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Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma (EPCORE DLBCL-3)

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: NCT05660967
Recruitment Status : Recruiting
First Posted : December 21, 2022
Last Update Posted : June 4, 2024
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Genmab

Brief Summary:
The purpose of the study is to examine efficacy and safety of epcoritamab with and without lenalidomide in newly diagnosed elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) who cannot tolerate anthracycline therapy. Epcoritamab (also known as EPKINLY™, GEN3013 and DuoBody®-CD3xCD20) is an antibody that has already been tested in several clinical studies. All patients will receive active treatment. There is an equal chance of receiving epcoritamab or epcoritamab plus lenalidomide.

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

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Detailed Description:

This is an open-label, multicenter, global phase-2 trial evaluating the efficacy and safety of epcoritamab monotherapy and epcoritamab plus lenalidomide in elderly patients who are deemed anthracycline ineligible.

The trial is designed in two stages:

  • Stage 1 which includes a safety run-in phase in each arm
  • Stage 2, an expansion of the selected treatment from Stage 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Epcoritamab Monotherapy and in Combination With Lenalidomide as First-line Therapy for Anthracycline-ineligible Diffuse Large B-Cell Lymphoma Patients, an Open-label, Randomized, Multicenter, Global Phase 2 Trial
Actual Study Start Date : March 6, 2023
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : March 2027


Arm Intervention/treatment
Experimental: Epcoritamab monotherapy Biological: Epcoritamab
Epcoritamab will be administered by subcutaneous (SC) injections in 28-day cycles for up to 12 cycles.
Other Names:
  • GEN3013
  • DuoBody®-CD3×CD20
  • EPKINLY™

Experimental: Epcoritamab in combination with lenalidomide Biological: Epcoritamab
Epcoritamab will be administered by subcutaneous (SC) injections in 28-day cycles for up to 12 cycles.
Other Names:
  • GEN3013
  • DuoBody®-CD3×CD20
  • EPKINLY™

Drug: Lenalidomide
Lenalidomide will be administered orally (capsules; starting dose of 10 or 20 mg) once daily on Day 1 to Day 21 of each 28-day cycle for up to 12 cycles.
Other Name: Revlimid®




Primary Outcome Measures :
  1. Complete Response (CR) rate [ Time Frame: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years ]
    Percentage of participants achieving CR. Assessed by the Investigator per Lugano criteria


Secondary Outcome Measures :
  1. Duration of response (DOR) [ Time Frame: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years ]
    Defined as the time between date of first response to the date of first documented tumor progression or death (due to any cause) whichever occurs first

  2. Duration of complete response (DOCR) [ Time Frame: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years ]
    Defined as the time between the date of first CR to the date of the first documented tumor progression or death due to any cause, whichever comes first

  3. Time to response (TTR) [ Time Frame: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 1 year ]
    Defined as the time from first dose to first documentation of objective tumor response (CR or PR)

  4. Overall Response Rate (ORR) [ Time Frame: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years ]
    Defined as the percentage of patients who achieve best overall response of complete response (CR) or partial response (PR) determined by Lugano criteria

  5. Progression-free survival (PFS) [ Time Frame: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years ]
    Defined as the time from first dose to date of PD or death (due to any cause) whichever occurs first

  6. Time to next anti-lymphoma therapy (TTNT) [ Time Frame: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years ]
    Defined as the time from first dose to administration of subsequent anti-lymphoma therapy

  7. Rate of minimal residual disease (MRD) negativity [ Time Frame: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years ]
    Percentage of participants with at least 1 post-screening MRD negative result

  8. Overall survival (OS) [ Time Frame: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 3 years ]
    Defined at the timeframe from first dose to death

  9. Incidence and severity of adverse events (AEs) [ Time Frame: From screening until end of the safety follow-up period (60 days after last dose) ]
    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

  10. Incidence of clinically significant shifts in laboratory parameters [ Time Frame: From screening until end of the safety follow-up period (60 days after last dose) ]
    Clinical laboratory parameters assessed: hematology, chemistry, coagulation, tumor lysis, cardiac enzymes, immunoglobulins, and urinalyses

  11. Incidence of anti-drug antibodies (ADAs) to epcoritamab in plasma [ Time Frame: From first dose until treatment discontinuation (assessed up to 12 months) ]
    To evaluate immunogenicity

  12. Evaluate patient-reported outcomes (PROs) related to lymphoma symptoms [ Time Frame: From cycle 1, day 1 until 90 days after last dose (each cycle is 28 days) ]
    Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym). Scale from 0-168 obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life

