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
Overview
- Phase
- Phase 1
- Intervention
- Relatlimab
- Conditions
- Lymphoma, Non-Hodgkin
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 5
- Locations
- 124
- Primary Endpoint
- Incidence of dose-limiting toxicities (DLTs)
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
The purpose of this study is to assess the safety, tolerability, drug levels, and preliminary efficacy of relatlimab plus nivolumab in pediatric and young adult participants with recurrent or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants with pathologically confirmed high-risk R/R cHL, after non-response to or failure of 1or more lines of standard therapy.
- •Participants with pathologically confirmed R/R NHL after non-response to or failure of 1or 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), or peripheral T-cell lymphoma (PTCL).
- •Participants with pathologically confirmed R/R NHL after non-response to or failure of 2 or more lines of standard therapy, including 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 non-nasal NK/T-cell lymphoma subtypes, but not aggressive NK/T-cell leukemia/lymphoma subtype).
- •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.
Exclusion Criteria
- •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 (anti-CTLA-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 lymphocyte activation gene-3 (LAG-3)-targeted agents.
- •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.
- •Prior allogeneic bone marrow transplantation.
- •Other protocol-defined inclusion/exclusion criteria apply
Arms & Interventions
Relatlimab + Nivolumab
Intervention: Relatlimab
Relatlimab + Nivolumab
Intervention: Nivolumab
Outcomes
Primary Outcomes
Incidence of dose-limiting toxicities (DLTs)
Time Frame: Up to 135 days following last dose
DLT evaluation window is 4 weeks from start of treatment. Safety evaluation will continue up to 135 days following last dose.
Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D)
Time Frame: Up to 135 days following last dose
Number of participants with Adverse Events (AEs)
Time Frame: Up to 135 days following last dose
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 135 days following last dose
Number of participants with AEs leading to discontinuation
Time Frame: Up to 135 days following last dose
Number of deaths
Time Frame: Up to 2 years from the last treatment of last participant
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 135 days following last dose
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 96 weeks
Trough observed concentration (Ctrough)
Time Frame: Up to 96 weeks
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to 96 weeks
Area Under the Curve within a dosing interval (AUC(TAU))
Time Frame: Up to 96 weeks
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
Time Frame: Up to 2 years from the last treatment of last participant
Secondary Outcomes
- Number of participants with AEs(Up to 135 days following last dose)
- Number of participants with SAEs(Up to 135 days following last dose)
- Number of participants with AEs leading to discontinuation(Up to 135 days following last dose)
- Number of deaths(Up to 2 years from the last treatment of last participant)
- Number of participants with clinical laboratory abnormalities(Up to 135 days following last dose)
- 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(Up to 2 years from the last treatment of last participant)