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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 822
- 试验地点
- 365
- 主要终点
- Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab
研究概览
简要总结
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 (a type of non-Hodgkin lymphoma or NHL).
This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled).
The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone.
The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") 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)
- How the study drug affects quality of life and ability to complete routine daily activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis 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, as described in the protocol
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, as described in the protocol
- •NOTE: Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Rituximab + Investigator's Choice Chemotherapy
Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.
干预措施: Rituximab (Drug)
Rituximab + Investigator's Choice Chemotherapy
Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.
干预措施: Doxorubicin (Drug)
Rituximab + Investigator's Choice Chemotherapy
Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.
干预措施: Vincristine (Drug)
Rituximab + Investigator's Choice Chemotherapy
Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.
干预措施: Bendamustine (Drug)
Odronextamab
Part 1 is a safety run-in. All participants will receive odronextamab.
In part 2 participants will be randomly assigned in a 1:1 ratio to receive odronextamab followed by odronextamab maintenance.
干预措施: Odronextamab (Drug)
Rituximab + Investigator's Choice Chemotherapy
Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.
干预措施: Cyclophosphamide (Drug)
Rituximab + Investigator's Choice Chemotherapy
Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.
干预措施: Prednisone/prednisolone (Drug)
结局指标
主要结局
Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab
时间窗: Up to 35 days
Part 1
Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamab
时间窗: Up to 2 years
Part 1
Severity of TEAEs of odronextamab
时间窗: Up to 2 years
Part 1
Complete Response at 30 months (CR30) as assessed by independent central review
时间窗: Up to 30 months
Part 2
Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab
时间窗: Up to 35 days
Part 1
Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamab
时间窗: Up to 2 years
Part 1
Severity of TEAEs of odronextamab
时间窗: Up to 2 years
Part 1
Complete Response at 30 months (CR30) as assessed by independent central review
时间窗: Up to 30 months
Part 2
次要结局
- Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L)(Up to 5 years)
- Change in score of the GP5 item in the participant population(Up to 5 years)
- Progression-Free Survival (PFS) as assessed by independent central review(Up to 5 years)
- Event-Free Survival (EFS) as assessed by independent central review(Up to 5 years)
- Overall Survival (OS)(Up to 5 years)
- Duration Of Response (DOR) assessed by independent central review(Up to 5 years)
- Time To Next anti-lymphoma Treatment (TTNT)(Up to 5 years)
- Change in Patient Global Impression of Severity (PGIS)(Up to 5 years)
- Change in Patient Global Impression of Change (PGIC)(Up to 5 years)
- Incidence of TEAEs(Up to 2 years)
- Severity of TEAEs(Up to 2 years)
- Odronextamab concentrations in serum during the induction period(Up to 30 months)
- Odronextamab concentrations in serum during the maintenance period(Up to 30 months)
- Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30(Up to 5 years)
- Concentrations of odronextamab in serum(Up to 30 months)
- Objective response as assessed by the investigator(Up to 30 months)
- CR30 as assessed by local investigator(Up to 30 months)
- Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)](Up to 5 years)
- PFS as assessed by the local investigator(Up to 5 years)
- EFS as assessed by the local investigator(Up to 5 years)
- Objective response assessed by local investigator(Up to 30 months)
- Objective response assessed by independent central review(Up to 30 months)
- DOR assessed by local investigator(Up to 5 years)
- Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS)(Up to 5 years)
- Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L)(Up to 5 years)
- Change in score of the GP5 item in the participant population(Up to 5 years)
- Concentrations of odronextamab in serum(Up to 30 months)
- Incidence of Anti-Drug Antibodies (ADAs) to odronextamab over the study duration(Up to 30 months)
- Magnitude of ADAs to odronextamab over the study duration(Up to 30 months)
- Objective response as assessed by the investigator(Up to 30 months)
- Progression-Free Survival (PFS) as assessed by independent central review(Up to 5 years)
- Event-Free Survival (EFS) as assessed by independent central review(Up to 5 years)
- Overall Survival (OS)(Up to 5 years)
- Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)](Up to 5 years)
- CR30 as assessed by local investigator(Up to 30 months)
- PFS as assessed by the local investigator(Up to 5 years)
- EFS as assessed by the local investigator(Up to 5 years)
- Objective response assessed by local investigator(Up to 30 months)
- Objective response assessed by independent central review(Up to 30 months)
- Duration Of Response (DOR) assessed by independent central review(Up to 5 years)
- DOR assessed by local investigator(Up to 5 years)
- Time To Next anti-lymphoma Treatment (TTNT)(Up to 5 years)
- Incidence of TEAEs(Up to 2 years)
- Severity of TEAEs(Up to 2 years)
- Odronextamab concentrations in serum during the induction period(Up to 30 months)
- Odronextamab concentrations in serum during the maintenance period(Up to 30 months)
- Incidence of ADAs to odronextamab over the study duration(Up to 30 months)
- Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30(Up to 5 years)
- Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS)(Up to 5 years)
- Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L)(Up to 5 years)
- Change in Patient Global Impression of Severity (PGIS)(Up to 5 years)
- Change in Patient Global Impression of Change (PGIC)(Up to 5 years)
- Change in score of the GP5 item in the participant population(Up to 5 years)
- Occurrence of Anti-Drug Antibodies (ADAs) to odronextamab(Up to 30 months)
- Magnitude of ADAs to odronextamab(Up to 30 months)
- Occurrence of ADAs to odronextamab(Up to 30 months)