A Phase 3, Open Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Combination with Lenalidomide Versus Rituximab in Combination with Lenalidomide in Relapsed/Refractory Participants with Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 232
- 试验地点
- 87
- 主要终点
- Part 1: Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with lenalidomide
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 combination with lenalidomide in participants with relapsed/refractory (R/R) indolent lymphoma (FL and MZL).
Part 2 (Randomized Phase) To compare the efficacy of odronextamab in combination with lenalidomide versus rituximab in combination with lenalidomide (R2) in participants with R/R FL and subsequently in participants with indolent lymphoma (combined R/R FL and marginal zone lymphoma (MZL)) as measured by progression-free survival (PFS) 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（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator, as described in the protocol.
- •Have refractory disease or relapsed after at least one prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-cluster of differentiation 20 (CD20) monoclonal antibody and participant should meet indication for treatment as described in the protocol.
- •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 to
- •Adequate hematologic and organ function, as described in the protocol.
- •All study participants must: a. Have an understanding that lenalidomide could have a potential teratogenic risk. b. Agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of lenalidomide. c. Agree not to share study medication with another person. d. Agree to be counseled about pregnancy precautions and risk of fetal exposure associated with lenalidomide.
- •Note: Other protocol-defined Inclusion criteria apply
排除标准
- •Primary central nervous system (CNS) lymphoma or known involvement (either current or prior history of CNS involvement) by non-primary CNS Non-Hodgkin lymphoma (NHL), as described in the protocol.
- •Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma, or any histology other than FL grade 1-3a or MZL.
- •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 treated with hormone therapy or local radiotherapy (ie, pellets), 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.
- •Allergy/hypersensitivity to study drugs or excipients, as described in the protocol.
- •Active infection as defined 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 lenalidomide
Part 1: Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with lenalidomide
Part 1: Incidence of treatment emergent adverse events (TEAEs) for odronextamab in combination with lenalidomide
Part 1: Incidence of treatment emergent adverse events (TEAEs) for odronextamab in combination with lenalidomide
Part 1: Severity of TEAEs for odronextamab in combination with lenalidomide
Part 1: Severity of TEAEs for odronextamab in combination with lenalidomide
Part 2: Progression-free survival (PFS) as assessed by independent central review (ICR) in participants with R/R FL and participants with indolent lymphoma (FL and MZL)
Part 2: Progression-free survival (PFS) as assessed by independent central review (ICR) in participants with R/R FL and participants with indolent lymphoma (FL and MZL)
次要结局
- Part 1 & 2: Odronextamab concentrations in serum
- Part 1 & 2: Incidence of anti-drug antibodies (ADA) to odronextamab over the study duration
- Part 1 & 2: Titer of ADAs to odronextamab over the study duration
- Part 1 & 2: Incidence of neutralizing antibodies (NAbs) to odronextamab over the study duration
- Part 1 & 2: Best overall response (BOR) as assessed by investigator review
- Part 1 & 2: Duration of response (DOR) as assessed by investigator review
- Part 1 & 2: PFS as assessed by investigator review
- Part 2: Complete response (CR) as assessed by ICR
- Part 2: BOR as assessed by ICR
- Part 2: Overall survival (OS)
- Part 2: Event free survival (EFS) as assessed by ICR
- Part 2: EFS as assessed by local investigator review
- Part 2: DOR as assessed by ICR
- Part 2: Time to next anti-lymphoma treatment (TTNT)
- Part 2: Incidence of TEAEs for odronextamab in combination with lenalidomide versus R2
- Part 2: Severity of TEAEs for odronextamab in combination with lenalidomide versus R2
- Part 2: Overall change in patient reported outcomes (PROs) as measured by scores of European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQC30)
- Part 2: Overall change in PROs as measured by scores of Functional Assessment of Cancer Therapy–Lymphoma Subscale (FACT-LymS)
- Part 2: Overall change in PROs as measured by scores of Patient Global Impression on Severity (PGIS)
- Part 2: Overall change in PROs as measured by scores of Patient Global Impression on Change (PGIC)
- Part 2: Overall change in PROs as measured by scores of EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L)
- Part 2: Overall change in score of the global population item 5 (GP5) items of the Functional Assessment of Cancer Therapy–General (FACT-G) questionnaire
研究者
Head EU Regulatory Affairs
Scientific
Regeneron Pharmaceuticals Inc.