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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
Sponsor: Genmab
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. 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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
549
Start Date
2022-09-20
Completion Date
2029-12
Last Updated
2026-07-08
Healthy Volunteers
No
Conditions
Interventions
Epcoritamab
Subcutaneous Injection
Rituximab
Intravenous Infusion
Lenalidomide
Oral Capsules
Locations (273)
The University of Arizona Cancer Center - North Campus /ID# 228862
Tucson, Arizona, United States
University of Arkansas for Medical Sciences /ID# 227198
Little Rock, Arkansas, United States
Alta Bates Summit Medical Center for Research /ID# 229428
Berkeley, California, United States
Beverly Hills Cancer Center /ID# 231535
Beverly Hills, California, United States
Long Beach Memorial Medical Ct /ID# 228997
Long Beach, California, United States
University of Southern California /ID# 227195
Los Angeles, California, United States
Valkyrie Clinical Trials /ID# 268502
Los Angeles, California, United States
Duplicate_Emory University /ID# 227299
Atlanta, Georgia, United States
Hawaii Cancer Care - Waterfront Plaza /ID# 262448
Honolulu, Hawaii, United States
Northwestern University Feinberg School of Medicine /ID# 227248
Chicago, Illinois, United States
Goshen Center for Cancer Care /ID# 227189
Goshen, Indiana, United States
Community Health Network, Inc. /ID# 259756
Indianapolis, Indiana, United States
Our Lady Of The Lake Regional Medical Center /ID# 251393
Baton Rouge, Louisiana, United States
University of Maryland, Baltimore /ID# 227191
Baltimore, Maryland, United States
Massachusetts General Hospital /ID# 245233
Boston, Massachusetts, United States
UMass Memorial Medical Center /ID# 227323
Worcester, Massachusetts, United States
Henry Ford Hospital /ID# 227250
Detroit, Michigan, United States
St. Luke's Hospital - Chesterfield /ID# 247817
Chesterfield, Missouri, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 251220
Billings, Montana, United States
Morristown Medical Center /ID# 231427
Morristown, New Jersey, United States
Roswell Park Cancer Institute /ID# 239128
Buffalo, New York, United States
NYU Langone Hospital - Long Island /ID# 253343
Mineola, New York, United States
NYU Laura and Isaac Perlmutter Cancer Center /ID# 227322
New York, New York, United States
Icahn School of Medicine at Mount Sinai /ID# 227181
New York, New York, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193
New York, New York, United States
East Carolina University - Brody School of Medicine /ID# 227192
Greenville, North Carolina, United States
University of Oklahoma, Stephenson Cancer Center /ID# 227325
Oklahoma City, Oklahoma, United States
Baylor Sammons Cancer Center /ID# 261584
Dallas, Texas, United States
Texas Oncology - Northeast Texas /ID# 265890
Tyler, Texas, United States
Intermountain Healthcare LDS Hospital /ID# 259948
Salt Lake City, Utah, United States
Virginia Commonwealth University Medical Center Main Hospital /ID# 227211
Richmond, Virginia, United States
Fundaleu /Id# 229700
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Duplicate_CEMIC /ID# 229697
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 229701
Córdoba, Argentina
Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 232124
Santa Fe, Argentina
Royal Prince Alfred Hospital /ID# 239272
Camperdown, New South Wales, Australia
Nepean Hospital /ID# 239093
Kingswood, New South Wales, Australia
Townsville University Hospital /ID# 231124
Douglas, Queensland, Australia
Peninsula Private Hospital /ID# 238796
Frankston, Victoria, Australia
Fiona Stanley Hospital /ID# 231122
Murdoch, Western Australia, Australia
Royal Perth Hospital /ID# 230456
Perth, Western Australia, Australia
Hollywood Private Hospital /ID# 251789
Perth, Western Australia, Australia
Universitaetsklinikum St. Poelten /ID# 234015
Sankt Pölten, Lower Austria, Austria
Ordensklinikum Linz GmbH Elisabethinen /ID# 247510
