2022-502660-20-00招募中3 期
A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO COMPARE THE EFFICACY AND SAFETY OF ODRONEXTAMAB (REGN1979), AN ANTI-CD20 X ANTI-CD3 BISPECIFIC ANTIBODY, VERSUS INVESTIGATOR’S CHOICE IN PREVIOUSLY UNTREATED PARTICIPANTS WITH FOLLICULAR LYMPHOMA (OLYMPIA-1)
Regeneron Pharmaceuticals Inc.96 个研究点 分布在 5 个国家目标入组 225 人开始时间: 2023年10月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 225
- 试验地点
- 96
- 主要终点
- Part 1: Incidence of dose-limiting toxicities (DLTs) for odronextamab
研究概览
简要总结
Part 1 (Safety Run-in): Assess the safety, tolerability, and dose-limiting toxicities (DLTs) of odronextamab in participants with previously untreated follicular lymphoma (FL)
Part 2 (Randomized Phase): To compare the efficacy of odronextamab versus investigator’s choice chemotherapy in participants with previously untreated FL as measured by complete response 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
- •Diagnoses of cluster of differentiation 20^+ (CD20^+) FL Grade 1-3a, stage II bulky or stage III / IV
- •Need for treatment as described in the protocol
- •Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed tomography (CT) or Magnetic resonance imaging (MRI)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Adequate bone marrow function and hepatic function
- •NOTE: Other protocol defined inclusion criteria apply
排除标准
- •Central nervous system (CNS) lymphoma or leptomeningeal lymphoma
- •Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- •Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
- •Treatment with any systemic anti-lymphoma therapy
- •Infections and allergy/hypersensitivity to study drug or excipient
- •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
Part 1: Incidence of dose-limiting toxicities (DLTs) for odronextamab
Part 1: Incidence of treatment-emergent adverse events (TEAEs) of odronextamab
Part 1: Incidence of treatment-emergent adverse events (TEAEs) of odronextamab
Part 1: Severity of TEAEs of odronextamab
Part 1: Severity of TEAEs of odronextamab
Part 2: Complete Response at 30 months (CR30) as assessed by independent central review
Part 2: Complete Response at 30 months (CR30) as assessed by independent central review
次要结局
- Part 1: Concentrations of odronextamab in serum
- Part 1:Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration
- Part 1: Titer of ADAs to odronextamab over the study duration
- Part 1: Incidence of neutralizing antibodies (NAbs) to odronextamab over the study duration
- Part 1: Objective response as assessed by the investigator
- Part 2: Progression-free survival (PFS) as assessed by independent central review
- Part 2: Event-free survival (EFS) as assessed by independent central review
- Part 2: CR30 as assessed by local investigator
- Part 2: Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)]
- Part 2: PFS as assessed by the local investigator
- Part 2: EFS as assessed by the local investigator
- Part 2: Overall survival (OS)
- Part 2: Objective response assessed by local investigator
- Part 2: Objective response assessed by independent central review
- Part 2: Duration of response (DOR) assessed by independent central review
- Part 2: DOR 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: Odronextamab concentrations in serum during the induction period
- Part 2: Odronextamab concentrations in serum during the maintenance period
- Part 2: Incidence of ADAs to odronextamab over the study duration
- Part 2: Titer of ADAs to odronextamab over the study duration
- Part 2: Incidence of NAbs to odronextamab over the study duration
- Part 2: Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30
- Part 2: Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy–Lymphoma (FACT-LymS)
- Part 2: Overall mean changes in scores of PROs, as measured by the validated instruments Patient Global Impression of Severity (PGIS)
- Part 2: Overall mean changes in scores of PROs, as measured by the validated instruments Patient Global Impression of Change (PGIC)
- Part 2: Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L)
- Part 2: Change in score of the global population 5 (GP5) item of the validated Functional Assessment of Cancer - General (FACT-G) questionnaire
研究者
Head of EU Regulatory Affairs
Scientific
Regeneron Pharmaceuticals Inc.
研究点 (96)
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