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A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) (EPCORE DLBCL-2)

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ClinicalTrials.gov Identifier: NCT05578976
Recruitment Status : Recruiting
First Posted : October 13, 2022
Last Update Posted : March 21, 2023
Sponsor:
Collaborator:
Genmab
Information provided by (Responsible Party):
AbbVie

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). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally.

In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-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 Drug: Epcoritamab Drug: Cyclophosphamide Drug: Rituximab Drug: Vincristine Drug: Doxorubicin Drug: Prednisone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Actual Study Start Date : February 8, 2023
Estimated Primary Completion Date : January 31, 2027
Estimated Study Completion Date : June 11, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Steroids
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Epcoritamab and R-CHOP
Participants will receive subcutaneous epcoritamab combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.
 Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013

Drug: Cyclophosphamide
Intravenous (IV) Injection

Drug: Rituximab
IV Infusion

Drug: Vincristine
IV Infusion

Drug: Doxorubicin
IV Infusion

Drug: Prednisone
Oral; Tablet
Experimental: R-CHOP and Rituximab
Participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.
 Drug: Cyclophosphamide
Intravenous (IV) Injection

Drug: Rituximab
IV Infusion

Drug: Vincristine
IV Infusion

Drug: Doxorubicin
IV Infusion

Drug: Prednisone
Oral; Tablet


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5 [ Time Frame: Up to Approximately 46 Months ]
    PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC), or death due to any cause whichever comes first.


Secondary Outcome Measures :
  1. Number of Participants with PFS [ Time Frame: Up to Approximately 46 Months ]
    PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by IRC, or death due to any cause, whichever occurs first.

  2. Number of Participants with Event-free survival (EFS) [ Time Frame: Up to Approximately 46 Months ]
    EFS is defined as the duration from randomization to the date of disease progression determined by Lugano criteria as assessed by IRC, IRC-assessed PR or SD followed by non protocol-specified NALT, a positive biopsy on or after end-of-treatment (EOT), regardless of whether NAL initiated, or death from any cause.

  3. Percentage of Participants with Complete Remission (CR) [ Time Frame: On or After to Approximately 28 Weeks ]
    CR is defined as the absence of lymphoma determined by fluorodeoxyglucose positron emission tomography (FDG-PET),determined by Lugano 2014 criteria as assessed by IRC.

  4. Overall survival (OS) [ Time Frame: Up to Approximately 76 Months ]
    OS is defined as time from randomization until death due to any causes.

  5. Percentage of Participants with Minimal Residual Disease (MRD) Negativity [ Time Frame: Up to Approximately 46 Months ]
    The MRD negativity rate is defined as the percentage of participants who achieve MRD negativity prior to the initiation of any non-protocol-specified new anti-lymphoma therapy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.

  • Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:

    • DLBCL, Not Otherwise Specified (NOS).
    • High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
    • T-cell/histiocyte-rich large B-cell lymphoma.
    • Epstein Barr virus-positive DLBCL, NOS.
    • Follicular lymphoma Grade 3b.

Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.

Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.

  • Availability of archival or freshly collected tumor tissue at Screening. Archival paraffin-embedded tissue must be obtained within 8 weeks prior to Cycle 1 Day 1.
  • Must have an IPI score of 2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.

  • Has at least one target lesion defined as:

    • >= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). AND
    • Positron emission tomography (PET)-positive on PET-CT scan.
  • Laboratory values meeting the criteria laid out in the protocol.
  • Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.

Exclusion Criteria:

  • History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
  • Clinically significant cardiovascular disease as per the protocol.
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): NCT05578976


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

Locations
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Sponsors and Collaborators
AbbVie
Genmab
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT05578976    
Other Study ID Numbers: M20-621
2021-000168-31 ( EudraCT Number )
First Posted: October 13, 2022    Key Record Dates
Last Update Posted: March 21, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.: Yes
Keywords provided by AbbVie:
Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Non-Hodgkins Lymphoma
Cancer
Epcoritamab
 ABBV-GMAB-3013
R-CHOP
Rituximab
Additional relevant MeSH terms:
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Lymphoma
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
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Vincristine
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents