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

Phase 2

Conditions: Hodgkin Lymphoma and Non-Hodgkin Lymphoma
10025319

Registration Number: NL-OMON53587

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 2

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 R/R cHL (Cohort 1) and 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 a definitive therapy (eg. HDCT/ASCT).
- high-risk for cHL is defined by early relapse, extranodal disease or B
symptoms at relapse,
extensive disease where radiation therapy was contraindicated at relapse,
and/or relapse in
a prior radiation field.
- Participants with pathologically confirmed R/R NHL after failure or
non-response to first-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).
- high-risk for NHL is defined as applicable (eg, in young adults) by a
second-line therapy
age-adjusted International Prognostic Index score of >= 2 factors.
- 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

- 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
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 LAG-3-targeted agents.
- Participants with prior autologous stem cell transplantation (HDCT/ASCT).
- 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1/Part A- Dose-limiting toxicities (DLTs), Maximum Tolerated Dose/Recommended<br /><br>Phase 2 Dose; (MTD/RP2D), and incidences of Adverse Events (AEs), Serious<br /><br>Adverse Events (SAEs), AEs leading to discontinuation, deaths and laboratory<br /><br>abnormalities<br /><br><br /><br>2/Part A- maximum observed serum concentration (Cmax), trough observed<br /><br>concentration (Ctrough), time to maximum concentration<br /><br>(Tmax), and area under the curve within a dosing interval (AUC(TAU)) for<br /><br>relatlimab<br /><br><br /><br>3/Part B- Complete Metabolic Response (CMR) rate</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1/Part B: Incidences of AEs, SAEs, AEs leading to discontinuation, deaths, and<br /><br>laboratory abnormalities<br /><br><br /><br>2/Part B: Overall Response Rate (ORR)</p><br>