Relatlimab + Nivolumab in Pediatric and Young Adult Lymphomas(RELATIVITY-069)
- Conditions
- Recurrent or Refractory Classical Hodgkin Lymphoma and Non-HodgkinLymphomaMedDRA version: 20.1Level: LLTClassification code: 10080208Term: Classical Hodgkin lymphoma Class: 10029104MedDRA version: 20.0Level: HLGTClassification code: 10025320Term: Lymphomas non-Hodgkin's B-cell Class: 10029104MedDRA version: 20.0Level: HLGTClassification code: 10025322Term: Lymphomas non-Hodgkin's unspecified histology Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-503715-14-00
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 99
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method