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

Last updated: January 22, 2025
Sponsor: Genmab
Overall Status: Active - Not Recruiting

Phase

2

Condition

Follicular Lymphoma

Lymphoma, B-cell

Lymphoproliferative Disorders

Treatment

Epcoritamab

Clinical Study ID

NCT05451810
M23-362
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 ofWorld 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 ortransformed 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 priorsystemic antineoplastic therapies including at least 1 anti-CD20 monoclonalantibody-containing therapy; Note: Relapsed disease is defined as disease thatpreviously responded to therapy but progressed >= 6 months after completion oftherapy. Refractory disease is defined as disease that either progressed duringtherapy, failed to achieve an objective response to prior therapy, orprogressed within 6 months after completion of therapy (including maintenancetherapy).

  • Either failed prior autologous hematopoietic stem cell transplantation (HSCT),or ineligible for autologous HSCT including but not limited to age, EasternCooperative 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 WHOclassification of Haematolymphoid Tumours, based on representative pathologyreport; --- Classic FL (cFL) (previously FL grade 1, 2, or 3a) without clinical orpathological evidence of transformation;

  • Relapsed or refractory disease and previously treated with at least 2 priorlines of systemic antineoplastic therapies including at least 1 anti-CD20monoclonal antibody containing therapy; Note: Relapsed disease is defined asdisease that previously responded to therapy but progressed >= 6 months aftercompletion of therapy. Refractory disease is defined as disease that eitherprogressed during therapy, failed to achieve an objective response to priortherapy, or progressed within 6 months after completion of therapy (includingmaintenance therapy).

  • Previously treated with an alkylating agent or lenalidomide;

  • Relapsed or refractory to the last prior line therapy. Previous lymphomatherapy is defined as 1 of the following: At least 2 months of single-agenttherapy, 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 measurableextranodal 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 thescreening period prior to the first dose of study drug:

  • Absolute neutrophil count (ANC) >= 1.0 × 10^9/L (growth factor support allowedin case of bone marrow involvement, but participant must have not receivedgrowth factor within 14 days prior to screening lab collection);

  • Hemoglobin >= 8.0 g/dL (RBC transfusions permitted, but participants must nothave received blood transfusions within 7 days prior to Screening labcollection);

  • Platelet count >= 75 × 10^9/L, or >= 50 × 10^9/L in the presence of bone marrowinvolvement or splenomegaly (platelet transfusions are permitted, butparticipants must not have received blood transfusions within 7 days prior toScreening 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 ofdisease or non-hepatic origin. For participants with hepatic involvement ofdisease, 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 byModification of Diet in Renal Disease [MDRD] equation >= 45 mL/min;

  • Lymphocyte count < 5 × 10^9/L.

Exclusion

Exclusion Criteria:

  • Have a primary central nervous system (CNS) lymphoma or known CNS involvement bylymphoma including leptomeningeal disease, at screening as confirmed by magneticresonance imaging (MRI)/computed tomography (CT) scan (brain) and, if clinicallyindicated, by lumbar puncture.

  • Uncontrolled Human Immunodeficiency Virus (HIV) infection. HIV viral load that isundetectable and controlled with medication for at least 1 year prior to enrollmentis allowed. Note: If participant has no history of HIV infection, HIV testing doesnot need to be conducted at screening unless it is required per local guidelines orinstitutional standards.

Study Design

Total Participants: 184
Treatment Group(s): 1
Primary Treatment: Epcoritamab
Phase: 2
Study Start date:
August 17, 2022
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Pan American Center for Oncology Trials, LLC /ID# 254952

    Rio Piedras, 00935
    Puerto Rico

    Site Not Available

  • Auxilio Mutuo Cancer Center /ID# 254953

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • Infirmary Health - Infirmary Cancer Care at Mobile Infirmary /ID# 264630

    Mobile, Alabama 36607
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences /ID# 244562

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Highlands Oncology Group, PA /ID# 245002

    Springdale, Arkansas 72762
    United States

    Site Not Available

  • Beverly Hills Cancer Center /ID# 255327

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133

    Fountain Valley, California 92708-7501
    United States

    Site Not Available

  • UCSF Fresno /ID# 263286

    Fresno, California 93701-2302
    United States

    Site Not Available

  • University of California, Los Angeles /ID# 244573

    Los Angeles, California 90095
    United States

    Site Not Available

  • Kaiser Permanente Medical Ctr-Vallejo /ID# 244989

    Vallejo, California 94589-2441
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers - Boulder /ID# 247653

    Boulder, Colorado 80303
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers /ID# 247653

    Boulder, Colorado 80303
    United States

    Active - Recruiting

  • Bennett Cancer Center - Stamford Hospital /ID# 244530

    Stamford, Connecticut 06902-3602
    United States

    Site Not Available

  • MedStar Washington Hospital Center /ID# 246068

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Cancer Specialists of North Florida /ID# 261842

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Florida Cancer Specialists /ID# 260854

    Lake Mary, Florida 32746-2115
    United States

    Site Not Available

  • Miami Cancer Institute Baptist Health South Florida /ID# 244972

    Miami, Florida 33176
    United States

    Site Not Available

  • Mount Sinai Medical Center-Miami Beach /ID# 249045

    Miami Beach, Florida 33140-2948
    United States

    Site Not Available

  • Memorial Cancer Institute (MCI) - Memorial Hospital West /ID# 248432

    Pembroke Pines, Florida 33028-1023
    United States

    Active - Recruiting

  • Memorial Hospital West /ID# 248432

    Pembroke Pines, Florida 33028
    United States

    Site Not Available

  • BRCR Medical Center Inc /ID# 262527

    Tamarac, Florida 33321-2919
    United States

    Site Not Available

  • Cleveland Clinic Florida /ID# 244532

    Weston, Florida 33331-3609
    United States

    Site Not Available

  • Emory University, Winship Cancer Institute /ID# 246056

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • NW Georgia Oncology Centers /ID# 247756

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Beacon Cancer Care /ID# 245018

    Coeur d'Alene, Idaho 83814-2668
    United States

    Site Not Available

  • University of Illinois - Chicago /ID# 245038

    Chicago, Illinois 60607
    United States

    Active - Recruiting

  • University of Illinois at Chicago /ID# 245038

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Illinois Cancer Specialists /ID# 247655

    Niles, Illinois 60714
    United States

    Site Not Available

  • Parkview Cancer Institute /ID# 244545

    Fort Wayne, Indiana 46845-1739
    United States

    Active - Recruiting

  • Parkview Comprehensive Cancer Center /ID# 244545

    Fort Wayne, Indiana 46845
    United States

    Site Not Available

  • Indiana Blood & Marrow Transpl /ID# 244971

    Indianapolis, Indiana 46237
    United States

    Site Not Available

  • Mission Cancer and Blood /ID# 258227

    Des Moines, Iowa 50314-3017
    United States

    Active - Recruiting

  • University of Iowa Health Care /ID# 258227

    Des Moines, Iowa 50314-3017
    United States

    Site Not Available

  • Our Lady Of The Lake Regional Medical Center /ID# 255008

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Our Lady of the Lake Regional Medical Center /ID# 255008

    Baton Rouge, Louisiana 70808-4375
    United States

    Active - Recruiting

  • American Oncology Partners of Maryland /ID# 244968

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • American Oncology Partners of Maryland, PA /ID# 244968

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Maryland Oncology Hematology /ID# 254192

    Columbia, Maryland 21044-3128
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center /ID# 248651

    Boston, Massachusetts 02215-5400
    United States

    Site Not Available

  • Massachusetts General Hospital /ID# 245239

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Tufts Medical Center /ID# 246074

    Boston, Massachusetts 02111-1552
    United States

    Site Not Available

  • Cancer & Hematology Centers of Western Michigan - East /ID# 244985

    Grand Rapids, Michigan 49546-7062
    United States

    Site Not Available

  • St. Joseph Mercy Hospital /ID# 244547

    Ypsilanti, Michigan 48197-1051
    United States

    Active - Recruiting

  • Trinity Health St. Joseph Mercy Ann Arbor /ID# 244547

    Ypsilanti, Michigan 48197-1051
    United States

    Site Not Available

  • Hattiesburg Clinic /ID# 244980

    Hattiesburg, Mississippi 39401
    United States

    Site Not Available

  • St. Luke's Hospital - Chesterfield /ID# 247815

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • St. Luke's Hospitals /ID# 247815

    Chesterfield, Missouri 63017-3406
    United States

    Active - Recruiting

  • David C. Pratt Cancer Center /ID# 244986

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • NHO - Nebraska Hematology-Oncology /ID# 263164

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 245003

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center /ID# 245003

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • The John Theurer Cancer /ID# 262532

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Morristown Medical Center /ID# 244973

    Morristown, New Jersey 07960-6136
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey /ID# 248235

