A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adults With Hodgkin and Non-Hodgkin Lymphoma
- Conditions
- Lymphoma, Non-HodgkinHodgkin Disease
- Registration Number
- NCT05255601
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Pathologically confirmed high-risk recurrent/relapsed or refractory (R/R) classical<br> Hodgkin lymphoma (cHL), after non-response to or failure of first-line standard<br> therapy prior to a definitive therapy e.g.high-dose chemotherapy/autologous stem<br> cell transplant (HDCT/ASCT)<br><br> - Participants with pathologically confirmed R/R NHL after failure or non-response to<br> second line therapy, including but not limited to primary mediastinal B-cell<br> lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal gray zone lymphoma<br> (MGZL), anaplastic large cell lymphoma (ALCL), or peripheral T-cell lymphoma (PTCL).<br><br> - Participants must have measurable PET positive disease in both cHL and NHL cohorts.<br><br>Exclusion Criteria:<br><br> - Aggressive B-cell lymphomas subtypes including Burkitt lymphoma (BL), lymphoblastic<br> lymphoma, and NK/T-cell lymphoma/leukemia.<br><br> - Primary CNS lymphoma of the brain or spinal cord, and secondary CNS lymphoma (ie,<br> from systemic non-Hodgkin lymphoma) involving the brain, spinal cord, or with<br> leptomeningeal seeding.<br><br> - Prior treatment with an anti-cytotoxic T-lymphocyte-associated protein 4<br> (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell<br> co-stimulation or checkpoint pathways, with the exception of anti-PD(L)-1 targeted<br> therapies<br><br> - Prior treatment with lymphocyte activation gene-3 (LAG-3)-targeted agents<br><br> - Prior autologous stem cell transplantation (HDCT/ASCT)<br><br> - History of allogeneic bone marrow transplantation.<br><br>Other protocol-defined inclusion/exclusion criteria apply
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of dose-limiting toxicities (DLTs);Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D);Number of participants with Adverse Events (AEs);Number of participants with serious adverse events (SAEs);Number of participants with AEs leading to discontinuation;Number of deaths;Number of participants with clinical laboratory abnormalities;Maximum observed plasma concentration (Cmax);Trough observed concentration (Ctrough);Time of maximum observed plasma concentration (Tmax);Area Under the Curve within a dosing interval (AUC(TAU));Complete Metabolic Response (CMR) Rate defined as the proportion of all response-evaluable participants who achieve the best response of CMR using Lugano 2014 criteria
- Secondary Outcome Measures
Name Time Method Number of participants with AEs;Number of participants with SAEs;Number of participants with AEs leading to discontinuation;Number of deaths;Number of participants with clinical laboratory abnormalities;Overall Response Rate (ORR) defined as the proportion of all response- evaluable participants who achieve a best response of CMR or partial metabolic response (PMR) using the Lugano 2014 classification