A Phase 3, Open-Label, Randomized Study To Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Combined with Chemotherapy versus Rituximab Combined with Chemotherapy in Previously Untreated Participants with Follicular Lymphoma (OLYMPIA-2)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 87
- 主要终点
- Part 1: Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with chemotherapy
研究概览
简要总结
Part 1 Assess the safety, tolerability, and dose limiting toxicities (DLTs) of odronextamab in combination with chemotherapy in participants with previously untreated follicular lymphoma (FL) and participants with relapsed or refractory (R/R) FL (Part 1A only), and to determine an optimal dosing regimen of odronextamab (Part 1B) in previously untreated participants with FL to combine with CHOP/CVP in Part 2.
Part 2 To compare the efficacy of odronextamab in combination with chemotherapy versus rituximab in combination with chemotherapy in participants with previously untreated FL as measured by complete response rate at 30 months (CR30) per independent central review.
研究设计
- 分配方式
- Randomized
- 主要目的
- Part 2 Randomised Phase
- 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
- •Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV
- •Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Adequate bone marrow and hepatic function
- •NOTE: Other protocol defined inclusion criteria apply
排除标准
- •Participants with central nervous system lymphoma or leptomeningeal lymphoma
- •Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- •Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma
- •Recent major surgery and history or organ transplantation
- •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 exclusion criteria apply
结局指标
主要结局
Part 1: Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with chemotherapy
Part 1: Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with chemotherapy
Part 1: Incidence of treatment-emergent adverse events (TEAEs) of odronextamab in combination with chemotherapy
Part 1: Incidence of treatment-emergent adverse events (TEAEs) of odronextamab in combination with chemotherapy
Part 1: Severity of treatment-emergent adverse events (TEAEs) of odronextamab in combination with chemotherapy
Part 1: Severity of treatment-emergent adverse events (TEAEs) of odronextamab in combination with chemotherapy
Part 2: Complete Response rate at 30 months (CR30) assessed by independent central review (ICR)
Part 2: Complete Response rate at 30 months (CR30) assessed by independent central review (ICR)
次要结局
- Part 1 and 2: Odronextamab concentrations in serum when administered with chemotherapy
- Part 1 and 2: Odronextamab concentrations in serum when administered as monotherapy
- Part 1 and 2: Incidence of anti-odronextamab antibodies (ADAs)
- Part 1 and 2: Titers of ADAs to odronextamab
- Part 1 and 2: Incidence of neutralizing antibodies (NAb) to odronextamab
- Part 1: Best overall response (BOR) as assessed by the investigator
- Part 2: Progression free survival (PFS) as assessed by ICR
- Part 2: Event-free survival (EFS) as assessed by ICR
- Part 2: CR30 as assessed by local investigator
- Part 2: Change in patient reported physical functioning scale scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC-QLQ-C30)
- Part 2: PFS as assessed by local investigator
- Part 2: EFS as assessed by local investigator
- Part 2: Overall Survival (OS)
- Part 2: Best Overall response (BOR) as assessed by local investigator
- Part 2: BOR as assessed by ICR
- Part 2: Duration of response (DOR) assessed by ICR
- Part 2: DOR as assessed by local investigator
- Part 2: Time to next anti-lymphoma treatment (TTNT)
- Part 2: Incidence of TEAEs
- Part 2: Severity of TEAEs
- Part 2: Change in patient reported health related quality of life (HRQoL) as measured by EORTC-QLQ-C30
- Part 2: Change in cancer disease as measured by EORTC-QLQ-C30
- Part 2: Change in treatment related symptoms as measured by EORTC-QLQ-C30
- Part 2: Change in patient-reported lymphoma disease as measured by the Lymphoma Subscale of the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS)
- Part 2: Change in treatment-related symptoms as measured by the FACT-LymS
- Part 2: Change in patient-reported general health status per EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
- Part 2: Change in patient-reported treatment side effects burden per Functional Assessment of Cancer Therapy–General Global Population Item 5 (FACT-5 GP5)
- Part 2: Change in Patient Global Impression of Severity (PGIS)
- Part 2: Change in Patient Global Impression of Change (PGIC)
- Part 2: Change in score of the FACT-G GP5 item in the patient population
研究者
Head EU Regulatory
Scientific
Regeneron Pharmaceuticals Inc.