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

A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) When Administered in the Outpatient Setting

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.

Study Overview

• Status: Recruiting
• Conditions: Diffuse Large B-Cell Lymphoma; Classic Follicular Lymphoma
• Intervention / Treatment: Drug: Epcoritamab

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Recruiting
    • Pan American Center for Oncology Trials, LLC /ID# 254952
  • San Juan, Puerto Rico, 00918
    • Recruiting
    • Auxilio Mutuo Cancer Center /ID# 254953
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • University of Arkansas for Medical Sciences /ID# 244562
  • California
    • Fountain Valley, California, United States, 92708-7501
      • Recruiting
      • Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133
      • Contact: Site Coordinator; Phone Number: (714) 698-0300
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California, Los Angeles /ID# 244573
  • Colorado
    • Boulder, Colorado, United States, 80303
      • Recruiting
      • Rocky Mountain Cancer Centers /ID# 247653
  • Connecticut
    • Stamford, Connecticut, United States, 06902-3602
      • Recruiting
      • Bennett Cancer Center - Stamford Hospital /ID# 244530
  • Florida
    • Miami Beach, Florida, United States, 33140-2948
      • Recruiting
      • Mount Sinai Medical Center-Miami Beach /ID# 249045
    • Pembroke Pines, Florida, United States, 33028-1023
      • Recruiting
      • Memorial Cancer Institute (MCI) - Memorial Hospital West /ID# 248432
    • Weston, Florida, United States, 33331-3609
      • Recruiting
      • Cleveland Clinic Florida /ID# 244532
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Recruiting
      • University of Illinois at Chicago /ID# 245038
    • Niles, Illinois, United States, 60714
      • Recruiting
      • Illinois Cancer Specialists /ID# 247655
  • Indiana
    • Fort Wayne, Indiana, United States, 46845-1739
      • Recruiting
      • Parkview Cancer Institute /ID# 244545
      • Contact: Site Coordinator; Phone Number: 1-833-724-8326
    • Indianapolis, Indiana, United States, 46237
      • Recruiting
      • Indiana Blood & Marrow Transpl /ID# 244971
  • Iowa
    • Des Moines, Iowa, United States, 50314-3017
      • Recruiting
      • Mission Cancer and Blood /ID# 258227
      • Contact: Site Coordinator; Phone Number: 515-282-2921
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808-4375
      • Recruiting
      • Our Lady of the Lake Regional Medical Center /ID# 255008
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Recruiting
      • American Oncology Partners of Maryland, PA /ID# 244968
      • Contact: Site Coordinator; Phone Number: 301-571-2016
    • Columbia, Maryland, United States, 21044-3128
      • Recruiting
      • Maryland Oncology Hematology /ID# 254192
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital /ID# 245239
    • Boston, Massachusetts, United States, 02215-5400
      • Recruiting
      • Beth Israel Deaconess Medical Center /ID# 248651
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts Medical Center /ID# 246074
  • Michigan
    • Grand Rapids, Michigan, United States, 49546-7062
      • Recruiting
      • Cancer & Hematology Centers of Western Michigan - East /ID# 244985
      • Contact: Site Coordinator; Phone Number: (616) 954-9800
    • Ypsilanti, Michigan, United States, 48197-1051
      • Recruiting
      • Trinity Health St. Joseph Mercy Ann Arbor /ID# 244547
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Recruiting
      • Hattiesburg Clinic /ID# 244980
      • Contact: Site Coordinator; Phone Number: 601-261-1700
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Recruiting
      • St. Luke's Hospital - Chesterfield /ID# 247815
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Medical Center /ID# 245003
  • New Jersey
    • Morristown, New Jersey, United States, 07960-6136
      • Recruiting
      • Morristown Medical Center /ID# 244973
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102-4517
      • Recruiting
      • University of New Mexico /ID# 252434
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Stony Brook University Medical Center /ID# 244631
    • Port Jefferson Station, New York, United States, 11776-8060
      • Recruiting
      • New York Cancer and Blood Specialists /ID# 259016
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Recruiting
      • East Carolina University Brody School of Medicine /ID# 248989
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Univ HS /ID# 245005
  • Ohio
    • Cincinnati, Ohio, United States, 45236-2725
      • Recruiting
      • Oncology Hematology Care, Inc. /ID# 246182
    • Toledo, Ohio, United States, 43623
      • Recruiting
      • Toledo Clinic Cancer Center /ID# 246852
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104-5418
      • Recruiting
      • University of Oklahoma, Stephenson Cancer Center /ID# 244568
  • Oregon
    • Eugene, Oregon, United States, 97401-6043
      • Recruiting
      • Willamette Valley Cancer Institute and Research Center /ID# 246410
    • Salem, Oregon, United States, 97301-3975
      • Recruiting
      • Oregon Oncology Specialists in Salem /ID# 260570
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103-6202
      • Recruiting
      • Lehigh Valley Hospital-Cedar Crest /ID# 244984
      • Contact: Site Coordinator; Phone Number: 610-402-9543
    • Hershey, Pennsylvania, United States, 17033-2360
      • Recruiting
      • Penn State Milton S. Hershey Medical Center /ID# 244979
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • UPMC Hillman Cancer Ctr /ID# 244571
    • West Reading, Pennsylvania, United States, 19611-2143
      • Recruiting
      • Reading Hospital; McGlinn Cancer Institute /ID# 259181
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health /ID# 247654
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Recruiting
      • The West Clinic /ID# 245004
      • Contact: Site Coordinator; Phone Number: 901-683-0055
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Texas Oncology - Austin Midtown /ID# 247656
    • Dallas, Texas, United States, 75390-7208
      • Recruiting
      • University of Texas Southwestern Medical Center /ID# 244552
    • San Antonio, Texas, United States, 78240-5251
      • Recruiting
      • Texas Oncology - San Antonio Medical Center /ID# 247658
    • Tyler, Texas, United States, 75702
      • Recruiting
      • Texas Oncology - Northeast Texas /ID# 247657
  • Virginia
    • Gainesville, Virginia, United States, 20155-3257
      • Recruiting
      • Virginia Cancer Specialists - Gainesville /ID# 248760
    • Roanoke, Virginia, United States, 24014-2419
      • Recruiting
      • Blue Ridge Cancer Center /ID# 260597
  • Washington
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • Northwest Medical Specialties - Tacoma /ID# 245045

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) or R/R Classic Follicular Lymphoma (cFL), with documented CD20+ mature B-cell neoplasm according to World Health Organization (WHO) classification 2016 or WHO classification 2008 based on representative and most recent pathology report:

  • Can include participants with "double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Other double-/triple-hit lymphomas are not eligible.
  • Relapsed or refractory disease and previously treated with at least 1 prior systemic anti-lymphoma therapy for DLBCL and 2 prior systemic antineoplastic therapies for cFL including at least 1 anti-CD20 monoclonal antibody-containing therapy

• Has at least one target lesion defined as:

  • ≥ 1 measurable nodal lesion (long axis > 1.5 cm and short axis > 1.0 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 Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
• Adequate organ function.

Exclusion Criteria:

• Central nervous system (CNS) involvement by lymphoma.
• 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 subject 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: 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: 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 cFL; Participants with R/R cFL will receive SC epcoritamab in 28 day cycles.	Drug: Epcoritamab; Subcutaneous Injection (SC); Other Names: ABBV-GMAB-3013

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Overall Response (BOR) Determined by Lugano 2014 Criteria Per Investigator Assessment	BOR is defined as the percentage of participants who achieved best overall response of complete response (CR) or partial response (PR) determined by Lugano 2014 criteria as assessed by investigators.	Up to 3 Months
CR Determined by Lugano 2014 Criteria Per Investigator Assessment	Complete response is defined as the percentage of participants who achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.	Up to 3 Months
Diversity Enriched Cohort: Incidence of Treatment-Emergent Adverse Events (TEAEs) by Severity Level	Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.	Up to 3 Months
Diversity Enriched Cohort: Severity of TEAEs by Severity Level	Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.	Up to 3 Months
Diversity Enriched Cohort: Incidence of Serious Adverse Events (SAEs) by Severity Level	A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.	Up to 3 Months
Diversity Enriched Cohort: Severity of SAEs by Severity Level	A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.	Up to 3 Months
Diversity Enriched Cohort: Median Time to Onset of CRS of Grade 3 or Higher	Median time to onset of CRS of Grade 3 or higher.	Up to 3 Months
Diversity Enriched Cohort: Median Time to Resolution of CRS of Grade 3 or Higher	Median time to resolution of CRS of Grade 3 or higher.	Up to 3 Months
Diversity Enriched Cohort: Median Time to Onset of ICANS of Grade 3 or Higher	Median time to onset of ICANS of Grade 3 or higher.	Up to 3 Months
Diversity Enriched Cohort: Median Time to Resolution of ICANS of Grade 3 or Higher	Median time to resolution of ICANS of Grade 3 or higher.	Up to 3 Months
Diversity Enriched Cohort: Median Time to Onset of Ntox of Grade 3 or Higher	Median time to onset of Ntox of Grade 3 or higher.	Up to 3 Months
Diversity Enriched Cohort: Median Time to Resolution of Ntox of Grade 3 or Higher	Median time to resolution of Ntox of Grade 3 or higher.	Up to 3 Months
Diversity Enriched Cohort: Percentage of Participants Experiencing Any Adverse Events (AE)s	An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to 3 Months
Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of CRS After the First Full Dose of Epcoritamab	Percentage of participants receiving various interventions for the management of CRS after the first full dose of epcoritamab.	Up to 3 Months
Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of ICANS After the First Full Dose of Epcoritamab	Percentage of participants receiving various interventions for the management of ICANS after the first full dose of epcoritamab.	Up to 3 Months
Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of Ntox After the First Full Dose of Epcoritamab	Percentage of participants receiving various interventions for the management of Ntox after the first full dose of epcoritamab.	Up to 3 Months
Diversity Enriched Cohort: Duration of response (DOR)	Duration of response is defined for participants who achieved BOR of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.	Up to 3 Months
Diversity Enriched Cohort: Progression-free survival (PFS)	Progression-free survival is defined as the time in months from the first dose of study drug to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.	Up to 3 Months
Diversity Enriched Cohort: Overall survival (OS)	Overall survival is defined for as the time in months from first dose of epcoritamab to death from any cause.	Up to 3 Months
Diversity Enriched Cohort: Time-to-response (TTR)	Time to response is defined for participants who achieved BOR of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by investigator, as the time in months from first dose of study drug to initial CR/PR.	Up to 3 Months
Diversity Enriched Cohort: Duration of CR (DOCR)	The duration of complete response is defined for participants who achieved BOR of CR (Complete Responders), as the duration from the first CR response to the earliest date of disease progression determined per Lugano 2014 criteria, as assessed by the investigator, or death, whichever occurs first.	Up to 3 Months
Diversity Enriched Cohort: Time to Next Treatment	Time to next treatment is defined as the time from the date of the first dose of study drug to the start of new non-protocol-specified treatment or death from any cause.	Up to 3 Months

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: Genmab
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Estimated): August 29, 2027
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Relapsed or Refractory Diffuse Large B-Cell Lymphoma; Non-Hodgkins Lymphoma; Epcoritamab; ABBV-GMAB-3013; EPCORE; Relapsed or Refractory Classic Follicular Lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Follicular; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: M23-362

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No