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RecruitingInterventionalPhase 3

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)

NCT ID: NCT06191744Sponsor: GenmabLast updated: 2026-06-02

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.

Arms & interventions

  • DrugEpcoritamab

    Subcutaneous (SC) Injection

  • DrugPrednisone

    Oral Tablet

  • DrugRituximab

    Intravenous (IV) Infusion

  • DrugLenalidomide

    Oral Capsule

  • DrugDoxorubicin

    IV Injection

  • DrugVincristine

    IV Injection

  • DrugCyclophosphamide

    IV Injection

  • DrugObinutuzumab

    IV Infusion

  • DrugBendamustine

    IV Infusion

Outcome measures

Primary

  • Arm A1 vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)

    CR30 will be determined by positron emission tomography-computerized tomography (cat scan) \[PET-CT\] per Lugano 2014 criteria, as assessed by independent review committee (IRC).

    Time frame: Up to 30 Months

  • Arm A1 vs Arm B: Number of Participants with Progression-free survival (PFS)

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

    Time frame: Up to 10 Years

Secondary

  • Arm A1 vs Arm B: Overall Survival (OS)

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Rate of Minimal Residual Disease (MRD) Negativity Rate

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Change from Baseline in Physical Functioning (PF) According to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30)

    Time frame: 21 Weeks

  • Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30

    Time frame: Up to 30 Months

  • Arm A1 vs Arm C: Percentage of Participants who Achieve CR30

    Time frame: Up to 30 Months

  • Arm A1 vs Arm A2: Number of Participants with PFS

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Number of Participants with PFS

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Rate of MRD Negativity

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Rate of MRD Negativity

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Change from Baseline in PF According to EORTC QLQ-C30

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Change from Baseline in PF According to EORTC QLQ-C30

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: OS

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: OS

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30

    Time frame: Up to 30 Months

  • Arm A1 vs Arm B: Percentage of Participants who Achieve CR30

    Time frame: Up to 30 Months

  • Arm A1 vs Arm C: Percentage of Participants who Achieve CR30

    Time frame: Up to 30 Months

  • Arm A1 vs Arm A2: Number of Participants with PFS

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Number of Participants with PFS

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Number of Participants with PFS

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Number of Participants with Best Overall Response (BOR) per per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Number of Participants with BOR per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Number of Participants with BOR per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Number of Participants with BOR per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Number of Participants with BOR per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Number of Participants with BOR per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Number of Participants with Event-free Survival (EFS) per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Number of Participants with EFS per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Number of Participants with EFS per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Number of Participants with EFS per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Number of Participants with EFS per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Number of Participants with EFS per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Duration of Response (DOR) per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: DOR per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: DOR per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: DOR per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: DOR per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: DOR per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Duration of Complete Response (DOCR) per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: DOCR per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: DOCR per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: DOCR per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: DOCR per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: DOCR per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Time to Next Anti-lymphoma Therapy (TTNT) per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: TTNT per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: TTNT per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: TTNT per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: TTNT per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: TTNT per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: TTNT per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Time to Progression per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Time to Progression per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Time to Progression per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Time to Progression per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Time to Progression per IRC

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Time to Progression per Investigator

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Number of Participants with Progression-free Survival After Subsequent Anti-Lymphoma Therapy (PFS2)

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Number of Participants with PFS2

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Number of Participants with PFS2

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Change in Tolerability as Measured by Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Change in Tolerability as Measured by PRO-CTCAE

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Change in Tolerability as Measured by PRO-CTCAE

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Change in Tolerability as Measured by The Functional Assessment of Cancer Therapy - General (FACT-G) Item GP5

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Change in Tolerability as Measured by FACT-G Item GP5

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Change in Tolerability as Measured by FACT-GG Item GP5

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Change in Symptoms as Measured by The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Change in Symptoms as Measured by FACT-Lym

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Change in Symptoms as Measured by FACT-Lym

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Change in Quality of Life (QoL) as Measured by FACT-Lym

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Change in QoL as Measured by FACT-Lym

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Change in QoL as Measured by FACT-Lym

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Time-to-first PRO deterioration (TTD) in well-being using the lymphoma subscale (LymS) of FACT-Lym

