2022-502783-21-00招募中3 期
A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, versus Standard of Care Therapy in Participants with Relapsed/Refractory Aggressive B-cell non-Hodgkin Lymphoma (OLYMPIA-4)
Regeneron Pharmaceuticals Inc.26 个研究点 分布在 10 个国家目标入组 132 人开始时间: 2023年9月11日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 26
- 主要终点
- Event-free survival (EFS) as assessed by independent central review (ICR)
研究概览
简要总结
To compare the efficacy, as defined by EFS, in participants treated with odronextamab versus participants treated with Standard of Care (SOC)
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically proven aggressive B-NHL, as described in the protocol. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed.
- •Have primary refractory or relapse 12 months or less (≤) from initiation of frontline therapy. Only patients who received 1 prior line of therapy containing an anti-Cluster of Differentiation 20 (CD20) antibody and anthracycline are allowed for enrollment
- •Have measurable disease with at least one nodal lesion with longer diameter (LDi) greater than 1.5 cm or at least one extranodal lesion with LDi greater than 1.0 cm, documented by diagnostic imaging (computed tomography [CT] or magnetic resonance imaging [MRI])
- •Intent to proceed to autologous stem cell transplant (ASCT), as described in the protocol
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Adequate hematologic and organ function.
- •Other protocol defined inclusion criteria apply
排除标准
- •Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL, as described in the protocol
- •History of or current relevant CNS pathology, as described in the protocol
- •A malignancy other than NHL unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated
- •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
- •Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol
- •Allergy/hypersensitivity to study drug, or excipients.
- •Other protocol defined exclusion criteria apply
结局指标
主要结局
Event-free survival (EFS) as assessed by independent central review (ICR)
Event-free survival (EFS) as assessed by independent central review (ICR)
次要结局
- Progression free survival (PFS) as assessed by ICR
- Best overall response (BOR) as assessed by ICR
- Overall survival (OS)
- Overall change in physical functioning as measured by scores of the physical function scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30)
- EFS as assessed by local investigator
- PFS as assessed by local investigator
- BOR as assessed by local investigator
- Complete response (CR) assessed by ICR and local investigator
- Duration of response (DOR) assessed by ICR and local investigator
- Incidence of treatment-emergent adverse events (TEAEs)
- Severity of TEAEs
- Odronextamab concentrations in serum
- Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration
- Titers of ADAs to odronextamab over the study duration
- Incidence of neutralizing antibodies (NAb) to odronextamab over the study duration
- Measurable residual disease (MRD) status
- Overall change in patient-reported outcomes (PROs), as measured by scores of the EORTCQLQ- C30
- Overall change in PROs, as measured by scores of the Functional Assessment of Cancer Therapy–Lymphoma (FACT-LymS)
- Overall change in PROs, as measured by scores of the EuroQol-5 Dimension-5 Level Scale (EQ-5D-5L)
- Overall change in score of the Global Population item 5 (GP5) of the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire
研究者
Head EU Regulatory Affairs
Scientific
Regeneron Pharmaceuticals Inc.
研究点 (26)
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