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

Purpose

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.

Condition

  • Follicular Lymphoma (FL)

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy 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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A1: Epcoritamab + Lenalidomide and Rituximab (R2) 		Participants will receive epcoritamab in combination with R2 (ER2), followed by epcoritamab during the 120 week treatment duration.
  • Drug: Epcoritamab
    Subcutaneous (SC) Injection
    Other names:
    • ABBV-GMAB-3013
    • GEN3013
    • Epkinly
  • Drug: Rituximab
    Intravenous (IV) Infusion
  • Drug: Lenalidomide
    Oral Capsule
Experimental
Arm A2: Epcoritamab + Lenalidomide and Rituximab (R2) 		Participants will receive epcoritamab in combination with R2 (ER2), during the 24 week treatment duration.
  • Drug: Epcoritamab
    Subcutaneous (SC) Injection
    Other names:
    • ABBV-GMAB-3013
    • GEN3013
    • Epkinly
  • Drug: Rituximab
    Intravenous (IV) Infusion
  • Drug: Lenalidomide
    Oral Capsule
Experimental
Arm B: Chemoimmunotherapy (CIT) Option A 		Participants will receive CIT Option A (obinutuzumab (G) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) [G-CHOP]/ rituximab (R)-CHOP during the 120 week treatment duration.
  • Drug: Prednisone
    Oral Tablet
  • Drug: Rituximab
    Intravenous (IV) Infusion
  • Drug: Doxorubicin
    IV Injection
  • Drug: Vincristine
    IV Injection
  • Drug: Cyclophosphamide
    IV Injection
  • Drug: Obinutuzumab
    IV Infusion
Experimental
Arm B: Chemoimmunotherapy (CIT) Option B 		Participants will receive CIT Option B (G and bendamustine (Benda) [G-Benda]/R-Benda during the 120 week treatment duration.
  • Drug: Prednisone
    Oral Tablet
  • Drug: Rituximab
    Intravenous (IV) Infusion
  • Drug: Obinutuzumab
    IV Infusion
  • Drug: Bendamustine
    IV Infusion
Experimental
Arm C: Lenalidomide and Rituximab (R2) 		Participants will receive lenalidomide and rituximab (R2) during the 120 week treatment duration.
  • Drug: Rituximab
    Intravenous (IV) Infusion
  • Drug: Lenalidomide
    Oral Capsule

Recruiting Locations

Sansum Clinic Research /ID# 261596
Santa Barbara, California 93105

Rocky Mountain Cancer Centers - Boulder /ID# 261203
Boulder, Colorado 80303

Christiana Care Health Service /ID# 261207
Newark, Delaware 19713

Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445
Jacksonville, Florida 32256
Contact:
Site Coordinator
904-538-4488

Advent Health /ID# 261578
Orlando, Florida 32803

Orlando Health Cancer Institute /ID# 260983
Orlando, Florida 32806

Beacon Cancer Care /ID# 260670
Coeur d'Alene, Idaho 83814

Northwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 259814
Chicago, Illinois 60611-4494

Cancer Care Specialists Of Central Illinois /ID# 272464
Decatur, Illinois 62526

Illinois Cancer Care, PC /ID# 261526
Peoria, Illinois 61615

Fort Wayne Medical Oncology and Hematology- South Office /ID# 259583
Fort Wayne, Indiana 46804

University of Iowa Health Care /ID# 262132
Des Moines, Iowa 50314-3017

University of Louisville Hospital /ID# 260544
Louisville, Kentucky 40202

Norton Cancer Institute - St. Matthews /ID# 261076
Louisville, Kentucky 40207

New England Cancer Specialists - Westbrook /ID# 260672
Westbrook, Maine 04092

University of Maryland, Baltimore /ID# 259538
Baltimore, Maryland 21201

American Oncology Partners of Maryland /ID# 259476
Bethesda, Maryland 20817

St. Luke's Hospital - Chesterfield /ID# 260489
Chesterfield, Missouri 63017

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 260006
Billings, Montana 59102

Nebraska Cancer Specialists (NCS) - Regional Cancer Center - St Francis Location /ID# 262506
Grand Island, Nebraska 68803

Nebraska Cancer Specialists - Omaha - Wright Street /ID# 262505
Omaha, Nebraska 68130

University of Nebraska Medical Center /ID# 261996
Omaha, Nebraska 68198

University of New Mexico /ID# 261083
Albuquerque, New Mexico 87102-4517

Presbyterian Kaseman Hospital /ID# 262451
Albuquerque, New Mexico 87110

Presbyterian Rust Medical Center /ID# 262447
Rio Rancho, New Mexico 87124

New York Oncology Hematology - Albany Cancer Center /ID# 261814
Albany, New York 12206-5013

Icahn School of Medicine at Mount Sinai /ID# 259595
New York, New York 10029

New York Oncology Hematology /ID# 270208
Troy, New York 12180

Clinical Research Alliance, Inc. /ID# 261078
Westbury, New York 11590-5156

Novant Health Presbyterian Medical Center /ID# 259740
Charlotte, North Carolina 28204

Novant Health Forsyth Medical Center /ID# 259741
Winston-Salem, North Carolina 27103

Oncology Hematology Care, Inc - Blue Ash /ID# 261204
Cincinnati, Ohio 45252

Taylor Cancer Research Center /ID# 260488
Maumee, Ohio 43537-1921

Oncology Associates of Oregon, P.C. /ID# 261816
Eugene, Oregon 97401

MUSC Hollings Cancer Center /ID# 259604
Charleston, South Carolina 29425

Prisma Health /ID# 259602
Greenville, South Carolina 29605

Texas Oncology - Austin Midtown /ID# 261208
Austin, Texas 78705

Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 261206
Dallas, Texas 75246-2003

MD Anderson Cancer Center /ID# 260984
Houston, Texas 77030-4000

Oncology Consultants /ID# 268390
Houston, Texas 77030

Joe Arrington Cancer Research /ID# 260382
Lubbock, Texas 79410

Intermountain Healthcare LDS Hospital /ID# 259759
Salt Lake City, Utah 84143

Virginia Cancer Specialists - Fairfax /ID# 261205
Fairfax, Virginia 22031

Oncology and Hematology Associates of Southwest Virginia /ID# 261592
Roanoke, Virginia 98684

Vista Oncology - East Olympia /ID# 261360
Olympia, Washington 98506-5028

Virginia Mason Hospital & Medical Center /ID# 260549
Seattle, Washington 98101

Northwest Medical Specialties - Tacoma /ID# 262133
Tacoma, Washington 98405

Pan American Center for Oncology Trials, LLC /ID# 260265
Rio Piedras, Puerto Rico 00935

Auxilio Mutuo Cancer Center /ID# 260262
San Juan, Puerto Rico 00918
Contact:
Site Coordinator
787-758-2000 x 3569

More Details

NCT ID
NCT06191744
Status
Recruiting
Sponsor
Genmab

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center