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

NCT05451810 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: M23-362
• Study Type: interventional
• Target: 184
• Locations: 2 countries
• Sites: 72

Brief 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.

Conditions

Diffuse Large B-Cell Lymphoma; Classic Follicular Lymphoma

Keywords

Relapsed or Refractory Diffuse Large B-Cell Lymphoma; Relapsed or Refractory Classic Follicular Lymphoma; Non-Hodgkins Lymphoma; Cancer; Epcoritamab; ABBV-GMAB-3013; EPCORE

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Experiencing Grade 3 or Higher Cytokine Release Syndrome (CRS) Events

  Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.

  Up to 3 Months

• Percentage of Participants Experiencing Grade 3 or Higher Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events

  ICANS events will be graded using ASTCT, with a higher grade indicating higher severity.

  Up to 3 Months

• Percentage of Participants Experiencing Grade 3 or Higher Neurotoxicity (Ntox) Events

  Ntox is defined as the percentage of participants who developed at least 1 Grade 3 or higher Ntox since the initiation of epcoritamab treatment.

  Up to 3 Months

Secondary Outcomes (22)

• Best Overall Response (BOR) Determined by Lugano 2014 Criteria Per Investigator Assessment

  Up to 3 Months

• CR Determined by Lugano 2014 Criteria Per Investigator Assessment

  Up to 3 Months

• Diversity Enriched Cohort: Incidence of Treatment-Emergent Adverse Events (TEAEs) by Severity Level

  Up to 3 Months

• Diversity Enriched Cohort: Severity of TEAEs by Severity Level

  Up to 3 Months

• Diversity Enriched Cohort: Incidence of Serious Adverse Events (SAEs) by Severity Level

  Up to 3 Months

Study Arms (4)

Main Cohort: Epcoritamab Diffuse Large B-Cell Lymphoma (DLBCL)

EXPERIMENTAL

Participants with relapsed or refractory (R/R) DLBCL will receive subcutaneous (SC) epcoritamab in 28 day cycles.

Drug: Epcoritamab

Main Cohort: Epcoritamab Classic Follicular Lymphoma (cFL)

EXPERIMENTAL

Participants with R/R cFL will receive SC epcoritamab in 28 day cycles.

Drug: Epcoritamab

Diversity Enriched Cohort: Epcoritamab DLBCL

EXPERIMENTAL

Participants with R/R DLBCL will receive SC epcoritamab in 28 day cycles.

Drug: Epcoritamab

Diversity Enriched Cohort: Epcoritamab cFL

EXPERIMENTAL

Participants with R/R cFL will receive SC epcoritamab in 28 day cycles.

Drug: Epcoritamab

Interventions

Epcoritamab DRUG

Subcutaneous Injection (SC)

Also known as: ABBV-GMAB-3013

Diversity Enriched Cohort: Epcoritamab DLBCL; Diversity Enriched Cohort: Epcoritamab cFL; Main Cohort: Epcoritamab Classic Follicular Lymphoma (cFL); Main Cohort: Epcoritamab Diffuse Large B-Cell Lymphoma (DLBCL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genmab: lead
• AbbVie: collaborator

Study Sites (72)

