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

Bristol-Myers Squibb International Corporation0 个研究点目标入组 99 人开始时间: 2023年2月14日最近更新: 2024年4月8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 first-line standard therapy prior to definitive treatment (eg, HDCT/ASCT).
•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).
•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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 57
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 42
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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 (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 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 the study treatment.
•Participants with autoimmune disease.
•Participants who are pregnant or breastfeeding.

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