Linz, Upper Austria, Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 228366
Salzburg, Austria
Uza /Id# 228521
Edegem, Antwerpen, Belgium
Hospital La Louviere Site Jolimont - Helora /ID# 228520
La Louvière, Hainaut, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 230415
Liège, Liege, Belgium
Vitaz /Id# 228525
Sint-Niklaas, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 247780
Leuven, Vlaams-Brabant, Belgium
Institut Jules Bordet /ID# 254676
Anderlecht, Belgium
AZ Turnhout - Campus Sint-Elisabeth /ID# 231628
Turnhout, Belgium
Hospital de Clinicas da Universidade Federal do Parana /ID# 228123
Curitiba, Paraná, Brazil
Upeclin Fmb - Unesp /Id# 252912
Botucatu, São Paulo, Brazil
Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 228129
Jaú, São Paulo, Brazil
Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 228130
São Paulo, São Paulo, Brazil
Instituto Nacional de Cancer (INCA) /ID# 228706
Rio de Janeiro, Brazil
Real e Benemérita Associação Portuguesa de Beneficência /ID# 228121
São Paulo, Brazil
Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 252918
São Paulo, Brazil
Instituto de Assistencia Medica ao Servidor Publico Estadual /ID# 230182
São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 228127
São Paulo, Brazil
Cross Cancer Institute /ID# 249080
Edmonton, Alberta, Canada
BC Cancer - Victoria /ID# 228850
Victoria, British Columbia, Canada
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229896
Lévis, Quebec, Canada
CHUQ- Hôpital de l'Enfant-Jesus /ID# 231537
Québec, Quebec, Canada
CISSSBSL -Hopital regional de Rimouski /ID# 229894
Rimouski, Quebec, Canada
Peking University First Hospital /ID# 250517
Beijing, Beijing Municipality, China
Peking University Third Hospital /ID# 230885
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital /ID# 233919
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University /ID# 238427
Xiamen, Fujian, China
Sun Yat-Sen University Cancer Center /ID# 231463
Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital(Huifu Campus) /ID# 232512
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 230383
Guangzhou, Guangdong, China
Fourth Hospital of Hebei Medical University /ID# 238657
Shijiazhuang, Hebei, China
Henan Cancer Hospital /ID# 230459
Zhengzhou, Henan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234153
Wuhan, Hubei, China
Hubei Cancer Hospital /ID# 232255
Wuhan, Hubei, China
Hunan Cancer Hospital /ID# 232153
Changsha, Hunan, China
The First Affiliated Hospital of Soochow University /ID# 232511
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College /ID# 232513
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 231047
Nanchang, Jiangxi, China
Jiangxi Provincial Cancer Hospital /ID# 232507
Nanchang, Jiangxi, China
First Affiliated Hospital of China Medical University /ID# 232509
Shenyang, Liaoning, China
Xijing Hospital /ID# 238650
Xi'an, Shaanxi, China
Fudan University Cancer Hospital /ID# 250475
Shanghai, Shanghai Municipality, China
Tianjin Cancer Hospital /ID# 230876
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital /ID# 232062
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230390
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 231250
Hangzhou, Zhejiang, China
Zhejiang Cancer hospital /ID# 231389
Hangzhou, Zhejiang, China
Fakultní nemocnice Hradec Králové - Sokolská /ID# 228269
Hradec Králové, Hradec Kralove, Czechia
Vseobecna Fakultni Nemocnice v Praze /ID# 228565
Prague, Praha 17, Czechia
Fakultni nemocnice Kralovske Vinohrady /ID# 228564
Prague, Czechia
Duplicate_Fakultni Nemocnice v Motole /ID# 228272
Prague, Czechia
Regionshospitalet Godstrup /ID# 227466
Herning, Central Jutland, Denmark
Vejle Sygehus /ID# 227404
Vejle, Region Syddanmark, Denmark
CHU Clermont-Ferrand /ID# 238676
Clermont, Auvergne-Rhône-Alpes, France
CHU de Rennes - PONTCHAILLOU /ID# 230356
Rennes, Brittany Region, France
CHU de CAEN - Hopital de la Cote de Nacre /ID# 245929
Caen, Calvados, France
CHU Dijon /ID# 230354
Dijon, Cote-d Or, France