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

Mobile, Alabama, 36607, United States

Location

University of Arkansas for Medical Sciences /ID# 244562

Little Rock, Arkansas, 72205, United States

Location

Highlands Oncology Group, PA /ID# 245002

Springdale, Arkansas, 72762, United States

Location

Beverly Hills Cancer Center /ID# 255327

Beverly Hills, California, 90211, United States

Location

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

Fountain Valley, California, 92708-7501, United States

Location

UCSF Fresno /ID# 263286

Fresno, California, 93701-2302, United States

Location

University of California, Los Angeles /ID# 244573

Los Angeles, California, 90095, United States

Location

Rocky Mountain Cancer Centers - Boulder /ID# 247653

Boulder, Colorado, 80303, United States

Location

Bennett Cancer Center - Stamford Hospital /ID# 244530

Stamford, Connecticut, 06902-3602, United States

Location

MedStar Washington Hospital Center /ID# 246068

Washington D.C., District of Columbia, 20010, United States

Location

Cancer Specialists of North Florida /ID# 261842

Jacksonville, Florida, 32256, United States

Location

Florida Cancer Specialists /ID# 260854

Lake Mary, Florida, 32746-2115, United States

Location

Mount Sinai Medical Center-Miami Beach /ID# 249045

Miami Beach, Florida, 33140-2948, United States

Location

Memorial Hospital West /ID# 248432

Pembroke Pines, Florida, 33028, United States

Location

BRCR Medical Center Inc /ID# 262527

Tamarac, Florida, 33321-2919, United States

Location

Cleveland Clinic Florida /ID# 244532

Weston, Florida, 33331-3609, United States

Location

Emory University, Winship Cancer Institute /ID# 246056

Atlanta, Georgia, 30322, United States

Location

University of Illinois at Chicago /ID# 245038

Chicago, Illinois, 60607, United States

Location

Illinois Cancer Specialists /ID# 247655

Niles, Illinois, 60714, United States

Location

Parkview Comprehensive Cancer Center /ID# 244545

Fort Wayne, Indiana, 46845, United States

Location

Indiana Blood & Marrow Transpl /ID# 244971

Indianapolis, Indiana, 46237, United States

Location

University of Iowa Health Care /ID# 258227

Des Moines, Iowa, 50314-3017, United States

Location

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

Baton Rouge, Louisiana, 70808, United States

Location

American Oncology Partners of Maryland /ID# 244968

Bethesda, Maryland, 20817, United States

Location

Maryland Oncology Hematology /ID# 254192

Columbia, Maryland, 21044-3128, United States

Location

Tufts Medical Center /ID# 246074

Boston, Massachusetts, 02111-1552, United States

Location

Massachusetts General Hospital /ID# 245239

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center /ID# 248651

Boston, Massachusetts, 02215-5400, United States

Location

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

Grand Rapids, Michigan, 49546-7062, United States

Location

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

Ypsilanti, Michigan, 48197-1051, United States

Location

Hattiesburg Clinic /ID# 244980

Hattiesburg, Mississippi, 39401, United States

Location

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

Chesterfield, Missouri, 63017, United States

Location

NHO - Nebraska Hematology-Oncology /ID# 263164

Lincoln, Nebraska, 68506, United States

Location

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

Lebanon, New Hampshire, 03756, United States

Location

The John Theurer Cancer /ID# 262532

Hackensack, New Jersey, 07601, United States

Location

Morristown Medical Center /ID# 244973

Morristown, New Jersey, 07960-6136, United States

Location

University of New Mexico /ID# 252434

Albuquerque, New Mexico, 87102-4517, United States

Location

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

New Hyde Park, New York, 11042, United States

Location

Stony Brook University Medical Center /ID# 244631

New York, New York, 10021, United States

Location

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

New York, New York, 10028, United States

Location

Icahn School of Medicine at Mount Sinai /ID# 258610

New York, New York, 10029, United States

Location

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

New York, New York, 10065-6007, United States

Location

New York Cancer and Blood Specialists /ID# 259016

Port Jefferson Station, New York, 11776-8060, United States

Location

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

The Bronx, New York, 10469, United States

Location

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

Greenville, North Carolina, 27834, United States

Location

Wake Forest Univ HS /ID# 245005

Winston-Salem, North Carolina, 27157, United States

Location

Oncology Hematology Care, Inc. /ID# 246182

Cincinnati, Ohio, 45236-2725, United States

Location

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

Columbus, Ohio, 43214-3908, United States

Location

Toledo Clinic Cancer Center - Main /ID# 246852

Toledo, Ohio, 43623, United States

Location

University of Oklahoma, Stephenson Cancer Center /ID# 244568

Oklahoma City, Oklahoma, 73104-5418, United States

Location

Willamette Valley Cancer Institute and Research Center /ID# 246410

Eugene, Oregon, 97401-6043, United States

Location

Oregon Oncology Specialists in Salem /ID# 260570

Salem, Oregon, 97301-3975, United States

Location

Lehigh Valley Hospital-Cedar Crest /ID# 244984

Allentown, Pennsylvania, 18103-6202, United States

Location

Spoknwrd Clinical Trials /ID# 265232

Easton, Pennsylvania, 18045, United States

Location

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

Hershey, Pennsylvania, 17033-2360, United States

Location

UPMC Hillman Cancer Ctr /ID# 244571

Pittsburgh, Pennsylvania, 15232, United States

Location

Reading Hospital; McGlinn Cancer Institute /ID# 259181

West Reading, Pennsylvania, 19611-2143, United States

Location

Prisma Health /ID# 247654

Greenville, South Carolina, 29605, United States

Location

The West Clinic /ID# 245004

Memphis, Tennessee, 38120, United States

Location

Vanderbilt University Medical Center /ID# 260953

Nashville, Tennessee, 37232, United States

Location

Texas Oncology - Austin Midtown /ID# 247656

Austin, Texas, 78705, United States

Location

Texas Oncology-Presbyterian Cancer Center Dallas /ID# 262659

Dallas, Texas, 75231, United States

Location

Texas Oncology - Dallas - Worth Street /ID# 262956

Dallas, Texas, 75246, United States

Location

University of Texas Southwestern Medical Center /ID# 244552

Dallas, Texas, 75390-7208, United States

Location

Texas Oncology - San Antonio Medical Center /ID# 247658

San Antonio, Texas, 78240-5251, United States

Location

Texas Oncology - Northeast Texas /ID# 247657

Tyler, Texas, 75702, United States

Location

Virginia Cancer Specialists - Gainesville /ID# 248760

Gainesville, Virginia, 20155-3257, United States

Location

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

Norfolk, Virginia, 23502, United States

Location

Blue Ridge Cancer Center /ID# 260597

Roanoke, Virginia, 24014-2419, United States

Location

Northwest Medical Specialties - Tacoma /ID# 245045

Tacoma, Washington, 98405, United States

Location

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

Rio Piedras, 00935, Puerto Rico

Location

Auxilio Mutuo Cancer Center /ID# 254953

San Juan, 00918, Puerto Rico

Location

Related Links

• Related info

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Recurrence; Lymphoma, Non-Hodgkin; Neoplasms

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: August 17, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (70); PR (2)