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Trial record 1 of 1 for:    2021-000169-34
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Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma (EPCORE FL-1)

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: NCT05409066
Recruitment Status : Recruiting
First Posted : June 8, 2022
Last Update Posted : November 25, 2022
Sponsor:
Collaborator:
Genmab
Information provided by (Responsible Party):
AbbVie

Brief Summary:

Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 642 adult participants with R/R FL will be enrolled in approximately 300 sites across the world.

Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days).

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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Condition or disease Intervention/treatment Phase
Follicular Lymphoma (FL) Drug: Epcoritamab Drug: Rituximab Drug: Lenalidomide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 642 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)
Actual Study Start Date : September 20, 2022
Estimated Primary Completion Date : December 27, 2029
Estimated Study Completion Date : February 11, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Epcoritamab Dose A in Combination With R2
Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
Drug: Epcoritamab
Subcutaneous Injection
Other Name: GEN3013

Drug: Rituximab
Intravenous Infusion

Drug: Lenalidomide
Oral Capsules

Experimental: Epcoritamab Dose B in Combination With R2
Participants will receive epcoritamab Dose B in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
Drug: Epcoritamab
Subcutaneous Injection
Other Name: GEN3013

Drug: Rituximab
Intravenous Infusion

Drug: Lenalidomide
Oral Capsules

Active Comparator: Lenalidomide and Rituximab (R2)
Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
Drug: Rituximab
Intravenous Infusion

Drug: Lenalidomide
Oral Capsules




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 5 years ]
    PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by independent review committee (IRC) or death (whichever occurs first).


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Complete Response (CR) [ Time Frame: Up to approximately 5 years ]
    Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy.

  2. Percentage of Participants Achieving Best Overall Response (BOR) [ Time Frame: Up to approximately 5 years ]
    Percentage of participants who achieve the BOR of complete response (CR) or partial response (PR) determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy.

  3. Overall Survival (OS) [ Time Frame: Up to approximately 8 years from randomization ]
    Overall survival is defined as the duration from the date of randomization to the date of the participant's death.

  4. Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity [ Time Frame: Up to approximately 5 years ]
    MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of subsequent anti-lymphoma therapy.



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:

  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
  • Participant has:

    • Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
    • >= 1 measurable nodal lesion (long axis >= 1.5 cm and short axis > 1.0 cm) or >= 1 measurable extra-nodal lesion (long axis >= 1.0 cm) on CT scan or MRI.
  • Histologically confirmed Grade 1 to 3a follicular lymphoma (FL) according to the World Health Organization (WHO) 2016 classification with no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy and CD20+ on a representative tumor biopsy based on the pathology report.
  • Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with (an)other anti-lymphoma agent(s).
  • Eligible to receive R2 per investigator determination.

Exclusion Criteria:

  • Documented refractoriness to lenalidomide.
  • Have lenalidomide exposure within 12 months prior to randomization.

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): NCT05409066


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

Locations
Show Show 277 study locations
Sponsors and Collaborators
AbbVie
Genmab
Investigators
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Study Director: ABBVIE INC. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT05409066    
Other Study ID Numbers: M20-638
2021-000169-34 ( EudraCT Number )
First Posted: June 8, 2022    Key Record Dates
Last Update Posted: November 25, 2022
Last Verified: November 2022
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:
Follicular Lymphoma (FL)
Non-Hodgkin's lymphoma (NHL)
Lymphoma
Cancer
Epcoritamab
Rituximab
Lenalidomide
EPCORE FL-1
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Lenalidomide
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors