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A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05283720
Recruitment Status : Recruiting
First Posted : March 17, 2022
Last Update Posted : April 9, 2024
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 cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 394 adult participants with NHL will be enrolled in 100 sites globally.

In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28-day or 21 day cycles dependent on the arm in combination with the anti-neoplastic agents described below:

1: Oral lenalidomide in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in participants with with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in participants with newly diagnosed treatment-naïve DLBCL; 4: Oral CC-99282 in participants with R/R DLBCL; 5: Oral CC-99282 in participants with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in participants with R/R mantle cell lymphoma (MCL); 6B: Oral ibrutinib, and oral venetoclax in participants with R/R MCL; 7: Oral ibrutinib, and oral venetoclax in participants with newly diagnosed treatment-naïve MCL.

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
Non-Hodgkin Lymphoma Drug: Epcoritamab Drug: Lenalidomide Drug: Ibrutinib Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Hydrochloride [HCl] Drug: Prednisone Drug: Polatuzumab Vedotin Drug: Venetoclax Drug: CC-99282 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 394 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma
Actual Study Start Date : June 14, 2022
Estimated Primary Completion Date : November 26, 2032
Estimated Study Completion Date : November 26, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: Dose Escalation
Participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) will receive escalating doses of subcutaneous (SC) epcoritamab in combination with oral lenalidomide in 28 day cycles.
 Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013;

Drug: Lenalidomide
Oral; Capsule
Experimental: Arm 2: Dose Escalation
Participants with R/R DLBCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.
 Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013;

Drug: Lenalidomide
Oral; Capsule

Drug: Ibrutinib
Oral; Capsule
Other Name: Imbruvica
Experimental: Arm 3: Dose Escalation
Participants with newly diagnosed treatment-naïve DLBCL will receive escalating doses of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles.
 Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013;

Drug: Rituximab
Intravenous (IV); Injection

Drug: Cyclophosphamide
IV; Injection

Drug: Doxorubicin Hydrochloride [HCl]
IV; Injection

Drug: Prednisone
Oral; Tablet

Drug: Polatuzumab Vedotin
IV; Injection
Experimental: Arm 4: Dose Escalation
Participants with R/R DLBCL will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
 Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013;

Drug: CC-99282
Oral; Capsule
Experimental: Arm 5: Dose Escalation
Participants with R/R follicular lymphoma (FL) will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
 Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013;

Drug: CC-99282
Oral; Capsule
Experimental: Arm 6A: Dose Escalation
Participants with R/R mantle cell lymphoma (MCL) will receive escalating doses of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.
 Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013;

Drug: Ibrutinib
Oral; Capsule
Other Name: Imbruvica
Experimental: Arm 6B: Dose Escalation
Participants with R/R MCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
 Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013;

Drug: Ibrutinib
Oral; Capsule
Other Name: Imbruvica

Drug: Venetoclax
Oral; Tablet
Other Names:
  • Venclexta;
  • ABT-199
  • GDC-0199
Experimental: Arm 7: Dose Escalation
Participants with newly diagnosed treatment-naïve MCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
 Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013;
Experimental: Arm 1: Dose Expansion
Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral lenalidomide in 28 day cycles.
 Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013;

Drug: Lenalidomide
Oral; Capsule
Experimental: Arm 2: Dose Expansion
Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.
 Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013;

Drug: Lenalidomide
Oral; Capsule

Drug: Ibrutinib
Oral; Capsule
Other Name: Imbruvica
Experimental: Arm 3: Dose Expansion
Participants newly diagnosed treatment-naïve DLBCL will receive the recommended dose of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles.
 Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013;

Drug: Rituximab
Intravenous (IV); Injection

Drug: Cyclophosphamide
IV; Injection

Drug: Doxorubicin Hydrochloride [HCl]
IV; Injection

Drug: Prednisone
Oral; Tablet

Drug: Polatuzumab Vedotin
IV; Injection
Experimental: Arm 4: Dose Expansion
Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
 Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013;
Experimental: Arm 5: Dose Expansion
Participants with R/R FL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
 Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013;
Experimental: Arm 6: Dose Expansion
Participants with R/R MCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.
 Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013;

Drug: Ibrutinib
Oral; Capsule
Other Name: Imbruvica
Experimental: Arm 7: Dose Expansion
Participants with newly diagnosed treatment-naïve MCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
 Drug: Ibrutinib
Oral; Capsule
Other Name: Imbruvica

Drug: Venetoclax
Oral; Tablet
Other Names:
  • Venclexta;
  • ABT-199
  • GDC-0199


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Dose-Limiting Toxicities (DLT) [ Time Frame: Up to Approximately 5 Years ]
    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.


Secondary Outcome Measures :
  1. Best Overall Response (BOR) per Investigator [ Time Frame: Up to Approximately 5 Years ]
    BOR is defined as the percentage of participants who achieved best overall response of CR or PR by Lugano 2014 criteria as assessed by the investigator.

  2. Duration of response (DOR) per Investigator [ Time Frame: Up to Approximately 5 Years ]
    DOR is defined for participants who achieved best overall response of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by the investigator, or death from any cause.

  3. Number of Participants with Progression-free survival (PFS) [ Time Frame: Up to Approximately 5 Years ]
    PFS 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.

  4. Percentage of Participants with Complete Response (CR) [ Time Frame: Up to Approximately 5 Years ]
    CR is defined as the percentage of participantswho achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.

  5. Time-to-response (TTR) [ Time Frame: Up to Approximately 5 Years ]
    TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by investigator.

  6. Time to Next Antilymphoma Therapy (TTNT) [ Time Frame: Up to Approximately 5 Years ]
    Time to next antilymphoma therapy.

  7. Rate of Minimal Residual Disease (MRD) Negativity [ Time Frame: Up to Approximately 5 Years ]
    MRD is defined as the percentage of participants with assessment of the minimal residual disease.

  8. Overall Survival (OS) [ Time Frame: Up to Approximately 5 Years ]
    (OS) is defined as the time in months from first dose of epcoritamab to 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:

    -- Diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma (FL) or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:

    • DLBCL, not otherwise specified (NOS).
    • High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible.
    • Follicular lymphoma (FL) Grade 3B. OR
  • FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR
  • Mantle cell lymphoma (MCL) with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, FISH, or polymerase chain reaction (PCR).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2, except for Arms 6 and 7 where ECOG performance status must be 0-1.

  • Must have 1 or more measurable disease sites:

    • A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND
    • At least 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or magnetic resonance imaging (MRI).

Exclusion Criteria:

  • Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.
  • Toxicities from prior anticancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia. Other eligibility criteria (e.g., laboratory, cardiac criteria) must also be met.
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): NCT05283720


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: NCT05283720    
Other Study ID Numbers: M22-132
2021-005725-24 ( EudraCT Number )
First Posted: March 17, 2022    Key Record Dates
Last Update Posted: April 9, 2024
Last Verified: April 2024
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:
Non-Hodgkin Lymphoma
Epcoritamab
Lenalidomide
Ibrutinib
Polatuzumab Vedotin
Rituximab
Cyclophosphamide
Doxorubicin Hydrochloride (HCl]
Prednisone (pola-R-CHP)
 ABBV-GMAB-3013
Cancer
Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL), Venetoclax,
Venclexta
ABT-199
GDC-0199
CC-99282
EPCORE
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Liposomal doxorubicin
Lenalidomide
Venetoclax
 Ibrutinib
Polatuzumab vedotin
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