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 - CA224-069

Bristol Myers Squibb International Corporation0 个研究点目标入组 99 人开始时间: 2023年7月27日最近更新: 2024年7月22日

试验速览

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•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 Recurrent or Refractory Classical Hodgkin Lymphoma (R/R cHL) (Cohort 1) and Non Hodgkin Lymphoma (NHL) (Cohort 2)., Participants with pathologically confirmed high-risk R/R cHL, after non-response to or failure of 1 or more lines of standard therapy., Participants with pathologically confirmed R/R NHL after non-response to or failure of 1 or more lines of standard therapy, including, but not limited to, R/R primary mediastinal B-cell lymphoma, diffuse large B cell lymphoma (DLBCL), mediastinal gray zone lymphoma (MGZL), anaplastic large cell lymphoma (ALCL), Burkitt lymphoma (blast count < 25% malignant Burkitt cells and/or per the investigator's clinical assessment of risk status), lymphoblastic lymphoma (blast count < 25% of marrow nucleated cells and/or per the investigator's clinical assessment of risk status), NK/T-cell lymphoma (nasal and nonnasal NK/T cell lymphoma subtypes, but not aggressive NK/T-cell leukemia/lymphoma subtype), or peripheral T-cell lymphoma (PTCL)., 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 cohorts.

•Primary CNS lymphoma of the brain or spinal cord, and secondary CNS lymphoma (ie, from systemic non-Hodgkin lymphoma) involving the brain, spinal cord, or with leptomeningeal seeding., Prior treatment with an anti-cytotoxic T-lymphocyte-associated protein 4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, with the exception of anti-PD(L)-1 targeted therapies., Prior treatment with LAG-3-targeted agents., 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 the study treatment., Participants with autoimmune disease., Participants who are pregnant or breastfeeding.

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