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 Sex
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

Scripps Mercy Hospital /ID# 265393
San Diego 5391811, California 5332921 92103

Sansum Clinic Research /ID# 261596
Santa Barbara 5392952, California 5332921 93105

Rocky Mountain Cancer Centers - Boulder /ID# 261203
Boulder 5574991, Colorado 5417618 80303

Christiana Care Health Service /ID# 261207
Newark 4143861, Delaware 4142224 19713

Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445
Jacksonville 4160021, Florida 4155751 32256
Contact:
Site Coordinator
904-538-4488

Advent Health /ID# 261578
Orlando 4167147, Florida 4155751 32803

Orlando Health Cancer Institute /ID# 260983
Orlando 4167147, Florida 4155751 32806

Moffitt Cancer Center /ID# 259487
Tampa 4174757, Florida 4155751 33612-9416

Beacon Cancer Care /ID# 260670
Coeur d'Alene 5589173, Idaho 5596512 83814

Northwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 259814
Chicago 4887398, Illinois 4896861 60610

Cancer Care Specialists Of Central Illinois /ID# 272464
Decatur 4236895, Illinois 4896861 62526

Loyola University /ID# 259462
Maywood 4901514, Illinois 4896861 60153

Illinois Cancer Care, PC /ID# 261526
Peoria 4905687, Illinois 4896861 61615

Fort Wayne Medical Oncology and Hematology- South Office /ID# 259583
Fort Wayne 4920423, Indiana 4921868 46804

University of Iowa Health Care /ID# 262132
Des Moines 4853828, Iowa 4862182 50314-3017

University of Louisville Hospital /ID# 260544
Louisville 4299276, Kentucky 6254925 40202

Norton Cancer Institute - St. Matthews /ID# 261076
Louisville 4299276, Kentucky 6254925 40207

New England Cancer Specialists - Westbrook /ID# 260672
Westbrook 4982753, Maine 4971068 04092

University of Maryland, Baltimore /ID# 259538
Baltimore 4347778, Maryland 4361885 21201

Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 259476
Bethesda 4348599, Maryland 4361885 20817

St. Luke's Hospital - Chesterfield /ID# 260489
Chesterfield 4381072, Missouri 4398678 63017

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 260006
Billings 5640350, Montana 5667009 59102

Nebraska Cancer Specialists (NCS) - Regional Cancer Center - St Francis Location /ID# 262506
Grand Island 5069297, Nebraska 5073708 68803

NHO - Nebraska Hematology-Oncology /ID# 269692
Lincoln 5072006, Nebraska 5073708 68506

Nebraska Cancer Specialists - Omaha - Wright Street /ID# 262505
Omaha 5074472, Nebraska 5073708 68130

University of Nebraska Medical Center /ID# 261996
Omaha 5074472, Nebraska 5073708 68198

University of New Mexico /ID# 261083
Albuquerque 5454711, New Mexico 5481136 87102-4517

Presbyterian Kaseman Hospital /ID# 262451
Albuquerque 5454711, New Mexico 5481136 87110

Presbyterian Rust Medical Center /ID# 262447
Rio Rancho 5487811, New Mexico 5481136 87124

New York Oncology Hematology - Albany Cancer Center /ID# 261814
Albany 5106834, New York 5128638 12206-5013

NYU Langone Hospital - Long Island /ID# 265531
Mineola 5127134, New York 5128638 11501

NYU Langone Medical Center /ID# 264518
New York 5128581, New York 5128638 10016-6402

Icahn School of Medicine at Mount Sinai /ID# 259595
New York 5128581, New York 5128638 10029

New York Oncology Hematology /ID# 270208
Troy 5141502, New York 5128638 12180

Clinical Research Alliance, Inc. /ID# 261078
Westbury 5144040, New York 5128638 11590-5156

Novant Health Presbyterian Medical Center /ID# 259740
Charlotte 4460243, North Carolina 4482348 28204

Novant Health Forsyth Medical Center /ID# 259741
Winston-Salem 4499612, North Carolina 4482348 27103

Oncology Hematology Care, Inc - Blue Ash /ID# 261204
Cincinnati 4508722, Ohio 5165418 45252

Oncology Associates of Oregon, P.C. /ID# 261816
Eugene 5725846, Oregon 5744337 97401

MUSC Hollings Cancer Center /ID# 259604
Charleston 4574324, South Carolina 4597040 29425

Prisma Health /ID# 259602
Greenville 4580543, South Carolina 4597040 29605

Texas Oncology - Austin Midtown /ID# 261208
Austin 4671654, Texas 4736286 78705

Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 261206
Dallas 4684888, Texas 4736286 75246-2003

MD Anderson Cancer Center /ID# 260984
Houston 4699066, Texas 4736286 77030-4000

Oncology Consultants /ID# 268390
Houston 4699066, Texas 4736286 77030

Joe Arrington Cancer Research /ID# 260382
Lubbock 5525577, Texas 4736286 79410

Intermountain Healthcare LDS Hospital /ID# 259759
Salt Lake City 5780993, Utah 5549030 84143

Virginia Cancer Specialists - Fairfax /ID# 261205
Fairfax 4758023, Virginia 6254928 22031

Oncology and Hematology Associates of Southwest Virginia /ID# 261592
Roanoke 4782167, Virginia 6254928 98684

Swedish Cancer Institute - Edmonds /ID# 266356
Edmonds 5793427, Washington 5815135 98026

Swedish Cancer Institute - Issaquah /ID# 266358
Issaquah 5798487, Washington 5815135 98029

Vista Oncology - East Olympia /ID# 261360
Olympia 5805687, Washington 5815135 98506-5028

Virginia Mason Hospital & Medical Center /ID# 260549
Seattle 5809844, Washington 5815135 98101

Swedish Cancer Institute /ID# 260370
Seattle 5809844, Washington 5815135 98104-3588

Northwest Medical Specialties - Tacoma /ID# 262133
Tacoma 5812944, Washington 5815135 98405

Pan American Center for Oncology Trials, LLC /ID# 260265
Rio Piedras 4829037, Puerto Rico 00935

Auxilio Mutuo Cancer Center /ID# 260262
San Juan 4568127, Puerto Rico 00918
Contact:
Site Coordinator
787-758-2000 x 3569

More Details

Status
Recruiting
Sponsor
Genmab

Study Contact

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