Clinical Trial 23643

• Overview

  Study 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)

  Summary:

  The purpose of this study is to see if the combination of the investigational drug epcoritamab with rituximab and lenalidomide has a better response rate and the cancer does not worsen compared to standard of care chemoimmunotherapy in the treatment of follicular lymphoma.

  Objective:

  Primary Objective(s): to demonstrate that epcoritamab with R2 (ER2) will improve CR30 rates and PFS using Lugano criteria by IRC compared to chemoimmunotherapy (CIT) in subjects with previously untreated FL. To assess the efficacy of Arm A1 (ER2 + E Maintenance) compared to Arm B (CIT + anti CD20 maintenance) in subjects with previously untreated FL. Secondary Objective(s): to compare, between treatment arms (where applicable), the following: Key Secondary Endpoints in Arm A1 versus Arm B: OS. PROs: Change from baseline in physical functioning at Week 21 for Arm A1 and Week 21/22 for Arm B as assessed by the EORTC QLQ-C30 physical functioning scale. MRD negativity rate.

• Treatments

  Therapies:

  CD20 monoclonal antibody; Chemoimmunotherapy; Humanized IgG1-bispecific antibody; Immunomodulators; Immunotherapy

  Medications:

  Adriamycin (doxorubicin); Bendamustine (); CC-5013 (Lenalidomide); Epcoritamab (); GEN3013 (Epcoritamab); Lenalidomide (Revlimid); Obinutuzumab (); Rituxan (rituximab); Vincristine (); cyclophosphamide (); cytoxan (cyclophosphamide); doxorubicin (); prednisone (); rituximab ()

• Inclusion Criteria

  Inclusion Criteria:
  • 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.
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • Had major surgery within 4 weeks prior to randomization.
  • Have active cytomegalovirus (CMV) disease.
  • Other exclusions may apply

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