A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma

Purpose

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Classic Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) who have received at least 1 prior line of systemic antilymphoma therapy including at least 1 anti-CD20 monoclonal antibody-containing therapy or R/R classic follicular lymphoma (cFL). Adverse events will be assessed. Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R cFL. Study doctors will assess participants in a monotherapy treatment arm of epcoritamab. Participants will receive escalating doses of epcoritamab, until full dose is achieved. Approximately 184 adult participants with R/R DLBCL and R/R cFL will be enrolled in the study in approximately 80 sites in the United States of America. Participants will receive escalating doses of subcutaneous epcoritamab, until full dose is achieved, in 28-day cycles. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Conditions

  • Diffuse Large B-Cell Lymphoma
  • Classic Follicular Lymphoma

Eligibility

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

Inclusion Criteria

  • Life expectancy >3 months on standard of care (SOC) treatment. - Meets the following disease activity criteria: -- Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): - Documented CD20+ mature B-cell neoplasm according to the the 5th edition of World Health Organization (WHO) classification of Haematolymphoid Tumours, based on most recent representative pathology report; - Diffuse large B-cell lymphoma, not otherwise specified (NOS) (de novo or transformed from follicular lymphoma (FL) or Marginal Zone Lymphoma [MZL]); - High-grade B-cell Lymphoma including "double-hit" or "triple-hit" DLBCL (technically classified in WHO 2022 or 2016 as high-grade B-cell lymphoma [HGBCL], with MYC and BCL2 and/or BCL6 translocations). - Follicular large B-cell lymphoma (FLBL, formerly FL grade 3B); - Relapsed or refractory disease and previously treated with at least 1 prior systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody-containing therapy; Note: Relapsed disease is defined as disease that previously responded to therapy but progressed >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response to prior therapy, or progressed within 6 months after completion of therapy (including maintenance therapy). - Either failed prior autologous hematopoietic stem cell transplantation (HSCT), or ineligible for autologous HSCT including but not limited to age, Eastern Cooperative Oncology Group (ECOG) performance status, participant decision, comorbidities and/or insufficient response to prior treatment. - R/R Follicular Lymphoma: - Documented CD20+ mature B-cell neoplasm according to the 5th edition of WHO classification of Haematolymphoid Tumours, based on representative pathology report; --- Classic FL (cFL) (previously FL grade 1, 2, or 3a) without clinical or pathological evidence of transformation; - Relapsed or refractory disease and previously treated with at least 2 prior lines of systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody containing therapy; Note: Relapsed disease is defined as disease that previously responded to therapy but progressed >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response to prior therapy, or progressed within 6 months after completion of therapy (including maintenance therapy). - Previously treated with an alkylating agent or lenalidomide; - Relapsed or refractory to the last prior line therapy. Previous lymphoma therapy is defined as 1 of the following: At least 2 months of single-agent therapy, at least 2 consecutive cycles of combination therapy, autologous HSCT, immunomodulatory therapy, or radioimmunotherapy. - Has at least one target lesion defined as: - >= 1 measurable nodal lesion (long axis > 1.5 cm) and/or >= 1 measurable extranodal lesion (long axis > 1.0 cm) on CT (or MRI) AND - FDG PET scan demonstrating positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites. - Must have ECOG performance status 0 - 2. - Must have acceptable organ (renal, liver, and hematologic) function within the screening period prior to the first dose of study drug: - Absolute neutrophil count (ANC) >= 1.0 × 10^9/L (growth factor support allowed in case of bone marrow involvement, but participant must have not received growth factor within 14 days prior to screening lab collection); - Hemoglobin >= 8.0 g/dL (RBC transfusions permitted, but participants must not have received blood transfusions within 7 days prior to Screening lab collection); - Platelet count >= 75 × 10^9/L, or >= 50 × 10^9/L in the presence of bone marrow involvement or splenomegaly (platelet transfusions are permitted, but participants must not have received blood transfusions within 7 days prior to Screening lab collection); - International normalized ratio (INR) (or Prothrombin Time [PT]) and aPTT <= 1.5 × upper limit of normal (ULN), unless receiving anticoagulation - Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) <= 3.0 × upper limit of normal (ULN); unless due to hepatic involvement of disease or non-hepatic origin. For participants with hepatic involvement of disease, serum AST and serum ALT <= 5.0 × ULN - Direct bilirubin <= 2 × ULN; - Estimated creatine clearance (CrCl) as calculated by Cockcroft-Gault Formula >= 45 mL/min, or estimated glomerular filtration rate (eGFR) as calculated by Modification of Diet in Renal Disease [MDRD] equation >= 45 mL/min; - Lymphocyte count < 5 × 10^9/L.

