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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 Previously Untreated 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 previously untreated 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 5 groups, called treatment arms. Each group receives a different treatment. Around 1095 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world. Participants will receive R2 (intravenous \[IV\] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) \[G-CHOP\]/ R-CHOP or G and IV infusion of bendamustine (Benda) \[G-Benda\]/R-Benda. The total treatment duration will be 120 weeks for all arms except A2, which is 24 weeks of treatment. 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, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1095
Start Date
2024-02-05
Completion Date
2037-11
Last Updated
2026-08-04
Healthy Volunteers
No
Conditions
Interventions
Epcoritamab
Subcutaneous (SC) Injection
Prednisone
Oral Tablet
Rituximab
Intravenous (IV) Infusion
Lenalidomide
Oral Capsule
Doxorubicin
IV Injection
Vincristine
IV Injection
Cyclophosphamide
IV Injection
Obinutuzumab
IV Infusion
Bendamustine
IV Infusion
Locations (266)
UCSF Fresno /ID# 264712
Fresno, California, United States
Scripps Mercy Hospital /ID# 265393
San Diego, California, United States
Sansum Clinic Research /ID# 261596
Santa Barbara, California, United States
Rocky Mountain Cancer Centers - Boulder /ID# 261203
Boulder, Colorado, United States
Christiana Care Health Service /ID# 261207
Newark, Delaware, United States
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445
Jacksonville, Florida, United States
Advent Health /ID# 261578
Orlando, Florida, United States
Orlando Health Cancer Institute /ID# 260983
Orlando, Florida, United States
Moffitt Cancer Center /ID# 259487
Tampa, Florida, United States
Beacon Cancer Care - Coeur d'Alene /ID# 260670
Coeur d'Alene, Idaho, United States
Northwestern Medicine - Northwestern Memorial Hospital /ID# 259814
Chicago, Illinois, United States
Cancer Care Specialists Of Central Illinois /ID# 272464
Decatur, Illinois, United States
Loyola University /ID# 259462
Maywood, Illinois, United States
Illinois Cancer Care, PC /ID# 261526
Peoria, Illinois, United States
Fort Wayne Medical Oncology and Hematology- South Office /ID# 259583
Fort Wayne, Indiana, United States
University of Iowa Health Care /ID# 262132
Des Moines, Iowa, United States
University of Louisville Hospital /ID# 260544
Louisville, Kentucky, United States
Norton Cancer Institute - St. Matthews /ID# 261076
Louisville, Kentucky, United States
New England Cancer Specialists - Westbrook /ID# 260672
Westbrook, Maine, United States
University of Maryland, Baltimore /ID# 259538
Baltimore, Maryland, United States
Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 259476
Bethesda, Maryland, United States
St. Luke's Hospital - Chesterfield /ID# 260489
Chesterfield, Missouri, United States
Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 260006
Billings, Montana, United States
Nebraska Cancer Specialists (NCS) - Regional Cancer Center - St Francis Location /ID# 262506
Grand Island, Nebraska, United States
Nebraska Hematology-Oncology /ID# 269692
Lincoln, Nebraska, United States
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 262505
Omaha, Nebraska, United States
University of Nebraska Medical Center /ID# 261996
Omaha, Nebraska, United States
University of New Mexico /ID# 261083
Albuquerque, New Mexico, United States
Presbyterian Kaseman Hospital /ID# 262451
Albuquerque, New Mexico, United States
Presbyterian Rust Medical Center /ID# 262447
Rio Rancho, New Mexico, United States
New York Oncology Hematology - Albany Cancer Center /ID# 261814
Albany, New York, United States
NYU Langone Hospital - Long Island /ID# 265531
Mineola, New York, United States
NYU Langone Medical Center /ID# 264518
New York, New York, United States
Icahn School of Medicine at Mount Sinai /ID# 259595
New York, New York, United States
New York Oncology Hematology /ID# 270208
Troy, New York, United States
Clinical Research Alliance - Westbury /ID# 261078
Westbury, New York, United States
Novant Health Presbyterian Medical Center /ID# 259740
Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center /ID# 259741
Winston-Salem, North Carolina, United States
Oncology Hematology Care, Inc - Blue Ash /ID# 261204
Cincinnati, Ohio, United States
Taylor Cancer Research Center /ID# 260488
