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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 Classic Follicular Lymphoma

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ClinicalTrials.gov Identifier: NCT05451810
Recruitment Status : Recruiting
First Posted : July 11, 2022
Last Update Posted : May 7, 2024
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Genmab

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma Classic Follicular Lymphoma Drug: Epcoritamab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Non-Randomized
Intervention Model: Sequential 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 Classic Follicular Lymphoma (Previously Grade 1-3a) When Administered in the Outpatient Setting
Actual Study Start Date : August 17, 2022
Estimated Primary Completion Date : August 29, 2027
Estimated Study Completion Date : May 1, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: ABBV-GMAB-3013


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Experiencing Grade 3 or Higher Cytokine Release Syndrome (CRS) Events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. Best Overall Response (BOR) Determined by Lugano 2014 Criteria Per Investigator Assessment [ Time Frame: Up to 3 Months ]
    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.

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

  3. Diversity Enriched Cohort: Incidence of Treatment-Emergent Adverse Events (TEAEs) by Severity Level [ Time Frame: 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. Diversity Enriched Cohort: Severity of TEAEs by Severity Level [ Time Frame: 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. Diversity Enriched Cohort: Incidence of Serious Adverse Events (SAEs) by Severity Level [ Time Frame: 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. Diversity Enriched Cohort: Severity of SAEs by Severity Level [ Time Frame: 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. Diversity Enriched Cohort: Median Time to Onset of CRS of Grade 3 or Higher [ Time Frame: Up to 3 Months ]
    Median time to onset of CRS of Grade 3 or higher.

  8. Diversity Enriched Cohort: Median Time to Resolution of CRS of Grade 3 or Higher [ Time Frame: Up to 3 Months ]
    Median time to resolution of CRS of Grade 3 or higher.

  9. Diversity Enriched Cohort: Median Time to Onset of ICANS of Grade 3 or Higher [ Time Frame: Up to 3 Months ]
    Median time to onset of ICANS of Grade 3 or higher.

  10. Diversity Enriched Cohort: Median Time to Resolution of ICANS of Grade 3 or Higher [ Time Frame: Up to 3 Months ]
    Median time to resolution of ICANS of Grade 3 or higher.

  11. Diversity Enriched Cohort: Median Time to Onset of Ntox of Grade 3 or Higher [ Time Frame: Up to 3 Months ]
    Median time to onset of Ntox of Grade 3 or higher.

  12. Diversity Enriched Cohort: Median Time to Resolution of Ntox of Grade 3 or Higher [ Time Frame: Up to 3 Months ]
    Median time to resolution of Ntox of Grade 3 or higher.

  13. Diversity Enriched Cohort: Percentage of Participants Experiencing Any Adverse Events (AE)s [ Time Frame: 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. Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of CRS After the First Full Dose of Epcoritamab [ Time Frame: Up to 3 Months ]
    Percentage of participants receiving various interventions for the management of CRS after the first full dose of epcoritamab.

  15. Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of ICANS After the First Full Dose of Epcoritamab [ Time Frame: Up to 3 Months ]
    Percentage of participants receiving various interventions for the management of ICANS after the first full dose of epcoritamab.

  16. Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of Ntox After the First Full Dose of Epcoritamab [ Time Frame: Up to 3 Months ]
    Percentage of participants receiving various interventions for the management of Ntox after the first full dose of epcoritamab.

  17. Diversity Enriched Cohort: Duration of response (DOR) [ Time Frame: Up to 3 Months ]
    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.

  18. Diversity Enriched Cohort: Progression-free survival (PFS) [ Time Frame: Up to 3 Months ]
    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.

  19. Diversity Enriched Cohort: Overall survival (OS) [ Time Frame: Up to 3 Months ]
    Overall survival is defined for as the time in months from first dose of epcoritamab to death from any cause.

  20. Diversity Enriched Cohort: Time-to-response (TTR) [ Time Frame: Up to 3 Months ]
    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.

  21. Diversity Enriched Cohort: Duration of CR (DOCR) [ Time Frame: Up to 3 Months ]
    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.

  22. Diversity Enriched Cohort: Time to Next Treatment [ Time Frame: Up to 3 Months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05451810


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

Locations
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Sponsors and Collaborators
Genmab
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Additional Information:

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Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT05451810    
Other Study ID Numbers: M23-362
First Posted: July 11, 2022    Key Record Dates
Last Update Posted: May 7, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible clinical trial data sharing. 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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/
URL: https://vivli.org/ourmember/abbvie/

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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 Genmab:
Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Relapsed or Refractory Classic Follicular Lymphoma
Non-Hodgkins Lymphoma
Cancer
 Epcoritamab
ABBV-GMAB-3013
EPCORE
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin