NL-OMON53587尚未招募2 期
A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants with Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma - RELATIVITY-069
Bristol-Myers Squibb0 个研究点目标入组 2 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2
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
- 2 至 64（—）
入选标准
- •- Male and female participants less than 18 years of age (Part A), and less
- •than or equal to
- •30 years of age (Part B) with R/R cHL (Cohort 1) and NHL (Cohort 2).
- •- Participants with pathologically confirmed high-risk R/R cHL, after
- •non-response to or failure
- •of first-line standard therapy prior to a definitive therapy (eg. HDCT/ASCT).
- •- high-risk for cHL is defined by early relapse, extranodal disease or B
- •symptoms at relapse,
- •extensive disease where radiation therapy was contraindicated at relapse,
- •and/or relapse in
- •a prior radiation field.
- •- Participants with pathologically confirmed R/R NHL after failure or
- •non-response to first-line
- •therapy, including but not limited to primary mediastinal B-cell lymphoma,
- •diffuse large B-cell
- •lymphoma (DLBCL), mediastinal gray zone lymphoma (MGZL), anaplastic large cell
- •lymphoma (ALCL), or peripheral T-cell lymphoma (PTCL).
- •- high-risk for NHL is defined as applicable (eg, in young adults) by a
- •second-line therapy
- •age-adjusted International Prognostic Index score of >= 2 factors.
- •- The participant*s current disease state must be R/R to standard therapy.
- •- Participants must have measurable PET positive disease in both cHL and NHL
排除标准
- •- Aggressive B-cell lymphomas subtypes including Burkitt lymphoma (BL),
- •lymphoblastic
- •lymphoma, and NK/T-cell lymphoma/leukemia.
- •- Primary CNS lymphoma of the brain or spinal cord, and secondary CNS lymphoma
- •systemic non-Hodgkin lymphoma) involving the brain, spinal cord, or with
- •leptomeningeal
- •- Prior treatment with an anti-cytotoxic T-lymphocyte-associated protein 4
- •antibody, or any
- •other antibody or drug specifically targeting T-cell co-stimulation or
- •checkpoint pathways,
- •with the exception of anti-PD(L)-1 targeted therapies.
- •- Prior treatment with LAG-3-targeted agents.
- •- Participants with prior autologous stem cell transplantation (HDCT/ASCT).
- •- Participants with a history of allogeneic bone marrow transplantation.
- •- Participants with clinically significant systemic illnesses unrelated to the
- •cancer as judged by
- •the investigators, which would compromise the participant*s ability to tolerate
- •- Participants with autoimmune disease.
- •- Participants who are pregnant or breastfeeding.
研究者
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