2024-515566-13-00招募中3 期
A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 265
- 试验地点
- 64
- 主要终点
- Progression-free Survival (PFS) per Lugano Response Criteria
研究概览
简要总结
To compare zilovertamab vedotin plus R-CHP with R-CHOP with respect to PFS per Lugano response criteria as assessed by 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
- 否
入选标准
- •Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues.
- •Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale.
- •Has received no prior treatment for their DLBCL.
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization.
- •Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)
- •Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
- •Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization
- •Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
排除标准
- •Has a history of transformation of indolent disease to DLBCL
- •Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- •Known additional malignancy that is progressing or has required active treatment within the past 2 years
- •Known active central nervous system (CNS) lymphoma.
- •Has active autoimmune disease that has required systemic treatment in the past 2 years
- •Has active infection requiring systemic therapy.
- •Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection.
- •Has history of allogeneic tissue/solid organ transplant
- •Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma
- •Has Ann Arbor Stage I DLBCL
- •Has clinically significant (i.e., 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 clinically significant pericardial or pleural effusion.
- •Has ongoing Grade >1 peripheral neuropathy.
- •Has a demyelinating form of Charcot-Marie-Tooth disease.
- •HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
- •Has ongoing corticosteroid therapy
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Progression-free Survival (PFS) per Lugano Response Criteria
Progression-free Survival (PFS) per Lugano Response Criteria
次要结局
- Complete Response (CR) at End of Treatment (EOT) per Lugano Response Criteria
- Overall Survival (OS)
- Event-free Survival (EFS) per Lugano Response Criteria
- Duration of CR
- Number of Participants Who Experienced At Least One Adverse Event (AE)
- Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
- Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI) Score
- Change From Baseline in HRQoL on FACT-Lym Total Score
- Change From Baseline in HRQoL on FACT-Lym Physical Wellbeing (PWB) score
- Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score
研究者
Nishitha Reddy
Scientific
Merck Sharp & Dohme LLC
研究点 (64)
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