Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05409066
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Epcoritamab

Subcutaneous Injection

DRUG

Rituximab

Intravenous Infusion

DRUG

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

And 173 more locations on ClinicalTrials.gov