2022-501380-40-00招募中2 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)
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 11
- 主要终点
- Number of Participants Who Experienced Dose-limiting Toxicities (DLTs) in Cycle 1
研究概览
简要总结
- To evaluate the safety and tolerability and to establish a RP2D of zilovertamab vedotin when used in combination with R-CHP.
- To evaluate zilovertamab vedotin at the RP2D in combination with R-CHP with respect to complete response rate per Lugano response as assessed by the investigator.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Dose Escalation Part 1
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Number of Participants Who Experienced Dose-limiting Toxicities (DLTs) in Cycle 1
Number of Participants Who Experienced Dose-limiting Toxicities (DLTs) in Cycle 1
Number of Participants Who Experienced At Least One Adverse Event (AE)
Number of Participants Who Experienced At Least One Adverse Event (AE)
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Complete Response Rate (CRR) per Lugano Response Criteria
Complete Response Rate (CRR) per Lugano Response Criteria
次要结局
- Objective Response Rate (ORR) per Lugano Response Criteria
- Duration of Response (DOR) per Lugano Response Criteria
研究者
Puja Patel
Scientific
Merck Sharp & Dohme LLC
研究点 (11)
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