2022-501243-33-00招募中2 期
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
- 招募中
- 入组人数
- 59
- 试验地点
- 24
- 主要终点
- Objective Response Rate (ORR) per Lugano Response Criteria
研究概览
简要总结
To evaluate zilovertamab vedotin with respect to objective response rate per Lugano Response Criteria as assessed by Blinded Independent Central Review (BICR)
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
- 是
入选标准
- •Has relapsed or refractory (rr) diffuse large B-cell lymphoma diffused large B-cell lymphoma (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 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)
- •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
结局指标
主要结局
Objective Response Rate (ORR) per Lugano Response Criteria
Objective Response Rate (ORR) per Lugano Response Criteria
次要结局
- Duration of Response (DOR) per Lugano Response Criteria 1
- Number of Participants Who Experience an Adverse Event (AE)
- Number of Participants Who Discontinue Study Treatment Due to an AE
研究者
Nishitha Reddy
Scientific
Merck Sharp & Dohme LLC
研究点 (24)
Loading locations...
相似试验
招募中
1/2 期
LIGHTBEAM-U01-Substudy 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants with Hematologic Malignancies or Solid Tumors.2023-507178-41-00Merck Sharp & Dohme LLC50
招募中
3 期
A clinical study of zilovertamab vedotin in people with large B-cell lymphoma (MK-2140-010)2024-515566-13-00Merck Sharp & Dohme LLC265
招募中
2 期
A study to learn more about how well treatment with sevabertinib (BAY2927088) tablets works and how safe it is in participants who have a solid tumor with mutations of the human epidermal growth factor receptor 2 (HER2)2024-517419-62-00Bayer Consumer Care AG, Bayer AG37
撤回
2 期
A Study of Disitamab Vedotin Alone and with Pembrolizumab in Urothelial Cancer That Expresses HER22022-500030-28-00Seagen Inc.68
招募中
2 期
A clinical study of zilovertamab vedotin with R-CHP treatment in people with diffuse large B-cell lymphoma (MK-2140-011)2024-515526-89-00Merck Sharp & Dohme LLC240