    Measured: Up to approximately 8 years

  9. Duration of Complete Response (DOCR)

    DOR is defined as the time from the first occurrence of CR to disease progression or death, whichever occurs first.

    Measured: Up to approximately 8 years

  10. Time to Progression (TTP)

    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.

    Measured: Up to approximately 8 years

  11. Time to Next Anti-Lymphoma Treatment (TTNLT)

    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.

    Measured: Up to approximately 8 years

  12. Percentage of Participants Achieving CR at the End of Treatment

    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.

    Measured: Up to approximately 5 years

  13. Time to Response (TTR)

    Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.

    Measured: Up to approximately 8 years

  14. Time to Complete Response (TTCR)

    Time to complete response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.

    Measured: Up to approximately 8 years

  15. Event-Free Survival (EFS)

    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).

    Measured: Up to approximately 8 years

  16. Time to next anti-lymphoma treatment (TTNLT)

    Measured: Up to approximately 8 years

  17. Change in Patient's Global Impression of Severity (PGIS)

    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.

    Measured: Up to approximately 8 years

  18. Change in Patient's Global Impression of Change (PGIC)

    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.

    Measured: Up to approximately 8 years

  19. Change in EuroQol 5-Dimension Questionnaire, 5-level (EQ-5D-5L)

    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.

    Measured: Up to approximately 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2022
  2. Study start20 Sep 2022
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
549 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05409066
Sponsor's protocol ID
M20-638
Other IDs
2023-505628-67, 2023
Acronym
EPCORE FL-1
Status last verified
Jul 2026
First submitted
3 Jun 2022
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Falchi L, Nijland M, Huang H, Linton KM, Seymour JF, Tao R, Kwiatek M, Costa A, Vassilakopoulos TP, Greil R, Jimenez-Ubieto A, Gangatharan SA, Benjamini O, Thieblemont C, Tucci A, Elinder-Camburn A, Illes A, Novak J, Pavlovsky MA, McDonald A, Yoon DH, Maruyama D, Sunkersett G, Mei JP, Mukherjee N, Zhu F, Alshreef A, Favaro E, Morschhauser F; EPCORE FL-1 Investigators. Epcoritamab, lenalidomide, and rituximab versus lenalidomide and rituximab for relapsed or refractory follicular lymphoma (EPCORE FL-1): a global, open-label, randomised, phase 3 trial. Lancet. 2026 Jan 10;407(10524):161-173. doi: 10.1016/S0140-6736(25)02360-8. Epub 2025 Dec 7.

    PubMed 41371238

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epcoritamab, Rituximab and Lenalidomide in people with Follicular Lymphoma (FL), run by Genmab at 273 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 273 sites in United States, China, Japan, France, Spain and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Best Overall Response (BOR) (time frame: Up to approximately 2 years and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05409066, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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