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: 2022年2月16日最近更新: 2022年5月30日

适应症

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 HDCT/ASCT.
•Participants with pathologically confirmed high-risk, R/R NHL after failure or non-response to first-line therapy
•Participants must have measurable FDG-PET-CT 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 0

•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 and with active graft versus host disease (GVHD) and prior history of Grade > 2 GVHD.
•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.

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