Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma MedDRA version: 20.1 Level: LLT Classification code 10080208 Term: Classical Hodgkin lymphoma System Organ Class: 100000004864 MedDRA version: 20.0 Level: HLGT Classification code 10025322 Term: Lymphomas non-Hodgkin's unspecified histology System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ
Conditions
Interventions
Product Name: Anti-LAG-3
Product Code: [BMS-986016]
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: relatlimab
Current Sponsor code: BMS-986016
Concentration unit: mg/ml mill
Sponsors
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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: 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
Exclusion criteria
Exclusion criteria: • 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A: To characterize the safety, tolerability, and define the MTD or RP2D for the combination of relatlimab + nivolumab in pediatric participants less than 18 years of age with R/R cHL and NHL. Part A: To characterize the PK of relatlimab for the combination of relatlimab + nivolumab in pediatric participants less than 18 years of age with R/R cHL and NHL. Part B: To assess the preliminary efficacy of relatlimab + nivolumab based on the RP2D from part A in participants less than or equal to 30 years old with cHL (Cohort 1).;Secondary Objective: Part B: To assess the safety of relatlimab + nivolumab in R/R cHL (Cohort 1) and NHL (Cohort2) Part B: To evaluate the ORR of relatlimab + nivolumab in participants <= 30 years of age with cHL (Cohort 1);Primary end point(s): 1/Part A- Dose-limiting toxicities (DLTs), Maximum Tolerated Dose/Recommended Phase 2 Dose; (MTD/RP2D), and incidences of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation, deaths and laboratory abnormalities 2/Part A- maximum observed serum concentration (Cmax), trough observed concentration (Ctrough), time to maximum concentration (Tmax), and area under the curve within a dosing interval (AUC(TAU)) for relatlimab 3/Part B- Complete Metabolic Response (CMR) rate;Timepoint(s) of evaluation of this end point: 1/Up to 100 days after the last dose of study Treatment 2/At specified timepoints in Section 9.5 of the protocol 3/Up to 32 weeks from last patient first treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/Part B: Incidences of AEs, SAEs, AEs leading to discontinuation, deaths, and laboratory abnormalities 2/Part B: Overall Response Rate (ORR);Timepoint(s) of evaluation of this end point: 1/Up to 100 days after the last dose of study Treatment 2/Up to 2 years after LPFT | — |
Countries
Australia, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactGSM-CT
Bristol-Myers Squibb International Corporation
Outcome results
None listed