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)

• ClinicalTrials.gov Identifier: NCT05409066
• Recruitment Status: Recruiting
• First Posted: June 8, 2022
• Last Update Posted: May 7, 2024
• Sponsor: Genmab
• Collaborator: AbbVie
• Information provided by (Responsible Party): Genmab

Tracking Information

• First Submitted Date: June 3, 2022
• First Posted Date: June 8, 2022
• Last Update Posted Date: May 7, 2024
• Actual Study Start Date: September 20, 2022
• Estimated Primary Completion Date: November 15, 2029 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 3, 2022)

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 25, 2023)

• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: June 3, 2022)

• 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.
• 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.
• 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.
• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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)

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. Enrollment to one of the groups is closed. Around 500 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Follicular Lymphoma (FL)

Intervention

• Drug: Epcoritamab
  Subcutaneous Injection
  Other Name: GEN3013
• Drug: Rituximab
  Intravenous Infusion
• Drug: Lenalidomide
  Oral Capsules

Study Arms

• 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).
  Interventions:

  • Drug: Epcoritamab
  • Drug: Rituximab
  • Drug: Lenalidomide
• 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). Enrollment is closed for this arm.
  Interventions:

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

  • Drug: Rituximab
  • Drug: Lenalidomide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 27, 2023): 500
• Original Estimated Enrollment (submitted: June 3, 2022): 642
• Estimated Study Completion Date: June 16, 2030
• Estimated Primary Completion Date: November 15, 2029 (Final data collection date for primary outcome measure)

Eligibility 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) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI.
• Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent 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 chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.)
• Eligible to receive R2 per investigator determination.
• Estimated Creatinine Clearance (CrCl) >= 50 mL/min.

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Puerto Rico, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
• Removed Location Countries: Russian Federation, Ukraine

Administrative Information

• NCT Number: NCT05409066
• Other Study ID Numbers: M20-638; 2021-000169-34 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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/

• Current Responsible Party: Genmab
• Original Responsible Party: AbbVie
• Current Study Sponsor: Genmab
• Original Study Sponsor: AbbVie
• Collaborators: AbbVie

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: Genmab
• Verification Date: May 2024