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: TTD in well-being using LymS of FACT-Lym

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: TTD in well-being using LymS of FACT-Lym

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Change in QoL as Measured by 5-Level European Quality of Life (EuroQol)-5-dimension [EQ-5D-5L]

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Change in QoL as Measured by EQ-5D-5L

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Change in QoL as Measured by EQ-5D-5L

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: TTD in PF using the QLQ-C30 Physical Functioning Scale

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: TTD in PF using the QLQ-C30 Physical Functioning Scale

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: TTD in PF using the QLQ-C30 Physical Functioning Scale

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Change from baseline in the remaining items and domains of the EORTC QLQ-C30

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Change from baseline in the remaining items and domains of the EORTC QLQ-C30

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Change from baseline in the remaining items and domains of the EORTC QLQ-C30

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Change in Patient Global Impression of Change (PGIC) for General Lymphoma Symptoms

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Change in PGIC for General Lymphoma Symptoms

    Time frame: Up to 10 Years

  • Arm A1 vs Arm A2: Change in Patient Global Impression of Severity (PGIS) for General Lymphoma Symptoms

    Time frame: Up to 10 Years

  • Arm A1 vs Arm B: Change in PGIS for General Lymphoma Symptoms

    Time frame: Up to 10 Years

  • Arm A1 vs Arm C: Change in PGIS for General Lymphoma Symptoms

    Time frame: Up to 10 Years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Diagnosis of follicular lymphoma (FL). * Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours. * Are willing and able to comply with procedures required in the protocol. * Must have stage, III, IV or II with bulky disease \>= 7cm). * Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria. * Has one or more target lesions: * A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and * \>=1 measurable nodal lesion (long axis \>1.5cm) or \>=1 measurable extra-nodal lesion (long axis \>1.0 cm) on CT scan or MRI * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: \[Arm B\] at the discretion of the Investigator, and rituximab and lenalidomide (R2) \[Arm C\]. * Have laboratory values meeting the criteria in the protocol. Exclusion Criteria: * Had major surgery within 4 weeks prior to randomization. * Have active cytomegalovirus (CMV) disease.

Study locations (58)

UCSF Fresno /ID# 264712

Fresno, California, 93701-2302

Recruiting

Scripps Mercy Hospital /ID# 265393

San Diego, California, 92103

Recruiting

Sansum Clinic Research /ID# 261596

Santa Barbara, California, 93105

Recruiting

Rocky Mountain Cancer Centers - Boulder /ID# 261203

Boulder, Colorado, 80303

Recruiting

Christiana Care Health Service /ID# 261207

Newark, Delaware, 19713

Recruiting

Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445

Jacksonville, Florida, 32256

Recruiting
Site Coordinator · Contact
904-538-4488

Advent Health /ID# 261578

Orlando, Florida, 32803

Recruiting

Orlando Health Cancer Institute /ID# 260983

Orlando, Florida, 32806

Recruiting

Moffitt Cancer Center /ID# 259487

Tampa, Florida, 33612-9416

Recruiting

Beacon Cancer Care - Coeur d'Alene /ID# 260670

Coeur d'Alene, Idaho, 83814

Recruiting

Northwestern Medicine - Northwestern Memorial Hospital /ID# 259814

Chicago, Illinois, 60611

Recruiting

Cancer Care Specialists Of Central Illinois /ID# 272464

Decatur, Illinois, 62526

Recruiting

Loyola University /ID# 259462

Maywood, Illinois, 60153

Completed

Illinois Cancer Care, PC /ID# 261526

Peoria, Illinois, 61615

Recruiting

Fort Wayne Medical Oncology and Hematology- South Office /ID# 259583

Fort Wayne, Indiana, 46804

Recruiting

University of Iowa Health Care /ID# 262132

Des Moines, Iowa, 50314-3017

Recruiting

University of Louisville Hospital /ID# 260544

Louisville, Kentucky, 40202

Recruiting

Norton Cancer Institute - St. Matthews /ID# 261076

Louisville, Kentucky, 40207

Recruiting

New England Cancer Specialists - Westbrook /ID# 260672

Westbrook, Maine, 04092

Recruiting

University of Maryland, Baltimore /ID# 259538

Baltimore, Maryland, 21201

Recruiting

Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 259476

Bethesda, Maryland, 20817

Recruiting

St. Luke's Hospital - Chesterfield /ID# 260489

Chesterfield, Missouri, 63017

Recruiting

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 260006

Billings, Montana, 59102

Recruiting

Nebraska Cancer Specialists (NCS) - Regional Cancer Center - St Francis Location /ID# 262506

