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.
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).
Had major surgery within 4 weeks prior to randomization.
Have active cytomegalovirus (CMV) disease.
Parallel
Epcoritamab
DrugSubcutaneous (SC) Injection
Prednisone
DrugOral Tablet
Rituximab
DrugIntravenous (IV) Infusion
Lenalidomide
DrugOral Capsule
Doxorubicin
DrugIV Injection
Vincristine
DrugIV Injection
Cyclophosphamide
DrugIV Injection
Obinutuzumab
DrugIV Infusion
Bendamustine
DrugIV Infusion
Arm A1 vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)
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).
Arm A1 vs Arm B: Number of Participants with Progression-free survival (PFS)
PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
Arm A1 vs Arm B: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death of any cause.
Arm A1 vs Arm B: Rate of Minimal Residual Disease (MRD) Negativity Rate
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.
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)
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.
Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30
CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.
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Genmab
Lead sponsor
AbbVie
Collaborator
