A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma

Purpose

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with follicular lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory") are eligible to take part only in Part 1A of the study. This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled). The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy to be used in Part 2 of the study. The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab and chemotherapy (the current standard-of-care for NHL). Standard-of-care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) - The impact from the study drug on quality-of-life and ability to complete routine daily activities

Condition

  • Follicular Lymphoma (FL)

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV 1. For Part 1A: previously untreated participants who have Follicular Lymphoma International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL 2. For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5 3. For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5 2. Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 4. Adequate bone marrow and hepatic function.

Exclusion Criteria

  1. Participants with central nervous system lymphoma or leptomeningeal lymphoma 2. Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma 3. Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma 4. Recent major surgery and history or organ transplantation 5. A malignancy other than NHL unless the participant is adequately and definitively treated and any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol. Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Odronextamab + Chemotherapy 		Part 1 of the study includes ordonextamab dose escalation for participants with previously untreated FL and relapsed/refractory FL (Part 1A only) followed by a randomized exploration of 2 regimens of odronextamab (Odro) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) with the objective of dose optimization (Part 1B) in previously untreated patients with FL.
  • Drug: Odronextamab
    Administered by intravenous (IV) infusion
    Other names:
    • REGN1979
  • Drug: Cyclophosphamide
    Administered by IV infusion
    Other names:
    • Cytoxan
  • Drug: Doxorubicin
    Administered by IV infusion
    Other names:
    • Adriamycin
  • Drug: Prednisone/Prenisolone
    Administered orally (PO)
    Other names:
    • Deltasone/Omnipred
Active Comparator
Rituximab + Chemotherapy 		In Part 2 only, participants will be randomized 1:1:1 to receive rituximab (R) with chemotherapy (CHOP), followed by rituximab monotherapy maintenance.
  • Drug: Odronextamab
    Administered by intravenous (IV) infusion
    Other names:
    • REGN1979
  • Drug: Rituximab
    Administered by IV infusion, or subcutaneous (SC)
    Other names:
    • Rituxan
  • Drug: Cyclophosphamide
    Administered by IV infusion
    Other names:
    • Cytoxan
  • Drug: Doxorubicin
    Administered by IV infusion
    Other names:
    • Adriamycin
  • Drug: Vincristine
    Administered by IV infusion
    Other names:
    • Oncovin
  • Drug: Prednisone/Prenisolone
    Administered orally (PO)
    Other names:
    • Deltasone/Omnipred
Experimental
Odronextamab + Chemotherapy + Maintenance 		In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy [CHOP, or cyclophosphamide, vincristine, and prednisone (CVP)], followed by odronextamab monotherapy maintenance.
  • Drug: Odronextamab
    Administered by intravenous (IV) infusion
    Other names:
    • REGN1979
  • Drug: Vincristine
    Administered by IV infusion
    Other names:
    • Oncovin
Experimental
Odronextamab + Chemotherapy + No maintenance 		In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy (CHOP, or CVP) without maintenance.
  • Drug: Odronextamab
    Administered by intravenous (IV) infusion
    Other names:
    • REGN1979
  • Drug: Vincristine
    Administered by IV infusion
    Other names:
    • Oncovin

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536

More Details

NCT ID
NCT06097364
Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com