Maumee, Ohio, United States
Oncology Associates of Oregon, P.C. /ID# 261816
Eugene, Oregon, United States
MUSC Hollings Cancer Center /ID# 259604
Charleston, South Carolina, United States
Prisma Health /ID# 259602
Greenville, South Carolina, United States
Sarah Cannon Research Institute - Tristar Centennial Medical Center /ID# 274985
Nashville, Tennessee, United States
Texas Oncology - Austin Midtown /ID# 261208
Austin, Texas, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 261206
Dallas, Texas, United States
MD Anderson Cancer Center /ID# 260984
Houston, Texas, United States
Oncology Consultants /ID# 268390
Houston, Texas, United States
Joe Arrington Cancer Research /ID# 260382
Lubbock, Texas, United States
Intermountain Healthcare LDS Hospital /ID# 259759
Salt Lake City, Utah, United States
Virginia Cancer Specialists - Fairfax /ID# 261205
Fairfax, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia /ID# 261592
Roanoke, Virginia, United States
Swedish Cancer Institute - Edmonds /ID# 266356
Edmonds, Washington, United States
Swedish Cancer Institute - Issaquah /ID# 266358
Issaquah, Washington, United States
Vista Oncology - East Olympia /ID# 261360
Olympia, Washington, United States
Virginia Mason Hospital and Medical Center /ID# 260549
Seattle, Washington, United States
Swedish Medical Center - Seattle /ID# 260370
Seattle, Washington, United States
Northwest Medical Specialties - Tacoma /ID# 262133
Tacoma, Washington, United States
Royal Prince Alfred Hospital /ID# 259320
Camperdown, New South Wales, Australia
Liverpool Hospital /ID# 259321
Liverpool, New South Wales, Australia
Peter MacCallum Cancer Center /ID# 260431
Melbourne, New South Wales, Australia
Westmead Hospital /ID# 261465
Westmead, New South Wales, Australia
Townsville University Hospital /ID# 259323
Douglas, Queensland, Australia
Royal Brisbane and Women's Hospital /ID# 259326
Herston, Queensland, Australia
Princess Alexandra Hospital - Woolloongabba /ID# 259329
Woolloongabba, Queensland, Australia
Peninsula Private Hospital /ID# 259325
Frankston, Victoria, Australia
Fiona Stanley Hospital /ID# 259324
Murdoch, Western Australia, Australia
Royal Perth Hospital /ID# 259319
Perth, Western Australia, Australia
Algemeen Ziekenhuis klina /ID# 260324
Brasschaat, Antwerpen, Belgium
Uza /Id# 260319
Edegem, Antwerpen, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 260311
Brussels, Brussels Capital, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 260325
Liège, Liege, Belgium
UZ Gent /ID# 260312
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 260304
Leuven, Vlaams-Brabant, Belgium
AZ-Delta. /ID# 260313
Roeselare, West-Vlaanderen, Belgium
DF Star /ID# 260844
Brasília, Federal District, Brazil
Oncocentro de Minas Gerais /ID# 260973
Belo Horizonte, Minas Gerais, Brazil
Hospital Erasto Gaertner /ID# 260871
Curitiba, Paraná, Brazil
Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 260828
Jaú, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 260843
Ribeirão Preto, São Paulo, Brazil
Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 260827
São Paulo, São Paulo, Brazil
Grupo Oncoclinicas Botafogo /ID# 260870
Rio de Janeiro, Brazil
Real e Benemérita Associação Portuguesa de Beneficência /ID# 260826
São Paulo, Brazil
Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 260829
São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 260822
São Paulo, Brazil
UMHAT Dr Georgi Stranski EAD /ID# 260763
Pleven, Bulgaria
Acibadem City Clinic Tokuda University Hospital EAD /ID# 260685
Sofia, Bulgaria
UMHAT Sveti Ivan Rilski /ID# 259277
Sofia, Bulgaria
SHAT Hematologic Diseases /ID# 260457
Sofia, Bulgaria
Victoria Hospital /ID# 260770
London, Ontario, Canada
The Ottawa Hospital - General Campus /ID# 264470
Ottawa, Ontario, Canada
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 260527
Lévis, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal /ID# 260617
Montreal, Quebec, Canada
Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 261075
Montreal, Quebec, Canada
Peking University First Hospital /ID# 259816
Beijing, Beijing Municipality, China
Peking University Third Hospital /ID# 259806
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University /ID# 260014
Xiamen, Fujian, China
Sun Yat-Sen University Cancer Center /ID# 260478
Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital /ID# 260446
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University /ID# 260558
Guangzhou, Guangdong, China