Exclusion Criteria

  • Have a primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening as confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan (brain) and, if clinically indicated, by lumbar puncture. - Uncontrolled Human Immunodeficiency Virus (HIV) infection. HIV viral load that is undetectable and controlled with medication for at least 1 year prior to enrollment is allowed. Note: If participant has no history of HIV infection, HIV testing does not need to be conducted at screening unless it is required per local guidelines or institutional standards.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Main Cohort: Epcoritamab Diffuse Large B-Cell Lymphoma (DLBCL) 		Participants with relapsed or refractory (R/R) DLBCL will receive subcutaneous (SC) epcoritamab in 28 day cycles.
  • Drug: Epcoritamab
    Subcutaneous Injection (SC)
    Other names:
    • ABBV-GMAB-3013
Experimental
Main Cohort: Epcoritamab Classic Follicular Lymphoma (cFL) 		Participants with R/R cFL will receive SC epcoritamab in 28 day cycles.
  • Drug: Epcoritamab
    Subcutaneous Injection (SC)
    Other names:
    • ABBV-GMAB-3013
Experimental
Diversity Enriched Cohort: Epcoritamab DLBCL 		Participants with R/R DLBCL will receive SC epcoritamab in 28 day cycles.
  • Drug: Epcoritamab
    Subcutaneous Injection (SC)
    Other names:
    • ABBV-GMAB-3013
Experimental
Diversity Enriched Cohort: Epcoritamab cFL 		Participants with R/R cFL will receive SC epcoritamab in 28 day cycles.
  • Drug: Epcoritamab
    Subcutaneous Injection (SC)
    Other names:
    • ABBV-GMAB-3013

Recruiting Locations

Infirmary Health - Infirmary Cancer Care at Mobile Infirmary /ID# 264630
Mobile, Alabama 36607

University of Arkansas for Medical Sciences /ID# 244562
Little Rock, Arkansas 72205

Highlands Oncology Group, PA /ID# 245002
Springdale, Arkansas 72762

Beverly Hills Cancer Center /ID# 255327
Beverly Hills, California 90211

Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133
Fountain Valley, California 92708-7501
Contact:
Site Coordinator
(714) 698-0300

UCSF Fresno /ID# 263286
Fresno, California 93701-2302

University of California, Los Angeles /ID# 244573
Los Angeles, California 90095

Rocky Mountain Cancer Centers - Boulder /ID# 247653
Boulder, Colorado 80303

MedStar Washington Hospital Center /ID# 246068
Washington, District of Columbia 20010

Cancer Specialists of North Florida /ID# 261842
Jacksonville, Florida 32256
Contact:
Site Coordinator
904-538-4488

Florida Cancer Specialists /ID# 260854
Lake Mary, Florida 32746-2115

Mount Sinai Medical Center-Miami Beach /ID# 249045
Miami Beach, Florida 33140-2948

Memorial Hospital West /ID# 248432
Pembroke Pines, Florida 33028

BRCR Medical Center Inc /ID# 262527
Tamarac, Florida 33321-2919

Cleveland Clinic Florida /ID# 244532
Weston, Florida 33331-3609

Emory University, Winship Cancer Institute /ID# 246056
Atlanta, Georgia 30322

University of Illinois at Chicago /ID# 245038
Chicago, Illinois 60607

Illinois Cancer Specialists /ID# 247655
Niles, Illinois 60714

Parkview Comprehensive Cancer Center /ID# 244545
Fort Wayne, Indiana 46845
Contact:
Site Coordinator
1-833-724-8326

Indiana Blood & Marrow Transpl /ID# 244971
Indianapolis, Indiana 46237

Mission Cancer and Blood /ID# 258227
Des Moines, Iowa 50314-3017
Contact:
Site Coordinator
515-282-2921

Our Lady of the Lake Regional Medical Center /ID# 255008
Baton Rouge, Louisiana 70808-4375

American Oncology Partners of Maryland /ID# 244968
Bethesda, Maryland 20817
Contact:
Site Coordinator
301-571-2016

