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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 Follicular Lymphoma

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05451810
Collaborator
Genmab (Industry)
80
Enrollment
39
Locations
1
Arm
36.8
Anticipated Duration (Months)
2.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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). 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) or R/R follicular lymphoma (FL). Adverse events will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R FL. 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 80 adult participants with R/R DLBCL and R/R FL will be enrolled in the study in approximately 40 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma Grade 1-3a When Administered in the Outpatient Setting
Actual Study Start Date :
Jul 20, 2022
Anticipated Primary Completion Date :
Aug 14, 2025
Anticipated Study Completion Date :
Aug 14, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Epcoritamab

Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.

Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Experiencing Grade 3 or Higher Cytokine Release Syndrome (CRS) Events [Up to 3 Months]

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

    2. Percentage of Participants Experiencing Grade 3 or Higher Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events [Up to 3 Months]

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

    3. Percentage of Participants Experiencing Grade 3 or Higher Neurotoxicity (Ntox) Events [Up to 3 Months]

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

    Secondary Outcome Measures

    1. Overall Response Rate (ORR) Determined by Lugano 2014 Criteria Per Investigator Assessment [Up to 3 Months]

      ORR 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.

    2. CR Rate Determined by Lugano 2014 Criteria Per Investigator Assessment [Up to 3 Months]

      Complete response rate is defined as the percentage of participants who achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.

    3. Incidence of Treatment-Emergent Adverse Events (TEAEs) by Severity Level [Up to 3 Months]

      Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.

    4. Severity of TEAEs by Severity Level [Up to 3 Months]

      Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.

    5. Incidence of Serious Adverse Events (SAEs) by Severity Level [Up to 3 Months]

      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.

    6. Severity of SAEs by Severity Level [Up to 3 Months]

      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.

    7. Median Time to Onset of CRS of Grade 3 or Higher [Up to 3 Months]

      Median time to onset of CRS of Grade 3 or higher.

    8. Median Time to Resolution of CRS of Grade 3 or Higher [Up to 3 Months]

      Median time to resolution of CRS of Grade 3 or higher.

    9. Median Time to Onset of ICANS of Grade 3 or Higher [Up to 3 Months]

      Median time to onset of ICANS of Grade 3 or higher.

    10. Median Time to Resolution of ICANS of Grade 3 or Higher [Up to 3 Months]

      Median time to resolution of ICANS of Grade 3 or higher.

    11. Median Time to Onset of Ntox of Grade 3 or Higher [Up to 3 Months]

      Median time to onset of Ntox of Grade 3 or higher.

    12. Median Time to Resolution of Ntox of Grade 3 or Higher [Up to 3 Months]

      Median time to resolution of Ntox of Grade 3 or higher.

    13. Percentage of Participants Experiencing Any Adverse Events (AE)s [Up to 3 Months]

      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.

    14. Percentage of Participants Receiving Various Interventions for the Management of CRS After the First Full Dose of Epcoritamab [Up to 3 Months]

      Percentage of participants receiving various interventions for the management of CRS after the first full dose of epcoritamab.

    15. Percentage of Participants Receiving Various Interventions for the Management of ICANS After the First Full Dose of Epcoritamab [Up to 3 Months]

      Percentage of participants receiving various interventions for the management of ICANS after the first full dose of epcoritamab.

    16. Percentage of Participants Receiving Various Interventions for the Management of Ntox After the First Full Dose of Epcoritamab [Up to 3 Months]

      Percentage of participants receiving various interventions for the management of Ntox after the first full dose of epcoritamab.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) or R/R Follicular Lymphoma (FL) grade 1, 2, or 3a, with documented CD20+ mature B-cell neoplasm according to World Health Organization (WHO) classification 2016 or WHO classification 2008 based on representative pathology report:

    • 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 2 prior systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody-containing therapy.

    • Must have 1 or more measurable disease sites:

    • Fluorodeoxyglucose (FDG)-avid lymphomas: Measurable disease with computerized tomography (CT) (or magnetic resonance imaging [MRI]) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis

    1.0 cm (or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis >= 1.0 cm) AND FDG positron emission tomography (PET) scan demonstrating positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites.

    • FDG-nonavid lymphomas: Measurable disease with CT (or MRI) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis >= 1.0 cm.

    • Must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

    • Adequate organ function.

