A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-004)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 71
- 主要终点
- Objective Response Rate (ORR) per Lugano Response Criteria
研究概览
简要总结
The purpose of this study is to evaluate zilovertamab vedotin with respect to objective response rate and duration of response per Lugano Response Criteria as assessed by blinded independent central review (BICR). Safety and tolerability will also be evaluated in this Phase 2, single arm, interventional study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Has relapsed or refractory (rr) DLBCL; has progressed after at least 2 lines of prior therapy; and has progressed after auto- stem cell transplant (SCT) or are auto-SCT ineligible. Must have received prior multiagent regimen that includes an alkylating agent. anthracycline, and anti-CD20 (cluster of differentiation 20) monoclonal antibody.
- •Has histologically confirmed diagnosis of DLBCL.
- •Has radiographically measurable DLBCL per the Lugano Response Criteria.
- •Should either be post- chimeric antigen receptor T cell therapy (CAR-T) failure or ineligible for CAR-T (for any reason).
- •Life expectancy of at least 3 months.
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before time of enrollment.
- •Has adequate organ function.
排除标准
- •Has received a diagnosis of Primary mediastinal B-cell lymphoma (PMBCL).
- •Has undergone solid organ transplant at any time.
- •Has a history of any clinically significant cardiovascular conditions within 6 months of screening or serious cardiac arrhythmia requiring medication.
- •Has known history of liver cirrhosis.
- •Has pericardial effusion or clinically significant pleural effusion.
- •Has ongoing Grade >1 peripheral neuropathy.
- •Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- •Transformed DLBCL from indolent lymphoma.
- •In participants with prior allo-SCT, acute graft versus host disease (GVHD) or ongoing evidence of chronic GVHD.
- •Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.
- •Has received prior radiotherapy within 28 days of start of study intervention. Participants.
- •must have recovered from all radiation-related toxicities.
- •Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent).
- •Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- •Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
- •Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma.
- •Has an active infection requiring systemic therapy.
- •Has a known history of human immunodeficiency virus (HIV) infection.
- •Has a known history of hepatitis B or known active hepatitis C virus (HCV).
研究组 & 干预措施
Arm A
Participants will receive treatment with zilovertamab vedotin 2.5 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks (Q3W)) until documented disease progression or any other discontinuation criterion is met.
干预措施: Zilovertamab vedotin (Biological)
Arm B
Participants will receive treatment with zilovertamab vedotin 2.25 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks (Q3W)) until documented disease progression or any other discontinuation criterion is met.
干预措施: Zilovertamab vedotin (Biological)
结局指标
主要结局
Objective Response Rate (ORR) per Lugano Response Criteria
时间窗: Up to approximately 50 months
ORR is percentage of participants with complete response (CR) or partial response (PR). ORR by cohort, relapsed or refractory (rr) DLBCL as assessed by BICR according to Lugano Response Criteria 2014 in participants treated with zilovertamab vedotin Q3W. CR is the complete radiologic response. PR is a partial response, \>=50% decrease in sum of the product of the perpendicular diameters for multiple lesions for up to 6 target measurable nodes and extranodal sites.
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 50 months)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 50 months)
- Duration of Response (DOR) per Lugano Response Criteria(Up to approximately 50 months)