CTIS2022-501380-40-00招募中1 期
A Multicenter, Open-label, Phase 2 Dose Escalation and Confirmation, and Efficacy Expansion Study of Zilovertamab Vedotin (MK-2140) in Combination with R-CHP in Participants with DLBCL (waveLINE) - MK-2140-007
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) by prior biopsy, Has positron emission tomography (PET)-positive disease verified by blinded independent central review (BICR) at screening, defined as 4-5 on the Lugano response criteria 5-point scale, Has received no prior treatment for DLBCL, Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days prior to the start of study intervention
排除标准
- •Has a history of transformation of indolent disease to DLBCL, 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, Has received a strong inhibitor or inducer of CYP3A4 (including itraconazole, ketoconazole, posaconazole, or voriconazole) within 7 days prior to the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor until <30 days after the last dose, Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study intervention, Has known active central nervous system (CNS) lymphoma, Has an active infection requiring systemic therapy, Has a known history of human immunodeficiency virus (HIV) infection, Has a known active hepatitis C virus infection, Has a known active hepatitis B virus infection, Has received solid organ transplant at any time, Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL), Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class =II), or serious cardiac arrhythmia requiring medication, Has pericardial effusion or clinically significant pleural effusion, Has ongoing Grade >1 peripheral neuropathy, Has a demyelinating form of Charcot-Marie-Tooth disease, History of a second malignancy unless potentially curative treatment has been completed with no evidence of malignancy for 2 years with the exception of participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous-cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, Has received prior radiotherapy within 28 days of start of study intervention
研究者
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