2024-515526-89-00招募中2 期
A Randomized, Open-Label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP versus Polatuzumab Vedotin plus R-CHP in Treatment-naive Participants with GCB Subtype of Diffuse Large B Cell Lymphoma (DLBCL).
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 48
- 主要终点
- Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria
研究概览
简要总结
- To compare zilovertamab vedotin plus R-CHP with polatuzumab vedotin plus R-CHP with respect to CR rate at EOT per Lugano response criteria as assessed by BICR.
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
- 否
入选标准
- •Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (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
- •Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
- •Participants 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
- •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 active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection
- •Has history of stem cell/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
Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria
Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria
次要结局
- Progression-free Survival (PFS) 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)
- Change From Baseline in HRQoL on FACT-Lym Total Score
- Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB), Items General Physical (GP)1 through GP7
- Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score
研究者
Puja Patel
Scientific
Merck Sharp & Dohme LLC
研究点 (48)
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