Grand Island, Nebraska, 68803

Recruiting

NHO - Nebraska Hematology-Oncology /ID# 269692

Lincoln, Nebraska, 68506

Recruiting

Nebraska Cancer Specialists - Omaha - Wright Street /ID# 262505

Omaha, Nebraska, 68130

Recruiting

University of Nebraska Medical Center /ID# 261996

Omaha, Nebraska, 68198

Recruiting

University of New Mexico /ID# 261083

Albuquerque, New Mexico, 87102-4517

Recruiting

Presbyterian Kaseman Hospital /ID# 262451

Albuquerque, New Mexico, 87110

Recruiting

Presbyterian Rust Medical Center /ID# 262447

Rio Rancho, New Mexico, 87124

Recruiting

New York Oncology Hematology - Albany Cancer Center /ID# 261814

Albany, New York, 12206-5013

Completed

NYU Langone Hospital - Long Island /ID# 265531

Mineola, New York, 11501

Recruiting

NYU Langone Medical Center /ID# 264518

New York, New York, 10016-6402

Recruiting

Icahn School of Medicine at Mount Sinai /ID# 259595

New York, New York, 10029

Recruiting

New York Oncology Hematology /ID# 270208

Troy, New York, 12180

Recruiting

Clinical Research Alliance - Westbury /ID# 261078

Westbury, New York, 11590

Recruiting

Novant Health Presbyterian Medical Center /ID# 259740

Charlotte, North Carolina, 28204

Recruiting

Novant Health Forsyth Medical Center /ID# 259741

Winston-Salem, North Carolina, 27103

Recruiting

Oncology Hematology Care, Inc - Blue Ash /ID# 261204

Cincinnati, Ohio, 45252

Recruiting

Taylor Cancer Research Center /ID# 260488

Maumee, Ohio, 43537-1921

Completed

Oncology Associates of Oregon, P.C. /ID# 261816

Eugene, Oregon, 97401

Recruiting

MUSC Hollings Cancer Center /ID# 259604

Charleston, South Carolina, 29425

Recruiting

Prisma Health /ID# 259602

Greenville, South Carolina, 29605

Recruiting

Sarah Cannon Research Institute - Tristar Centennial Medical Center /ID# 274985

Nashville, Tennessee, 37203

Recruiting

Texas Oncology - Austin Midtown /ID# 261208

Austin, Texas, 78705

Recruiting

Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 261206

Dallas, Texas, 75246-2003

Recruiting

MD Anderson Cancer Center /ID# 260984

Houston, Texas, 77030-4000

Recruiting

Oncology Consultants /ID# 268390

Houston, Texas, 77030

Recruiting

Joe Arrington Cancer Research /ID# 260382

Lubbock, Texas, 79410

Recruiting

Intermountain Healthcare LDS Hospital /ID# 259759

Salt Lake City, Utah, 84143

Recruiting

Virginia Cancer Specialists - Fairfax /ID# 261205

Fairfax, Virginia, 22031

Recruiting

Oncology and Hematology Associates of Southwest Virginia /ID# 261592

Roanoke, Virginia, 98684

Recruiting

Swedish Cancer Institute - Edmonds /ID# 266356

Edmonds, Washington, 98026

Recruiting

Swedish Cancer Institute - Issaquah /ID# 266358

Issaquah, Washington, 98029

Recruiting

Vista Oncology - East Olympia /ID# 261360

Olympia, Washington, 98506-5028

Recruiting

Virginia Mason Hospital & Medical Center /ID# 260549

Seattle, Washington, 98101

Recruiting

Swedish Medical Center - Seattle /ID# 260370

Seattle, Washington, 98104

Recruiting

Northwest Medical Specialties - Tacoma /ID# 262133

Tacoma, Washington, 98405

Recruiting