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.
Inclusion Criteria:
- Pathologically confirmed high-risk recurrent/relapsed or refractory (R/R) classical
Hodgkin lymphoma (cHL), after non-response to or failure of first-line standard
therapy prior to a definitive therapy e.g.high-dose chemotherapy/autologous stem cell
transplant (HDCT/ASCT)
- Participants with pathologically confirmed R/R NHL after failure or non-response to
second 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).
- Participants must have measurable PET positive disease in both cHL and NHL cohorts.
Exclusion Criteria:
- 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 (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
- Prior autologous stem cell transplantation (HDCT/ASCT)
- History of allogeneic bone marrow transplantation.
Other protocol-defined inclusion/exclusion criteria apply
Primary outcome:
1. Incidence of dose-limiting toxicities (DLTs) (Time Frame - Up to 135 days following last dose)
2. Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D) (Time Frame - Up to 135 days following last dose)
3. Number of participants with Adverse Events (AEs) (Time Frame - Up to 135 days following last dose)
4. Number of participants with serious adverse events (SAEs) (Time Frame - Up to 135 days following last dose)
5. Number of participants with AEs leading to discontinuation (Time Frame - Up to 135 days following last dose)
6. Number of deaths (Time Frame - Up to 135 days following last dose)
7. Number of participants with clinical laboratory abnormalities (Time Frame - Up to 135 days following last dose)
8. Maximum observed plasma concentration (Cmax) (Time Frame - Up to 96 weeks)
9. Trough observed concentration (Ctrough) (Time Frame - Up to 96 weeks)
10. Time of maximum observed plasma concentration (Tmax) (Time Frame - Up to 96 weeks)
11. Area Under the Curve within a dosing interval (AUC(TAU)) (Time Frame - Up to 96 weeks)
12. 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 outcome:
1. Number of participants with AEs (Time Frame - Up to 135 days following last dose)
2. Number of participants with SAEs (Time Frame - Up to 135 days following last dose)
3. Number of participants with AEs leading to discontinuation (Time Frame - Up to 135 days following last dose)
4. Number of deaths (Time Frame - Up to 135 days following last dose)
5. Number of participants with clinical laboratory abnormalities (Time Frame - Up to 135 days following last dose)
6. 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 (Time Frame - Up to 2 years from the last treatment of last participant)
- Relatlimab (BMS-986016):
Specified Dose on Specified Days - Nivolumab (BMS-936558):
Specified Dose on Specified Days
Quelle: ClinicalTrials.gov