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • University of New Mexico /ID# 252434

    Albuquerque, New Mexico 87102-4517
    United States

    Site Not Available

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

    Bronx, New York 10469
    United States

    Site Not Available

  • New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 264681

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai /ID# 258610

    New York, New York 10029
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244628

    New York, New York 10065-6007
    United States

    Site Not Available

  • New York Cancer and Blood Specialists - New York /ID# 264676

    New York, New York 10028
    United States

    Site Not Available

  • Stony Brook University Medical Center /ID# 244631

    New York, New York 10021
    United States

    Site Not Available

  • New York Cancer and Blood Specialists /ID# 259016

    Port Jefferson Station, New York 11776-8060
    United States

    Site Not Available

  • University of Rochester Cancer Center /ID# 245033

    Rochester, New York 14642-0001
    United States

    Site Not Available

  • East Carolina University - Brody School of Medicine /ID# 248989

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • East Carolina University Brody School of Medicine /ID# 248989

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Wake Forest Univ HS /ID# 245005

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Oncology Hematology Care, Inc. /ID# 246182

    Cincinnati, Ohio 45236-2725
    United States

    Site Not Available

  • Ohio Health /ID# 260803

    Columbus, Ohio 43214-3908
    United States

    Active - Recruiting

  • OhioHealth Arthur G.H. Bing, MD Cancer Center /ID# 260803

    Columbus, Ohio 43214-3908
    United States

    Site Not Available

  • Dayton VA Medical Center /ID# 249114

    Dayton, Ohio 45428
    United States

    Site Not Available

  • Toledo Clinic Cancer Center - Main /ID# 246852

    Toledo, Ohio 43623
    United States

    Site Not Available

  • Toledo Clinic Cancer Center /ID# 246852

    Toledo, Ohio 43623
    United States

    Active - Recruiting

  • University of Oklahoma, Stephenson Cancer Center /ID# 244568

    Oklahoma City, Oklahoma 73104-5418
    United States

    Site Not Available

  • Willamette Valley Cancer Institute and Research Center /ID# 246410

    Eugene, Oregon 97401-6043
    United States

    Site Not Available

  • Oregon Oncology Specialists in Salem /ID# 260570

    Salem, Oregon 97301-3975
    United States

    Site Not Available

  • Lehigh Valley Hospital-Cedar Crest /ID# 244984

    Allentown, Pennsylvania 18103-6202
    United States

    Site Not Available

  • Spoknwrd Clinical Trials /ID# 265232

    Easton, Pennsylvania 18045
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center /ID# 244979

    Hershey, Pennsylvania 17033-2360
    United States

    Site Not Available

  • UPMC Hillman Cancer Ctr /ID# 244571

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Reading Hospital; McGlinn Cancer Institute /ID# 259181

    West Reading, Pennsylvania 19611-2143
    United States

    Site Not Available

  • Cancer Care Associates of York /ID# 254159

    York, Pennsylvania 17403
    United States

    Site Not Available

  • Medical University of South Carolina /ID# 249968

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Prisma Health /ID# 247654

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Prisma Health Cancer Institute-Faris Road /ID# 247654

    Greenville, South Carolina 29605-4255
    United States

    Active - Recruiting

  • The West Clinic /ID# 245004

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Vanderbilt University Medical Center /ID# 260953

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Texas Oncology - Austin Midtown /ID# 247656

    Austin, Texas 78705
    United States

    Site Not Available

  • Texas Oncology - Dallas - Worth Street /ID# 262956

    Dallas, Texas 75246
    United States

    Site Not Available

  • Texas Oncology-Presbyterian Cancer Center Dallas /ID# 262659

    Dallas, Texas 75231
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center /ID# 244552

    Dallas, Texas 75390-7208
    United States

    Site Not Available

  • Texas Oncology - San Antonio Medical Center /ID# 247658

    San Antonio, Texas 78240-5251
    United States

    Site Not Available

  • Texas Oncology - Northeast Texas /ID# 247657

    Tyler, Texas 75702
    United States

    Site Not Available

  • Huntsman Cancer Institute /ID# 251446

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Virginia Cancer Specialists - Gainesville /ID# 248760

    Gainesville, Virginia 20155-3257
    United States

    Site Not Available

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

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Blue Ridge Cancer Center /ID# 260597

    Roanoke, Virginia 24014-2419
    United States

    Site Not Available

  • Northwest Medical Specialties - Tacoma /ID# 245045

    Tacoma, Washington 98405
    United States

    Site Not Available

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