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 Previously Untreated Follicular Lymphoma

NCT06191744
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,095
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Lead sponsor
Genmab
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Start date
2024-02-05
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Number of sites
266
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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 previously untreated 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 5 groups, called treatment arms. Each group receives a different treatment. Around 1095 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world. Participants will receive R2 (intravenous \[IV\] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) \[G-CHOP\]/ R-CHOP or G and IV infusion of bendamustine (Benda) \[G-Benda\]/R-Benda. The total treatment duration will be 120 weeks for all arms except A2, which is 24 weeks of treatment. 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.
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Acronym
EPCORE™FL-2
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Short 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 Previously Untreated Follicular Lymphoma
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Official title
A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2037-11-01
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First posted
2024-01-05
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Registry last updated
2026-08-04
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Primary completion date
2037-11-01
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Start date
2024-02-05
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Actual participants
1,095
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Participants
1,095
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
266
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Genmab
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06191744
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ClinicalTrials.gov ID
NCT06191744
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Arm A1 vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)

    Timeframe: Up to 30 Months

    CR30 will be determined by positron emission tomography-computerized tomography (cat scan) \[PET-CT\] per Lugano 2014 criteria, as assessed by independent review committee (IRC).

  2. Arm A1 vs Arm B: Number of Participants with Progression-free survival (PFS)

    Timeframe: Up to 10 Years

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

  1. Arm A1 vs Arm B: Overall Survival (OS)

    Timeframe: Up to 10 Years

    OS is defined as the time from the date of randomization to the date of death of any cause.

  2. Arm A1 vs Arm B: Rate of Minimal Residual Disease (MRD) Negativity Rate

    Timeframe: Up to 10 Years

    MRD negativity rate, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with follicular lymphoma (FL) MRD at baseline.

  3. Arm A1 vs Arm B: Change from Baseline in Physical Functioning (PF) According to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30)

    Timeframe: 21 Weeks

    The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.

  4. Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30

    Timeframe: Up to 30 Months

    CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

  5. Arm A1 vs Arm C: Percentage of Participants who Achieve CR30

    Timeframe: Up to 30 Months

    CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

  6. Arm A1 vs Arm A2: Number of Participants with PFS

    Timeframe: Up to 10 Years

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

  7. Arm A1 vs Arm C: Number of Participants with PFS

    Timeframe: Up to 10 Years

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

  8. Arm A1 vs Arm A2: Rate of MRD Negativity

    Timeframe: Up to 10 Years

    MRD negativity, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with FL MRD at baseline.

  9. Arm A1 vs Arm C: Rate of MRD Negativity

    Timeframe: Up to 10 Years

    MRD negativity, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with FL MRD at baseline.

  10. Arm A1 vs Arm A2: Change from Baseline in PF According to EORTC QLQ-C30

    Timeframe: Up to 10 Years

    The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.

  11. Arm A1 vs Arm C: Change from Baseline in PF According to EORTC QLQ-C30

    Timeframe: Up to 10 Years

    The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.

  12. Arm A1 vs Arm A2: OS

    Timeframe: Up to 10 Years

    OS is defined as the time from the date of randomization to the date of death of any cause.

  13. Arm A1 vs Arm C: OS

    Timeframe: Up to 10 Years

    OS is defined as the time from the date of randomization to the date of death of any cause.

  14. Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30

    Timeframe: Up to 30 Months

    CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

  15. Arm A1 vs Arm B: Percentage of Participants who Achieve CR30

    Timeframe: Up to 30 Months

    CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

  16. Arm A1 vs Arm C: Percentage of Participants who Achieve CR30

    Timeframe: Up to 30 Months

    CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

  17. Arm A1 vs Arm A2: Number of Participants with PFS

    Timeframe: Up to 10 Years

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.

  18. Arm A1 vs Arm B: Number of Participants with PFS

    Timeframe: Up to 10 Years

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.

  19. Arm A1 vs Arm C: Number of Participants with PFS

    Timeframe: Up to 10 Years

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.

  20. Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per IRC

    Timeframe: Up to 10 Years

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

  21. Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per Investigator

    Timeframe: Up to 10 Years

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

  22. Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per IRC

    Timeframe: Up to 10 Years

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

  23. Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per Investigator

    Timeframe: Up to 10 Years

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

  24. Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per IRC

    Timeframe: Up to 10 Years

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

  25. Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per Investigator

    Timeframe: Up to 10 Years

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

And 69 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Diagnosis of follicular lymphoma (FL).

  • Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.

  • Are willing and able to comply with procedures required in the protocol.

  • Must have stage, III, IV or II with bulky disease >= 7cm).

  • Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.

  • Has one or more target lesions:

    • A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and
    • >=1 measurable nodal lesion (long axis >1.5cm) or >=1 measurable extra-nodal lesion (long axis >1.0 cm) on CT scan or MRI

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

  • Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: [Arm B] at the discretion of the Investigator, and rituximab and lenalidomide (R2) [Arm C].

  • Have laboratory values meeting the criteria in the protocol.

  • Had major surgery within 4 weeks prior to randomization.
  • Have active cytomegalovirus (CMV) disease.
Sources for eligibility
clinicaltrials.gov

  • UCSF Fresno /ID# 264712Fresno, United States
  • Scripps Mercy Hospital /ID# 265393San Diego, United States
  • Sansum Clinic Research /ID# 261596Santa Barbara, United States
  • Rocky Mountain Cancer Centers - Boulder /ID# 261203Boulder, United States
  • Christiana Care Health Service /ID# 261207Newark, United States
  • Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445Jacksonville, United States
  • Advent Health /ID# 261578Orlando, United States
  • Orlando Health Cancer Institute /ID# 260983Orlando, United States
  • Moffitt Cancer Center /ID# 259487Tampa, United States
  • Beacon Cancer Care - Coeur d'Alene /ID# 260670Coeur d'Alene, United States
  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 259814Chicago, United States
  • Cancer Care Specialists Of Central Illinois /ID# 272464Decatur, United States
  • Loyola University /ID# 259462Maywood, United States
  • Illinois Cancer Care, PC /ID# 261526Peoria, United States
  • Fort Wayne Medical Oncology and Hematology- South Office /ID# 259583Fort Wayne, United States
  • University of Iowa Health Care /ID# 262132Des Moines, United States
  • University of Louisville Hospital /ID# 260544Louisville, United States
  • Norton Cancer Institute - St. Matthews /ID# 261076Louisville, United States
  • New England Cancer Specialists - Westbrook /ID# 260672Westbrook, United States
  • University of Maryland, Baltimore /ID# 259538Baltimore, United States
  • Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 259476Bethesda, United States
  • St. Luke's Hospital - Chesterfield /ID# 260489Chesterfield, United States
  • Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 260006Billings, United States
  • Nebraska Cancer Specialists (NCS) - Regional Cancer Center - St Francis Location /ID# 262506Grand Island, United States
  • Nebraska Hematology-Oncology /ID# 269692Lincoln, United States

And 241 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-506906-38-00
Sources for references
clinicaltrials.gov

Related records

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Collaborators (1)

Lead sponsors (1)

Conditions (3)

Targets (25)