    Exclusion Criteria:
    • Central nervous system (CNS) involvement.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133 Fountain Valley California United States 92708-7501
    2 Kaiser Permanente Medical Ctr-Vallejo /ID# 244989 Vallejo California United States 94589-2441
    3 Rocky Mountain Cancer Centers /ID# 247653 Boulder Colorado United States 80303
    4 Bennett Cancer Center - Stamford Hospital /ID# 244530 Stamford Connecticut United States 06902-3602
    5 Memorial Cancer Institute (MCI) - Memorial Hospital West /ID# 248432 Pembroke Pines Florida United States 33028-1023
    6 NW Georgia Oncology Centers /ID# 247756 Marietta Georgia United States 30060
    7 Beacon Cancer Care /ID# 245018 Coeur d'Alene Idaho United States 83814-2668
    8 University of Illinois - Chicago /ID# 245038 Chicago Illinois United States 60607
    9 Illinois Cancer Specialists /ID# 247655 Niles Illinois United States 60714
    10 Parkview Cancer Institute /ID# 244545 Fort Wayne Indiana United States 46845-1739
    11 Indiana Blood & Marrow Transpl /ID# 244971 Indianapolis Indiana United States 46237
    12 American Oncology Partners of Maryland, PA /ID# 244968 Bethesda Maryland United States 20817
    13 Tufts Medical Center /ID# 246074 Boston Massachusetts United States 02111-1552
    14 Massachusetts General Hospital /ID# 245239 Boston Massachusetts United States 02114
    15 Beth Israel Deaconess Medical Center /ID# 248651 Boston Massachusetts United States 02215-5400
    16 St. Joseph Mercy Hospital /ID# 244547 Ypsilanti Michigan United States 48197-1051
    17 Hattiesburg Clinic /ID# 244980 Hattiesburg Mississippi United States 39401
    18 St. Luke's Hospitals /ID# 247815 Chesterfield Missouri United States 63017-3406
    19 David C. Pratt Cancer Center /ID# 244986 Saint Louis Missouri United States 63141
    20 Dartmouth-Hitchcock Medical Center /ID# 245003 Lebanon New Hampshire United States 03756
    21 Morristown Medical Center /ID# 244973 Morristown New Jersey United States 07960-6136
    22 Rutgers Cancer Institute of New Jersey /ID# 248235 New Brunswick New Jersey United States 08901
    23 Stony Brook University Medical Center /ID# 244631 New York New York United States 10021
    24 University of Rochester Cancer Center /ID# 245033 Rochester New York United States 14642-0001
    25 East Carolina University Brody School of Medicine /ID# 248989 Greenville North Carolina United States 27834
    26 Wake Forest Univ HS /ID# 245005 Winston-Salem North Carolina United States 27157
    27 Oncology Hematology Care, Inc. /ID# 246182 Cincinnati Ohio United States 45236-2725
    28 Toledo Clinic Cancer Center /ID# 246852 Toledo Ohio United States 43623
    29 University of Oklahoma, Stephenson Cancer Center /ID# 244568 Oklahoma City Oklahoma United States 73104-5418
    30 Willamette Valley Cancer Institute and Research Center /ID# 246410 Eugene Oregon United States 97401-6043
    31 Lehigh Valley Hospital-Cedar Crest /ID# 244984 Allentown Pennsylvania United States 18103-6202
    32 Penn State Milton S. Hershey Medical Center /ID# 244979 Hershey Pennsylvania United States 17033-2360
    33 UPMC Hillman Cancer Ctr /ID# 244571 Pittsburgh Pennsylvania United States 15232
    34 Prisma Health Cancer Institute-Faris Road /ID# 247654 Greenville South Carolina United States 29605-4255
    35 Texas Oncology - Austin Midtown /ID# 247656 Austin Texas United States 78705
    36 Texas Oncology - San Antonio Medical Center /ID# 247658 San Antonio Texas United States 78240-5251
    37 Texas Oncology - Northeast Texas /ID# 247657 Tyler Texas United States 75702
    38 Virginia Cancer Specialists - Gainesville /ID# 248760 Gainesville Virginia United States 20155-3257
    39 Northwest Medical Specialties - Tacoma /ID# 245045 Tacoma Washington United States 98405

    Sponsors and Collaborators

    • AbbVie
    • Genmab

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05451810
    Other Study ID Numbers:
    • M23-362
    First Posted:
    Jul 11, 2022
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by AbbVie
    Relapsed or Refractory Diffuse Large B-Cell Lymphoma
    Relapsed or Refractory Follicular Lymphoma
    Non-Hodgkins Lymphoma
    Cancer
    Epcoritamab
    ABBV-GMAB-3013
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Follicular
    Lymphoma, B-Cell
    Lymphoma, Large B-Cell, Diffuse

    Study Results

    No Results Posted as of Jul 29, 2022