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

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 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.

Condition

  • Follicular Lymphoma (FL)

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2. - Participant has: - Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND - >= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI. - Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report. - Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.) - Eligible to receive R2 per investigator determination. - Estimated Creatinine Clearance (CrCl) >= 50 mL/min.

Exclusion Criteria

  • Documented refractoriness to lenalidomide. - Have lenalidomide exposure within 12 months prior to randomization.

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
Epcoritamab Dose A in Combination With R2 		Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
  • Drug: Epcoritamab
    Subcutaneous Injection
    Other names:
    • GEN3013
  • Drug: Rituximab
    Intravenous Infusion
  • Drug: Lenalidomide
    Oral Capsules
Experimental
Epcoritamab Dose B in Combination With R2 		Participants will receive epcoritamab Dose B in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days). Enrollment is closed for this arm.
  • Drug: Epcoritamab
    Subcutaneous Injection
    Other names:
    • GEN3013
  • Drug: Rituximab
    Intravenous Infusion
  • Drug: Lenalidomide
    Oral Capsules
Active Comparator
Lenalidomide and Rituximab (R2) 		Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
  • Drug: Rituximab
    Intravenous Infusion
  • Drug: Lenalidomide
    Oral Capsules

Recruiting Locations

University of Arizona Cancer Center - North Campus /ID# 228862
Tucson, Arizona 85719-1478

Alta Bates Summit Medical Center for Research /ID# 229428
Berkeley, California 94705

Long Beach Memorial Medical Ct /ID# 228997
Long Beach, California 90806-1701

University of Southern California /ID# 227195
Los Angeles, California 90033

Emory University /ID# 227299
Atlanta, Georgia 30322-1013

Northwestern University Feinberg School of Medicine /ID# 227248
Chicago, Illinois 60611-2927

Community Health Network, Inc. /ID# 259756
Indianapolis, Indiana 46250-2042

Our Lady of the Lake Regional Medical Center /ID# 251393
Baton Rouge, Louisiana 70808-4375

University of Maryland Medical Center /ID# 227191
Baltimore, Maryland 21201

Massachusetts General Hospital /ID# 245233
Boston, Massachusetts 02114

UMass Memorial Medical Center /ID# 227323
Worcester, Massachusetts 01605

Henry Ford Hospital /ID# 227250
Detroit, Michigan 48202

St. Luke's Hospital - Chesterfield /ID# 247817
Chesterfield, Missouri 63017

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 251220
Billings, Montana 59102

Morristown Medical Center /ID# 231427
Morristown, New Jersey 07960-6136

Roswell Park Cancer Institute /ID# 239128
Buffalo, New York 14263

NYU Langone Hospital - Long Island /ID# 253343
Mineola, New York 11501

NYU Laura and Isaac Perlmutter Cancer Center /ID# 227322
New York, New York 10016

Icahn School of Medicine at Mount Sinai /ID# 227181
New York, New York 10029

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193
New York, New York 10065-6007

Baylor Sammons Cancer Center /ID# 261584
Dallas, Texas 75246

Texas Oncology - Northeast Texas /ID# 265890
Tyler, Texas 75702

Intermountain Healthcare LDS Hospital /ID# 259948
Salt Lake City, Utah 84143

Virginia Commonwealth University Medical Center Main Hospital /ID# 227211
Richmond, Virginia 23219

Pan American Center for Oncology Trials, LLC /ID# 230055
Rio Piedras, Puerto Rico 00935

Auxilio Mutuo Cancer Center /ID# 248721
San Juan, Puerto Rico 00918

More Details

NCT ID
NCT05409066
Status
Recruiting
Sponsor
Genmab

Study Contact

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