Maryland Oncology Hematology /ID# 254192
Columbia, Maryland 21044-3128

Tufts Medical Center /ID# 246074
Boston, Massachusetts 02111-1552

Massachusetts General Hospital /ID# 245239
Boston, Massachusetts 02114

Beth Israel Deaconess Medical Center /ID# 248651
Boston, Massachusetts 02215-5400

Cancer & Hematology Centers of Western Michigan - East /ID# 244985
Grand Rapids, Michigan 49546-7062
Contact:
Site Coordinator
(616) 954-9800

Trinity Health St. Joseph Mercy Ann Arbor /ID# 244547
Ypsilanti, Michigan 48197-1051

Hattiesburg Clinic /ID# 244980
Hattiesburg, Mississippi 39401
Contact:
Site Coordinator
601-261-1700

St. Luke's Hospital - Chesterfield /ID# 247815
Chesterfield, Missouri 63017

NHO - Nebraska Hematology-Oncology /ID# 263164
Lincoln, Nebraska 68506

Dartmouth-Hitchcock Medical Center /ID# 245003
Lebanon, New Hampshire 03756

The John Theurer Cancer /ID# 262532
Hackensack, New Jersey 07601

University of New Mexico /ID# 252434
Albuquerque, New Mexico 87102-4517

New York Cancer and Blood Specialists - Bronx /ID# 264690
Bronx, New York 10469

New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 264681
New Hyde Park, New York 11042

Stony Brook University Medical Center /ID# 244631
New York, New York 10021

New York Cancer and Blood Specialists - New York /ID# 264676
New York, New York 10028

Icahn School of Medicine at Mount Sinai /ID# 258610
New York, New York 10029

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244628
New York, New York 10065-6007

New York Cancer and Blood Specialists /ID# 259016
Port Jefferson Station, New York 11776-8060

East Carolina University - Brody School of Medicine /ID# 248989
Greenville, North Carolina 27834

Wake Forest Univ HS /ID# 245005
Winston-Salem, North Carolina 27157

Oncology Hematology Care, Inc. /ID# 246182
Cincinnati, Ohio 45236-2725

Ohio Health /ID# 260803
Columbus, Ohio 43214-3908

Toledo Clinic Cancer Center - Main /ID# 246852
Toledo, Ohio 43623

University of Oklahoma, Stephenson Cancer Center /ID# 244568
Oklahoma City, Oklahoma 73104-5418

Willamette Valley Cancer Institute and Research Center /ID# 246410
Eugene, Oregon 97401-6043

Oregon Oncology Specialists in Salem /ID# 260570
Salem, Oregon 97301-3975

Lehigh Valley Hospital-Cedar Crest /ID# 244984
Allentown, Pennsylvania 18103-6202
Contact:
Site Coordinator
610-402-9543

Spoknwrd Clinical Trials /ID# 265232
Easton, Pennsylvania 18045

Penn State Milton S. Hershey Medical Center /ID# 244979
Hershey, Pennsylvania 17033-2360

UPMC Hillman Cancer Ctr /ID# 244571
Pittsburgh, Pennsylvania 15232

Reading Hospital; McGlinn Cancer Institute /ID# 259181
West Reading, Pennsylvania 19611-2143

The West Clinic /ID# 245004
Memphis, Tennessee 38120
Contact:
Site Coordinator
901-683-0055

Texas Oncology - Austin Midtown /ID# 247656
Austin, Texas 78705

Texas Oncology-Presbyterian Cancer Center Dallas /ID# 262659
Dallas, Texas 75231

Texas Oncology - Dallas - Worth Street /ID# 262956
Dallas, Texas 75246

University of Texas Southwestern Medical Center /ID# 244552
Dallas, Texas 75390-7208

Texas Oncology - San Antonio Medical Center /ID# 247658
San Antonio, Texas 78240-5251

Texas Oncology - Northeast Texas /ID# 247657
Tyler, Texas 75702

Virginia Cancer Specialists - Gainesville /ID# 248760
Gainesville, Virginia 20155-3257

Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 265514
Norfolk, Virginia 23502

Blue Ridge Cancer Center /ID# 260597
Roanoke, Virginia 24014-2419

Northwest Medical Specialties - Tacoma /ID# 245045
Tacoma, Washington 98405

Pan American Center for Oncology Trials, LLC /ID# 254952
Rio Piedras, Puerto Rico 00935

Auxilio Mutuo Cancer Center /ID# 254953
San Juan, Puerto Rico 00918

More Details

NCT ID
NCT05451810
Status
Recruiting
Sponsor
Genmab

Study Contact

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