  13. Assess pharmacokinetics (PK) of epcoritamab [ Time Frame: From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months) ]
    Total body clearance of drug from the plasma (CL)

  14. Assess pharmacokinetics (PK) of epcoritamab [ Time Frame: From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months) ]
    Maximum observed concentration (Cmax)

  15. Assess pharmacokinetics (PK) of epcoritamab [ Time Frame: From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months) ]
    Time to reach Cmax (Tmax)

  16. Assess pharmacokinetics (PK) of epcoritamab [ Time Frame: From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months) ]
    Terminal Elimination Half-Life (t 1/2)



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have newly diagnosed CD20+ large cell lymphoma.
  • Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to:

    • Being age ≥80 years; AND/OR
    • Being age ≥75 years and having important comorbid condition(s), which are likely to have a negative impact on tolerability of anthracycline-based therapy/cytotoxic chemotherapy.
  • Have Immune Effector Cell-Associated Encephalopathy (ICE) score of at least 8 out of 10.
  • Have Ann Arbor Stage II-IV disease.
  • Have ECOG PS of 0, 1, or 2; (ECOG PS of 3 may be considered if impairment is attributed to current lymphoma/DLBCL and if pre-phase treatment during the screening phase results in an improvement of ECOG PS to ≤2 prior to enrollment).
  • Have measurable disease as per Lugano criteria.
  • Have acceptable organ function based on baseline bloodwork.
  • Must have fresh (preferred) or archival biopsy material at screening.

Exclusion Criteria:

  • Has known active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection at trial enrollment, including COVID-19 infection.
  • Has severe cardiovascular disease (other than those eligibility criteria that preclude the subject from receiving anthracycline-based therapy/cytotoxic chemotherapy),
  • Has been exposed to/received any of the following prior therapies, treatments, or procedures within the specified timeframes:

    • Major surgery within 4 weeks prior to the first dose of epcoritamab;
    • Non-investigational antineoplastic agents (except anti-CD20 monoclonal antibodies) or any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab;
    • Autologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic stem cell transplantation, or solid organ transplantation;
    • Live, attenuated vaccines within 30 days prior to initiation of epcoritamab;
    • Investigational vaccines within 28 days before the planned first dose of epcoritamab (ie, experimental and/or non-authorized SARS-CoV-2 vaccinations and therapies are not allowed);
    • Invasive investigational medical device use within 28 days before the planned first dose of epcoritamab.
  • Has primary central nervous system (CNS) tumor or known CNS involvement or intracranial involvement as confirmed by mandatory brain magnetic resonance imaging/computed tomography (MRI/CT) scan at screening and, if clinically indicated, by lumbar puncture.
  • Has a seizure disorder requiring anti-epileptic therapy or experienced a seizure within 6 months of signing an informed consent form.
  • Has known past or current malignancy other than inclusion diagnosis, with exceptions as stated in protocol.
  • Has known or suspected allergies, hypersensitivity, or intolerance to either of the trial treatments or has known or suspected contraindication to the use of all locally available anti-cytokine therapies per local guidelines for management of cytokine release syndrome (CRS).
  • Has active hepatitis B virus (HBV) (DNA polymerase chain reaction [PCR]-positive) or hepatitis C virus (HCV) (RNA PCR-positive) infection, current alcohol abuse, or cirrhosis.
  • Has active cytomegalovirus (CMV) infection (DNA PCR-positive) requiring treatment.
  • Has suspected active or inadequately treated latent tuberculosis.
  • Has a known history of seropositivity for HIV. Note: HIV testing is required at screening only if required per local health authorities or institutional standards.

Note: Other protocol defined inclusion/exclusion criteria may apply.


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): NCT05660967


Contacts
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Contact: Genmab Trial Information +4570202728 ext +4570202728 clinicaltrials@genmab.com

Locations
Show Show 75 study locations
Sponsors and Collaborators
Genmab
AbbVie
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Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT05660967    
Other Study ID Numbers: GCT3013-06
2021-005744-29 ( EudraCT Number )
jRCT2021230015 ( Registry Identifier: Japan Registry for Clinical Trials (jRCT) )
1006219 ( Other Identifier: IRAS ID; UK Research Summaries Database )
2023-504832-16-00 ( EU Trial (CTIS) Number )
First Posted: December 21, 2022    Key Record Dates
Last Update Posted: June 4, 2024
Last Verified: June 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genmab:
Double-hit lymphoma
Triple-hit lymphoma
Follicular grade 3B
T-cell/histiocyte rich LBCL
DuoBody®
Anti-CD3
Anti-CD20
Subcutaneous
Bispecific antibody
EPCORE
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
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents